Poisons Standard 2010

PART 4

THE SCHEDULES

SCHEDULE 1

This Schedule is intentionally blank.

SCHEDULE 2

ACETIC ACID (excluding its salts and derivatives) and preparations containing

more than 80 per cent of acetic acid (CH3COOH) for therapeutic use.

ACETYLCYSTEINE in preparations for oral use except when labelled with a recommended daily dose of 1 g or less of acetylcysteine.

ACONITUM spp. for therapeutic use in adults:

(a) in preparations for oral use in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids; or

(b) in preparations for dermal use containing 0.02 per cent or less of total alkaloids, in packs each containing 0.2 mg or less of total alkaloids except in packs containing 0.02 mg or less of total alkaloids.

ALOXIPRIN.

AMETHOCAINE in preparations for topical use other than eye drops, containing 10 per cent or less of total local anaesthetic substances except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

AMOROLFINE in preparations for topical use except in preparations for the treatment of tinea pedis.

ANTAZOLINE in eye drops.

ASPIRIN except:

(a) when included in Schedule 4, 5 or 6;

(b) in individually wrapped powders or sachets of granules each containing 650 mg or less of aspirin as the only therapeutically active constituent other than an effervescent agent when:

(i) enclosed in a primary pack that contains 12 or less such powders or sachets of granules; and

(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(c) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:

(ii) in a primary pack of not more than 25 tablets or capsules, each containing 325 mg or less of aspirin, or in a primary pack of not more than 16 tablets or capsules, each containing 500 mg or less of aspirin; and

(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(d) in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when:

(ii) in a primary pack containing 100 or less tablets or capsules, each containing 100 mg

or less of aspirin when packed and labelled for the prevention of cardiovascular disease or for the inhibition of platelet aggregation; and

(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels.

ATROPA BELLADONNA (belladonna):

(a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or

(i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

ATROPINE (excluding atropine methonitrate) for oral use:

(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

AZELAIC ACID in dermal preparations.

AZELASTINE in preparations for nasal use.

BECLOMETHASONE in aqueous nasal sprays delivering 50 micrograms or less of beclomethasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

BENZOCAINE in preparations for topical use other than eye drops:

(a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or

(b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

BENZOYL PEROXIDE in preparations for human external therapeutic use containing 10 per cent or less of benzoyl peroxide except in preparations containing 5 per cent or less of benzoyl peroxide.

BENZYDAMINE in preparations for topical use, except in preparations for dermal use.

BEPHENIUM SALTS.

BIFONAZOLE in preparations for dermal use except:

(a) in preparations containing 1 per cent or less of bifonazole for the treatment of the scalp; or

BROMHEXINE.

BROMPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:

(b) in a day-night pack containing brompheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

BUDESONIDE in aqueous nasal sprays delivering 50 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

CARBETAPENTANE except in preparations containing 0.5 per cent or less of carbetapentane.

CARBOCISTEINE.

CETIRIZINE in preparations for oral use.

CHLOPHEDIANOL.

CHLORBUTOL for human use in topical preparations containing 5 per cent or less of chlorbutol except in preparations containing 0.5 per cent or less of chlorbutol.

CHLOROFORM in preparations for therapeutic use except:

(b) in preparations containing 0.5 per cent or less of chloroform.

CHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:

(b) in a day-night pack containing chlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

CICLOPIROX in preparations for dermal use and for application to the nails containing 2 per cent or less of ciclopirox except in preparations for the treatment of tinea pedis.

CINCHOCAINE in preparations for topical use other than eye drops, containing 0.5 per cent or less of total local anaesthetic substances.

CINNAMEDRINE.

CLOTRIMAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.

CODEINE in preparations for the treatment of coughs and colds when:

(a) not combined with any other opiate substance;

(b) compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance:

(i) in divided preparations containing 10 mg or less of codeine per dosage unit; or

(ii) in undivided preparations containing 0.25 per cent or less of codeine;

(c) labelled with a recommended daily dose not exceeding 60 mg of codeine; and

(d) in packs containing not more than 6 days' supply at the maximum dose recommended on the label.

CREOSOTE derived from wood other than beechwood for human therapeutic use, except in preparations containing 10 per cent or less of creosote derived from wood other than beechwood.

DATURA spp. for oral use:

(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids, or

(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

except when separately specified in these Schedules.

DATURA STRAMONIUM (stramonium) for oral use when:

(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

except for smoking or burning.

DATURA TATULA (stramonium) for oral use:

(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

except for smoking or burning.

DELPHINIUM STAPHISAGRIA except in preparations containing 0.2 per cent or less of Delphinium staphisagria.

DESLORATADINE in preparations for oral use.

DEXCHLORPHENIRAMINE when combined with one or more other therapeutically active substances in oral preparations when:

(b) in a day-night pack containing dexchlorpheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

DEXTROMETHORPHAN (excluding its stereoisomers) when supplied in a pack containing 600 mg or less of dextromethorphan and with a recommended daily dose of 120 mg or less of dextromethorphan.

DIBROMOPROPAMIDINE for ophthalmic use.

DICLOFENAC in divided preparations for oral use containing 12.5 mg or less of diclofenac per dosage unit in a pack containing 20 or less dosage units and labelled with a recommended daily dose of 75 mg or less of diclofenac.

DIHYDROCODEINE when compounded with aspirin and no other therapeutically active substance in divided preparations:

(a) containing 5 mg or less of dihydrocodeine per dosage unit;

(b) packed in blister or strip packaging or in a container with a child-resistant closure;

(c) enclosed in primary packs containing 25 or less dosage units; and

(d) labelled with a recommended dose not exceeding 10 mg of dihydrocodeine.

DIMENHYDRINATE in primary packs of 10 doses or less for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.

DIPHENHYDRAMINE in oral preparations:

(a) in a primary pack containing 10 dosage units or less for the prevention or treatment of motion sickness; or

(b) when combined with one or more other therapeutically active substances when:

(ii) in a day-night pack containing diphenhydramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

DOXYLAMINE when combined with one or more other therapeutically active substances in oral preparations when:

(b) in a day-night pack containing doxylamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

DUBOISIA LEICHHARDTII for oral use:

(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

DUBOISIA MYOPOROIDES for oral use:

(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(b) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

ECONAZOLE for human use in dermal preparations except in preparations for the treatment of tinea pedis.

ETAFEDRINE.

ETHER for therapeutic use except:

(b) in preparations containing 10 per cent or less of ether.

ETHYLMORPHINE when:

(a) compounded with one or more other therapeutically active substances:

(i) in divided preparations containing 10 mg or less of ethylmorphine per dosage unit; or

(ii) in undivided preparations containing 0.25 per cent or less of ethylmorphine; and

(b) labelled with a recommended dose not exceeding 15 mg of ethylmorphine.

ETOFENAMATE in preparations for external use.

FAMOTIDINE when sold in the manufacturer’s original pack containing not more than 14 days' supply.

FELBINAC in preparations for external use.

FEXOFENADINE in preparations for oral use.

FLUORIDES for human use:

(a) in preparations for ingestion containing 0.5 mg or less of fluoride ion per dosage unit; or

(b) in liquid preparations for topical use containing 1000 mg/kg or less of fluoride ion, in a container SCHEDULE 2 – continued

with a child-resistant closure:

(i) for therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels except in preparations containing 220 mg/kg or less

of fluoride ion, in packs containing not more than 120 mg total fluoride when fitted with a child-resistant closure and compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

(ii) for non-therapeutic use when labelled with warnings to the following effect:

(B) Do not use [this product/name of product] in children six years of age or less,

except in preparations containing 220 mg/kg or less of fluoride ion, in packs containing not more than 120 mg total fluoride, when fitted with a child-resistant closure and labelled with warnings to the following effect:

(B) Do not use [this product/name of product] in children six years of age or less,

except in preparations containing 15 mg/kg or less of fluoride ion or preparations for supply to registered dental professionals or by approval of an appropriate authority.

FLURBIPROFEN in preparations for topical oral use when:

(a) in divided preparations containing 10 mg or less of flurbiprofen per dosage unit; or

(b) in undivided preparations containing 0.25 per cent or less, or 10 mg or less per dose, of flurbiprofen.

FLUTICASONE in aqueous nasal sprays delivering 50 micrograms or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 micrograms and when packed in a primary pack containing 200 actuations or less, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

FOLIC ACID for human therapeutic use except:

(b) in preparations containing 500 micrograms or less of folic acid
per recommended daily dose.

FOLINIC ACID for human therapeutic use except:

(b) in preparations containing 500 micrograms or less of folinic acid
per recommended daily dose.

† FORMALDEHYDE (excluding its derivatives) for human therapeutic use except:

(a) in oral hygiene preparations containing 0.1 per cent or less of free formaldehyde; or

(b) in other preparations containing 0.2 per cent or less of free formaldehyde.

GUAIPHENESIN in a modified release dosage form of 1200 mg or less of guaiphenesin with a recommended daily dose of 2400 mg or less when not labelled for the treatment of children under 12 years of age.

GELSEMIUM SEMPERVIRENS.

GLUTARALDEHYDE for human therapeutic use.

HEXACHLOROPHANE in preparations for human use containing 3 per cent or less

of hexachlorophane except:

(a) in preparations containing 0.75 per cent or less of hexachlorophane; or

(b) in preparations for use on infants, as specified in Schedule 4.

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 0.5 per cent or less of hydrocortisone:

(a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or

(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:

(i) in undivided preparations in packs of 35 g or less; or

(ii) in packs containing 12 or less suppositories.

HYDROQUINONE (excluding monobenzone and other alkyl ethers of hydroquinone included in Schedule 4) in preparations for human external therapeutic or cosmetic use containing 2 per cent or less of hydroquinone except in hair preparations containing 0.3 per cent or less of hydroquinone.

8-HYDROXYQUINOLINE and its non-halogenated derivatives for human therapeutic use, except in preparations for external use containing 1 per cent or less of such substances.

HYOSCINE (excluding hyoscine butylbromide):

(a) for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or

(i) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.

HYOSCYAMINE:

(a) for external use in preparations containing 0.03 per cent or less of total solanaceous alkaloids; or

(i) in undivided preparations containing 0.03 per cent or less of total solanaceous

alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(ii) in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less total solanaceous alkaloids.

HYOSCYAMUS NIGER for oral use:

(a) in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or

(b) in divided preparations containing 0.3 mg of total solanaceous alkaloids or less per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids,

except in a pack containing 0.03 mg or less of total solanaceous alkaloids.

IBUPROFEN in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen:

(a) in liquid preparations when sold in the manufacturer’s original pack containing 4 grams or less of ibuprofen; or

(b) in divided preparations, each containing 200 mg or less of ibuprofen, in packs of not more than 100 dosage units except when:

(i) as the only therapeutically active constituent other than an effervescent agent;

(ii) packed in blister or strip packaging or in a container with a child-resistant closure;

(iii) in a primary pack containing not more than 25 dosage units;

(iv) not labelled for the treatment of children 6 years of age or less; and

(v) compliant with the requirements of the Required Advisory Statements for Medicine Labels.

INDANAZOLINE.

INDOMETHACIN in preparations for external use containing 1 per cent or less of indomethacin.

IODINE:

(a) in preparations for human internal therapeutic use containing 300 micrograms or more of iodine per recommended daily dose; or

(b) in preparations for human external therapeutic use containing more than 2.5 per cent of available iodine (excluding salts, derivatives or iodophors),

except in oral preparations for use in prophylaxis and treatment in the event of radioactive iodine exposure under an emergency plan approved by an appropriate authority.

IPRATROPIUM in preparations for nasal use.

IRON COMPOUNDS (excluding iron oxides when present as an excipient, in divided preparations containing 10 mg or less of total iron oxides per dosage unit or in undivided preparations containing 1 per cent or less of total iron oxides) for human internal use except:

(b) when labelled with a recommended daily dose of 24 mg or less of iron:

(i) in undivided preparations supplied in packs each containing 750 mg or less of iron; or

(ii) in divided preparations:

(A) containing more than 5 mg of iron per dosage unit in packs each containing 750 mg or less of iron; or

(B) containing 5 mg or less of iron per dosage unit.

ISOCONAZOLE for human use in dermal preparations.

ISOPROPAMIDE in preparations for dermal use containing 2 per cent or less of isopropamide.

KETOCONAZOLE in preparations for dermal use except:

(a) in preparations containing 1 per cent or less of ketoconazole for the treatment of the scalp; or

KETOTIFEN for ophthalmic use in preparations containing 0.025 per cent or less of ketotifen.

LEVOCABASTINE in topical eye or nasal preparations.

LIGNOCAINE in preparations for topical use other than eye drops:

(a) containing 10 per cent or less of total local anaesthetic substances, except in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or

(b) in divided preparations containing 200 mg or less of total local anaesthetic substances per dosage unit, except in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

LINDANE in preparations for human external therapeutic use containing 2 per cent or less of lindane.

LITHIUM in preparations for dermal use containing 1 per cent or less of lithium except:

(a) when present as an excipient at 0.25 per cent or less of lithium; or

(b) in preparations containing 0.01 per cent or less of lithium.

LOBELIA INFLATA except for smoking or burning.

LOBELINE except in preparations for smoking or burning.

LODOXAMIDE in preparations for ophthalmic use.

LOPERAMIDE in divided preparations for oral use in packs of 20 dosage units or less.

LORATADINE in preparations for oral use.

MEBENDAZOLE for human therapeutic use.

MECLOZINE in primary packs containing 12 or less tablets or capsules of meclozine for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age.

MEFENAMIC ACID in divided preparations for oral use in packs of 30 or less dosage units for the treatment of dysmenorrhoea.

MEPYRAMINE for dermal use.

MERCUROCHROME in preparations for external use containing 2 per cent or less of mercurochrome.

MERCURY for external use in preparations containing 0.5 per cent or less of mercury.

METHOXAMINE in preparations for external use except in preparations containing 1 per cent or less of methoxamine.

METHOXYPHENAMINE.

METHYLEPHEDRINE.

MICONAZOLE for human use in dermal preparations and for application to the nails except in preparations for the treatment of tinea pedis.

MINOXIDIL in preparations for dermal use containing 5 per cent or less of minoxidil.

MOMETASONE in aqueous nasal sprays delivering 50 micrograms or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 micrograms for the prophylaxis or treatment of allergic rhinitis for up to six months in adults and children 12 years of age and over.

NAPHAZOLINE.

NAPROXEN in divided preparations containing 250 mg or less of naproxen per dosage unit in packs of 30 or less dosage units.

NICLOSAMIDE for human therapeutic use.

NICOTINE for use as an aid in withdrawal from tobacco smoking in preparations for inhalation.

NIZATIDINE when sold in the manufacturer’s original pack containing not more than 14 days supply.

NOSCAPINE.

NYSTATIN in dermal preparations.

OXETACAINE (oxethazaine) in preparations for internal use.

OXICONAZOLE for dermal use except in preparations for the treatment of tinea pedis.

OXYMETAZOLINE.

PAPAVERINE except when included in Schedule 4.

PARACETAMOL for therapeutic use except:

(b) in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or

guaiphenesin or when combined with effervescent agents) when:

(i) enclosed in a primary pack that contains not more than 12 such powders or sachets of granules;

(ii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(iii) not labelled for the treatment of children 6 years of age or less; and

(iv) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin; or

(c) in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than phenylephrine and/or guaiphenesin or when combined with effervescent agents) when:

(ii) in a primary pack containing not more than 25 tablets or capsules;

(iii) compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(iv) not labelled for the treatment of children 6 years of age or less; and

(v) not labelled for the treatment of children under 12 years of age when combined with phenylephrine and/or guaiphenesin.

† PARAFORMALDEHYDE (excluding its derivatives) for human therapeutic use except:

(a) in oral hygiene preparations containing 0.1 per cent or less of free formaldehyde; or

(b) in other preparations containing 0.2 per cent or less of free formaldehyde.

PENCICLOVIR for external use for the treatment of herpes labialis.

PHEDRAZINE.

PHENAZONE for human external use.

PHENIRAMINE:

(a) in eye drops; or

(b) when combined with one or more other therapeutically active substances in oral preparations when:

(ii) in a day-night pack containing pheniramine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

PHENOL, or any homologue boiling below 220°C, for human therapeutic use except:

(b) in preparations for external use containing 3 per cent or less of such substances.

PHENYLEPHRINE except:

(b) in oral preparations containing 50 mg or less of phenylephrine per recommended daily dose in packs containing 250 mg or less of phenylephrine; or

(c) in topical eye or nasal preparations containing 1 per cent or less of phenylephrine.

PHOLCODINE:

(a) in liquid preparations containing 0.5 per cent or less of pholcodine and with a recommended dose not exceeding 25 mg of pholcodine; or

(b) when compounded with one or more other therapeutically active substances in divided preparations containing 10 mg or less of pholcodine per dosage unit and with a recommended dose not exceeding 25 mg of pholcodine.

PIPERAZINE for human therapeutic use.

PODOPHYLLOTOXIN in preparations containing 0.5 per cent or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts.

PODOPHYLLUM EMODI (podophyllin) in preparations containing 10 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts.

PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 10 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts.

POTASSIUM CHLORATE for therapeutic use except in preparations containing 10 per cent or less of potassium chlorate.

PRILOCAINE in preparations for dermal use containing 10 per cent or less of total local anaesthetic substances.

PROCYCLIDINE in preparations containing 5 per cent or less of procyclidine for dermal use.

PROMETHAZINE in oral preparations:

(a) in a primary pack containing 10 dosage units or less for the prevention or treatment of motion sickness; or

(b) when combined with one or more other therapeutically active substances when:

(ii) in a day-night pack containing promethazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

PROPAMIDINE for ophthalmic use.

PYRANTEL for human therapeutic use.

PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or

pyrethric acids, for human therapeutic use in preparations containing more than 10 per cent of such substances.

PYRITHIONE ZINC for human therapeutic use, except in preparations for the treatment of the scalp containing 2 per cent or less of pyrithione zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.

RANITIDINE in preparations supplied in the manufacturer’s original pack containing not more than 14 days' supply except in divided preparations for oral use containing 150 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 14 dosage units.

SALICYLAMIDE except when included in Schedule 4.

SELENIUM in preparations for human therapeutic use except:

(a) for topical use containing 3.5 per cent or less of selenium sulfide;

(b) when included in Schedule 4; or

(c) for oral use with a recommended daily dose of 150 micrograms or less.

SILVER for therapeutic use except:

(a) in solutions for human oral use containing 0.3 per cent or less of silver when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

(b) in other preparations containing 1 per cent or less of silver.

SODIUM CROMOGLYCATE in preparations for nasal or ophthalmic use.

SODIUM NITRITE for therapeutic use (excluding when present as an excipient).

SQUILL except in preparations containing 1 per cent or less of squill.

SULCONAZOLE in preparations for dermal use.

TERBINAFINE for dermal use except in preparations for the treatment of tinea pedis.

TETRACHLOROETHYLENE for human therapeutic use.

TETRAHYDROZOLINE.

THIABENDAZOLE for human therapeutic use.

TIOCONAZOLE in preparations for dermal use except in preparations for the treatment of tinea pedis.

TRAMAZOLINE.

TRIAMCINOLONE in aqueous nasal sprays delivering 55 micrograms or less of triamcinolone per actuation when the maximum recommended daily dose is no greater than 220 micrograms, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

TRIMEPRAZINE when combined with one or more other therapeutically active substances in solid oral preparations when:

(b) in a day-night pack containing trimeprazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

TRIPROLIDINE when combined with one or more other therapeutically active substances in oral preparations when:

(b) in a day-night pack containing triprolidine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

TUAMINOHEPTANE.

TYMAZOLINE.

XYLOMETAZOLINE.

ZINC CHLORIDE for human dermal use except in preparations containing 5 per cent or less of zinc chloride.

SCHEDULE 3

ADRENALINE in preparations containing 1 per cent or less of adrenaline except in preparations containing 0.02 per cent or less of adrenaline.

ALCLOMETASONE as the only therapeutically active substance in preparations for dermal use containing

0.05 per cent or less of alclometasone in packs containing 30 g or less of the preparation.

AMINOPHYLLINE in liquid oral preparations containing 2 per cent or less of aminophylline.

AZATADINE in oral preparations.

AZELASTINE in topical eye preparations containing 0.05 per cent or less of azelastine.

BROMPHENIRAMINE in oral preparations except:

BUCLIZINE in oral preparations.

BUTOCONAZOLE in preparations for vaginal use.

CHLORAMPHENICOL for ophthalmic use only.

CHLORBUTOL in preparations for human use except:

(b) in preparations containing 0.5 per cent or less of chlorbutol.

CHLORPHENIRAMINE in oral preparations except:

CICLOPIROX in preparations for dermal use and for application to the nails except:

CIMETIDINE in a primary pack containing not more than 14 days' supply.

CLEMASTINE in preparations for oral use.

CLOBETASONE (clobetasone-17-butyrate) as the only therapeutically active substance in preparations for dermal use containing 0.05 per cent or less of clobetasone in packs containing 30 g or less of the preparation.

CLOTRIMAZOLE in preparations for vaginal use.

CODEINE when:

(a) not combined with any other opiate substance;

(b) compounded with one or more other therapeutically active substances, of which not more than one is an analgesic substance:

(i) in divided preparations containing 12 mg or less of codeine per dosage unit; or

(ii) in undivided preparations containing 0.25 per cent or less of codeine;

(c) labelled with a recommended daily dose not exceeding 100 mg of codeine; and

(d) in packs containing not more than 5 days of supply at the maximum dose recommended on the label,

CYCLIZINE in preparations for oral use.

CYPROHEPTADINE in oral preparations.

DEXCHLORPHENIRAMINE in oral preparations except:

DICLOFENAC in divided preparations for oral use containing 25 mg or less of diclofenac per dosage unit in a pack containing 30 or less dosage units except when included in Schedule 2.

DIHYDROCODEINE when compounded with one or more other therapeutically active substances:

(a) in divided preparations containing 10 mg or less per dosage unit and with a recommended dose not exceeding 15 mg of dihydrocodeine; or

(b) in undivided preparations containing 0.25 per cent or less of dihydrocodeine with a recommended dose not exceeding 15 mg of dihydrocodeine,

DI-IODOHYDROXYQUINOLINE (iodoquinol) for vaginal use.

DIMENHYDRINATE in oral preparations except when included in Schedule 2.

DIMETHINDENE in oral preparations.

DIPHENHYDRAMINE in oral preparations except:

DIPHENOXYLATE in packs of 8 or less dosage units, each dosage unit containing 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate.

DITHRANOL for therapeutic use.

DOXYLAMINE in oral preparations except:

ECONAZOLE in preparations for vaginal use.

ERYTHRITYL TETRANITRATE for therapeutic use.

FLAVOXATE.

FLUCONAZOLE in single-dose oral preparations containing 150 mg or less of fluconazole for the treatment of vaginal candidiasis.

FLUORIDES for human topical use:

(a) in liquid preparations containing 5500 mg/kg or less of fluoride ion, in a container with a child-resistant closure except when included in or expressly excluded from Schedule 2; or

(b) in non-liquid preparations containing 5500 mg/kg or less of fluoride ion except:

(i) in preparations for therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(ii) in preparations for non-therapeutic use containing 1500 mg/kg or less of fluoride ion and, when containing more than 1000 mg/kg fluoride ion, labelled with warnings to the following effect:

(B) Do not use [this product/name of product] in children six years of age or less; or

(iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority.

GLUCAGON.

GLYCERYL TRINITRATE:

(a) in preparations for oral use; or

(b) in preparations for rectal use.

GLYCOPYRRONIUM except when included in Schedule 4.

HYDROCORTISONE and HYDROCORTISONE ACETATE, but excluding other salts and derivatives, in preparations for human therapeutic use containing 1 per cent or less of hydrocortisone:

(a) for dermal use, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance; or

(b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents:

(i) in undivided preparations, in packs of 35 g or less; or

(ii) in packs containing 12 or less suppositories,

IBUPROFEN in divided preparations, each containing 400 mg or less of ibuprofen, in a primary pack containing not more than 50 dosage units when labelled:

(a) with a recommended daily dose of 1200 mg or less of ibuprofen; and

(b) not for the treatment of children under 12 years of age,

except when included in or expressly excluded from Schedule 2.

INOSITOL NICOTINATE.

ISOCONAZOLE in preparations for vaginal use.

ISOSORBIDE DINITRATE in oral preparations containing 10 mg or less of isosorbide dinitrate per dosage unit.

KETOPROFEN in divided preparations for oral use containing 25 mg or less of ketoprofen per dosage unit in a pack containing 30 or less dosage units.

LANSOPRAZOLE in oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.

LEVONORGESTREL for emergency post-coital contraception.

MACROGOLS in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures.

MAGNESIUM SULFATE for human therapeutic use in divided oral preparations except when containing 1.5 g or less of magnesium sulfate per recommended daily dose.

Malathion in preparations for human external use except in preparations containing 2 per cent or less of malathion.

MANNITYL HEXANITRATE for therapeutic use.

MEPYRAMINE in oral preparations.

METHDILAZINE in oral preparations.

METOCLOPRAMIDE when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units.

MICONAZOLE for human use in topical preparations:

(a) for the treatment of oral candidiasis; or

(b) for vaginal use.

NICOTINIC ACID for human therapeutic use in divided preparations containing 250 mg or less of nicotinic acid per dosage unit except:

(a) in preparations containing 100 mg or less of nicotinic acid per dosage unit; or

(b) nicotinamide.

NICOTINYL ALCOHOL except in preparations containing 100 mg or less of nicotinyl alcohol per dosage unit.

NYSTATIN in preparations for topical use except when included in Schedule 2.

OMEPRAZOLE in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.

ORLISTAT in oral preparations for weight-control purposes containing 120 mg or less of orlistat per dosage unit.

OXICONAZOLE in preparations for vaginal use.

PANTOPRAZOLE in oral preparations containing 20 mg or less of pantoprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.

PHENIRAMINE in oral preparations except:

PODOPHYLLOTOXIN in preparations containing 1 per cent or less of podophyllotoxin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.

PODOPHYLLUM EMODI (podophyllin) in preparations containing 20 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.

PODOPHYLLUM PELTATUM (podophyllin) in preparations containing 20 per cent or less of podophyllin for human use for the treatment of warts other than anogenital warts except when included in Schedule 2.

PROCHLORPERAZINE in divided preparations for oral use in packs containing not more than 10 dosage units for the treatment of nausea associated with migraine.

PROMETHAZINE in oral preparations except:

(b) in preparations for the treatment of children under 2 years of age.

PSEUDOEPHEDRINE (other than preparations for stimulant, appetite suppression or weight-control purposes) when supplied in a primary pack:

(a) in liquid preparations containing 800 mg or less of pseudoephedrine hydrochloride (or its equivalent); or

(b) in other preparations containing 720 mg or less of pseudoephedrine hydrochloride (or its equivalent).

RABEPRAZOLE in oral preparations containing 10 mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days' supply.

SALBUTAMOL as the only therapeutically active substance:

(a) in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or

(b) in dry powders for inhalation delivering 200 micrograms or less of salbutamol per dose.

SALICYLIC ACID in preparations for dermal use except in preparations containing 40 per cent or less of salicylic acid.

SANTONIN.

SODIUM PHOSPHATE in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures.

SODIUM PICOSULFATE in preparations for oral use for bowel cleansing prior to diagnostic medical or surgical procedures.

SULFACETAMIDE in preparations for ophthalmic use containing 10 per cent or less of sulfacetamide.

TERBUTALINE as the only therapeutically active substance:

(a) in metered aerosols delivering 250 micrograms or less of terbutaline per metered dose; or

(b) in dry powders for inhalation delivering 500 micrograms or less of terbutaline per dose.

THEOPHYLLINE in liquid oral preparations containing 2 per cent or less of theophylline.

TIOCONAZOLE in preparations for vaginal use.

TRIAMCINOLONE for buccal use in preparations containing 0.1 per cent or less of triamcinolone in a pack of 5 g or less.

TRIMEPRAZINE:

(a) in solid oral preparations except when included in Schedule 2; or

(b) in liquid oral preparations containing 10 mg or less of trimeprazine per 5 mL,

TRIPROLIDINE in oral preparations except:

SCHEDULE 4

(Substances marked # are listed in Appendix D)

ABACAVIR.

ABATACEPT.

ABCIXIMAB.

ACAMPROSATE CALCIUM.

ACARBOSE.

ACEBUTOLOL.

ACEPROMAZINE.

ACETANILIDE and alkyl acetanilides (excluding when present as an excipient) for human therapeutic use.

ACETARSOL.

ACETAZOLAMIDE.

ACETOHEXAMIDE.

ACETYLCARBROMAL.

ACETYLCHOLINE.

ACETYLCYSTEINE except:

(b) in preparations for oral use when labelled with a recommended daily dose of 1 g or less of acetylcysteine.

ACETYLDIGITOXIN.

ACETYL ISOVALERYLTYLOSIN.

ACETYLMETHYLDIMETHYLOXIMIDOPHENYLHYDRAZINE.

ACETYLSTROPHANTHIDIN.

ACICLOVIR except in preparations containing 5 per cent or less of aciclovir for the treatment of herpes labialis in packs containing 10 g or less.

ACIPIMOX.

# ACITRETIN.

ACOKANTHERA OUABAIO.

ACOKANTHERA SCHIMPERI.

ACONITUM spp. except:

(b) in preparations for oral use in adults in packs containing 0.02 mg or less of total alkaloids; or

(c) in preparations for dermal use in adults containing 0.02 per cent or less of total alkaloids in packs containing 0.02 mg or less of total alkaloids.

ACRIVASTINE.

ADALIMUMAB.

ADAPALENE.

ADEFOVIR.

ADENOSINE for human therapeutic use in preparations for injection.

ADIPHENINE.

ADONIS VERNALIS.

ADRAFINIL.

ADRENALINE except:

(a) when included in Schedule 3; or

(b) in preparations containing 0.02 per cent or less of adrenaline.

ADRENOCORTICAL HORMONES except when separately specified in these Schedules.

AFAMELANOTIDE (Melanocyte stimulating hormone).

AGALSIDASE.

AGLEPRISTONE.

AGOMELATINE.

ALATROFLOXACIN MESYLATE.

ALBENDAZOLE except:

(b) in intraruminal implants each containing 3.85 g or less of albendazole for the treatment of animals.

ALCLOFENAC.

ALCLOMETASONE except when included in Schedule 3.

ALCURONIUM.

ALDESLEUKIN.

ALDOSTERONE.

ALEFACEPT.

ALEMTUZUMAB.

ALENDRONIC ACID.

ALFACALCIDOL.

ALFUZOSIN.

ALGLUCERASE.

ALGLUCOSIDASE.

ALISKIREN.

ALLERGENS.

ALLOPURINOL.

ALLYLOESTRENOL.

ALOSETRON.

ALPHA1-PROTEINASE INHIBITOR (HUMAN).

ALPHADOLONE.

ALPHAXALONE.

ALPRAZOLAM.

ALPRENOLOL.

ALPROSTADIL.

ALSEROXYLON.

ALTEPLASE.

ALTRENOGEST.

ALTRETAMINE (hexamethylmelamine).

AMANTADINE.

AMBENONIUM CHLORIDE.

# AMBRISENTAN.

AMBUCETAMIDE.

AMBUTONIUM BROMIDE.

AMCINONIDE.

AMETHOCAINE except:

(b) in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

AMIFOSTINE.

AMIKACIN.

AMILORIDE.

AMINOCAPROIC ACID.

AMINOGLUTETHIMIDE.

AMINOMETRADINE.

† AMINOPHENAZONE (amidopyrine) and derivatives for the treatment of animals.

AMINOPHYLLINE except when included in Schedule 3.

AMINOPTERIN.

4-AMINOPYRIDINE for therapeutic use.

AMINOREX.

AMINOSALICYLIC ACID.

AMIODARONE.

AMIPHENAZOLE.

AMISOMETRADINE.

AMISULPRIDE.

AMITRIPTYLINE.

AMLODIPINE.

AMMI VISNAGA.

AMMONIUM BROMIDE for therapeutic use.

AMODIAQUINE.

AMOROLFINE except:

AMOXAPINE.

AMOXYCILLIN.

AMPHOMYCIN.

AMPHOTERICIN.

AMPICILLIN.

AMPRENAVIR.

AMRINONE.

AMSACRINE.

AMYL NITRITE.

AMYLOBARBITONE when packed and labelled for injection.

AMYLOCAINE.

# ANABOLIC STEROIDAL AGENTS.

ANAGRELIDE.

ANAKINRA.

ANASTROZOLE.

ANCESTIM.

ANCROD and its immunoglobulin antidote.

ANECORTAVE.

# ANDROGENIC STEROIDAL AGENTS.

# ANDROISOXAZOLE.

# ANDROSTANOLONE.

# ANDROSTENEDIOL.

# ANDROSTENEDIONE.

ANGIOTENSIN AMIDE.

ANIDULAFUNGIN.

ANISTREPLASE.

ANTAZOLINE except when included in Schedule 2.

ANTIBIOTIC SUBSTANCES except:

(b) nisin.

ANTIGENS for human therapeutic use except when separately specified in this Schedule.

ANTIHISTAMINES except:

ANTIMONY for therapeutic use except when separately specified in these Schedules.

ANTISERA (immunosera) for human use by injection except when separately specified in these Schedules.

APOCYNUM spp.

APOMORPHINE.

APRACLONIDINE.

APRAMYCIN.

APREPITANT.

APRONAL.

APROTININ.

ARECOLINE.

ARIPIPRAZOLE.

ARSENIC for human therapeutic use except when separately specified in these Schedules.

ARTEMETHER.

ARTICAINE.

ASENAPINE.

ASPIRIN:

(a) when combined with caffeine, paracetamol or salicylamide or any derivative of these substances; or

(b) for injection.

ASTEMIZOLE.

# ATAMESTANE.

ATAZANAVIR.

ATENOLOL.

ATIPAMEZOLE.

A SCHEDULE 4 – continued

TOMOXETINE.

ATORVASTATIN.

ATOSIBAN.

ATOVAQUONE.

ATRACURIUM BESYLATE.

ATROPA BELLADONNA (belladonna) except when included in Schedule 2.

ATROPINE except when included in Schedule 2.

ATROPINE METHONITRATE.

AURANOFIN.

AUROTHIOMALATE SODIUM.

AVILAMYCIN except:

(a) in animal feed premixes containing 15 per cent or less of avilamycin activity; or

(b) in animal feeds containing 50 mg/kg or less of avilamycin activity.

AVIPTADIL.

AVOPARCIN.

AZACITIDINE.

AZACYCLONOL.

AZAPERONE.

AZAPROPAZONE.

AZARIBINE.

AZATADINE except when included in Schedule 3.

AZATHIOPRINE.

AZELAIC ACID except:

(b) in preparations containing 1 per cent or less of azelaic acid for non-human use.

AZELASTINE except when included in Schedule 2 or 3.

AZITHROMYCIN.

AZLOCILLIN.

AZTREONAM.

BACAMPICILLIN.

BACITRACIN.

BACLOFEN.

BALSALAZIDE.

BAMBERMYCIN (flavophospholipol) except:

(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.

BAMBUTEROL.

BAMETHAN.

BAMIPINE.

BARBITURATES except when separately specified in these Schedules.

BASILIXIMAB.

BAZEDOXIFENE.

BECAPLERMIN.

BECLAMIDE.

BECLOMETHASONE except when included in Schedule 2.

BELIMUMAB.

BEMEGRIDE.

BENACTYZINE.

BENAZEPRIL.

BENDROFLUAZIDE.

BENETHAMINE PENICILLIN.

BENORYLATE.

BENOXAPROFEN.

BENPERIDOL.

BENSERAZIDE.

BENZATHINE PENICILLIN.

BENZHEXOL.

BENZILONIUM.

BENZOCAINE except:

(b) in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or

(c) in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

BENZODIAZEPINE derivatives except when separately specified in these Schedules.

BENZOYL PEROXIDE in preparations for human therapeutic use except:

(b) in preparations for external use containing 5 per cent or less of benzoyl peroxide.

BENZPHETAMINE.

BENZTHIAZIDE.

BENZTROPINE (benzatropine).

BENZYDAMINE except:

(b) in preparations for dermal use.

BENZYLPENICILLIN.

BEPRIDIL.

BERACTANT.

BETAHISTINE.

BETAMETHASONE.

BETAXOLOL.

BETHANECHOL CHLORIDE.

BETHANIDINE.

BEVACIZUMAB.

BEVANTOLOL.

# BEXAROTENE.

BEZAFIBRATE.

BICALUTAMIDE.

BIFONAZOLE except:

(b) in preparations for dermal use containing 1 per cent or less of bifonazole for the treatment of the scalp; or

(c) in preparations for dermal use for the treatment of tinea pedis.

BIMATOPROST.

BIPERIDEN.

BISMUTH COMPOUNDS for cosmetic use, except:

(a) bismuth citrate when incorporated in hair colourant preparations in concentrations of 0.5 per cent or less; or

(b) bismuth oxychloride.

BISMUTH COMPOUNDS for human therapeutic use, except bismuth formic iodide or bismuth subiodide in

dusting powders containing 3 per cent or less of bismuth.

BISOPROLOL.

BIVALIRUDIN.

BLEOMYCIN.

# BOLANDIOL.

# BOLASTERONE.

# BOLAZINE.

# BOLDENONE (dehydrotestosterone).

# BOLENOL.

# BOLMANTALATE.

BORON, including boric acid and borax, for human therapeutic use except:

(a) in preparations for internal use containing 6 mg or less of boron per recommended daily dose;

(b) in preparations for dermal use containing 0.35 per cent or less of boron, which are not for paediatric or antifungal use; or

(c) when present as an excipient.

BORTEZOMIB.

# BOSENTAN.

BOTULINUM TOXINS for human use except when separately specified in

BRETYLIUM TOSYLATE.

BRIMONIDINE.

BRINZOLAMIDE.

BROMAZEPAM.

BROMIDES, inorganic, for therapeutic use except when separately specified in

BROMOCRIPTINE.

BROMOFORM for therapeutic use.

BROMPHENIRAMINE except when included in Schedule 2 or 3.

BROMVALETONE.

BRUGMANSIA spp.

BUCLIZINE except when included in Schedule 3.

BUDESONIDE except when included in Schedule 2.

BUFEXAMAC except:

(a) in preparations for dermal use containing 5 per cent or less of bufexamac; or

(b) in suppositories.

BUMETANIDE.

BUPHENINE.

BUPIVACAINE.

BUPROPION.

BUSERELIN.

BUSPIRONE.

BUSULPHAN.

BUTACAINE.

BUTOCONAZOLE except when included in Schedule 3.

BUTRACONAZOLE.

BUTYL AMINOBENZOATE except in dermal preparations containing 2 per cent or less of total local anaesthetic substances.

BUTYLCHLORAL HYDRATE.

BUTYL NITRITE.

CABERGOLINE.

CADMIUM COMPOUNDS for human therapeutic use.

CALCIPOTRIOL.

CALCITONIN.

CALCITRIOL.

CALCIUM CARBIMIDE for therapeutic use.

CALCIUM POLYSTYRENE SULPHONATE.

CALOTROPIS GIGANTEA.

CALOTROPIS PROCERA.

# CALUSTERONE.

CAMPHORATED OIL for therapeutic use.

CAMPHOTAMIDE.

CANDESARTAN CILEXETIL.

CANDICIDIN.

CANINE TICK ANTI-SERUM.

CANTHARIDIN.

CAPECITABINE.

CAPREOMYCIN.

CAPTODIAME.

CAPTOPRIL.

CAPURIDE.

CARAMIPHEN.

CARBACHOL.

CARBAMAZEPINE.

CARBARYL for human therapeutic use.

CARBAZOCHROME.

CARBENICILLIN.

CARBENOXOLONE for internal use.

CARBETOCIN.

CARBIDOPA.

CARBIMAZOLE.

CARBOCROMEN.

CARBOPLATIN.

CARBOPROST.

CARBROMAL.

CARBUTAMIDE.

CARBUTEROL.

CARINDACILLIN.

CARISOPRODOL.

CARMUSTINE.

CARNIDAZOLE.

CARPROFEN.

CARVEDILOL.

CASPOFUNGIN.

CATHINE.

CEFACETRILE.

CEFACLOR.

CEFADROXIL.

CEFALORIDINE.

CEFAMANDOLE.

CEFAPIRIN.

CEFAZOLIN.

CEFEPIME.

CEFETAMET.

CEFIXIME.

CEFODIZIME.

CEFONICID.

CEFOPERAZONE.

CEFOTAXIME.

CEFOTETAN.

CEFOTIAM.

CEFOVECIN for veterinary use.

CEFOXITIN.

CEFPIROME.

CEFPODOXIME.

CEFSULODIN.

CEFTAZIDIME.

CEFTIBUTEN.

CEFTIOFUR.

CEFTRIAXONE.

CEFUROXIME.

CELECOXIB.

CELIPROLOL.

CEPHAELIS ACUMINATA (ipecacuanha) except in preparations containing 0.2 per cent or less of emetine.

CEPHAELIS IPECACUANHA except in preparations containing 0.2 per cent or less of emetine.

CEPHALEXIN.

CEPHALONIUM.

CEPHALOTHIN.

CEPHRADINE.

CERIVASTATIN.

CERTOLIZUMAB PEGOL.

CERULETIDE.

CETIRIZINE except when included in Schedule 2.

CETRORELIX.

CETUXIMAB.

CHENODEOXYCHOLIC ACID.

CHLORAL FORMAMIDE.

CHLORAL HYDRATE except in preparations for topical use containing 2 per cent or less of chloral hydrate.

CHLORALOSE except when included in Schedule 6.

CHLORAMBUCIL.

CHLORAMPHENICOL except when included in Schedule 3.

# CHLORANDROSTENOLONE.

CHLORAZANIL.

CHLORCYCLIZINE.

CHLORDIAZEPOXIDE.

CHLORMERODRIN.

CHLORMETHIAZOLE.

CHLORMEZANONE.

CHLOROFORM for use in anaesthesia.

# 4-CHLOROMETHANDIENONE.

2-(4-CHLOROPHENYL)-(1,2,4)TRIAZOLO[5,1-A]ISOQUINOLINE.

CHLOROQUINE.

CHLOROTHIAZIDE.

CHLOROTRIANISENE.

# CHLOROXYDIENONE.

CHLORPHENIRAMINE except when included in Schedule 2 or 3.

CHLORPHENTERMINE.

CHLORPROMAZINE.

CHLORPROPAMIDE.

CHLORPROTHIXENE.

CHLORQUINALDOL for human topical use.

CHLORTETRACYCLINE except when included in Schedule 5.

CHLORTHALIDONE.

CHLORZOXAZONE.

CHOLERA VACCINE.

CHOLESTYRAMINE (colestyramine) for human therapeutic use.

CHYMOPAPAIN for human therapeutic use.

CICLACILLIN.

CICLESONIDE.

CICLOPIROX except when included in Schedule 2 or 3.

CIDOFOVIR.

CILASTATIN.

CILAZAPRIL.

CILOSTAZOL.

CIMETIDINE except when included in Schedule 3.

CINACALCET.

CINCHOCAINE except when included in Schedule 2.

CINOXACIN.

CIPROFLOXACIN.

CISAPRIDE.

CISATRACURIUM BESYLATE.

CISPLATIN.

CITALOPRAM.

CLADRIBINE.

CLANOBUTIN.

CLARITHROMYCIN.

CLAVULANIC ACID.

CLEMASTINE except when included in Schedule 3.

CLEMIZOLE.

CLENBUTEROL.

CLEVIDIPINE.

CLIDINIUM BROMIDE.

CLINDAMYCIN.

† CLIOQUINOL and other halogenated derivatives of 8-hydroxyquinoline for human topical use except when separately specified in this Schedule.

CLOBAZAM.

CLOBETASOL.

CLOBETASONE (clobetasone-17-butyrate) except when included in Schedule 3.

CLOCORTOLONE.

CLODRONIC ACID (includes sodium clodronate).

CLOFARABINE.

CLOFAZIMINE.

CLOFENAMIDE.

CLOFIBRATE.

# CLOMIPHENE.

CLOMIPRAMINE.

CLOMOCYCLINE.

CLONAZEPAM.

CLONIDINE.

CLOPAMIDE.

CLOPIDOGREL.

CLOPROSTENOL.

CLORAZEPATE.

CLOREXOLONE.

CLORPRENALINE.

# CLOSTEBOL (4-chlorotestosterone).

CLOTRIMAZOLE except:

CLOXACILLIN.

# CLOZAPINE.

COBALT for human therapeutic use except as dicobalt edetate in preparations for the treatment of cyanide poisoning.

CODEINE when compounded with one or more other therapeutically active substances:

(a) in divided preparations containing 30 mg or less of codeine per dosage unit; or

(b) in undivided preparations containing 1 per cent or less of codeine,

except when included in Schedule 2 or 3.

CO-DERGOCRINE.

COLASPASE.

COLCHICINE.

COLCHICUM AUTUMNALE.

COLESTIPOL.

COLFOSCERIL PALMITATE for human therapeutic use.

COLISTIN.

COLLAGEN in preparations for injection or implantation:

CONVALLARIA KEISKI.

CONVALLARIA MAJALIS.

COPPER COMPOUNDS for human use except:

(b) in preparations for human internal use containing 5 mg or less of copper per recommended daily dose; or

(c) in other preparations containing 5 per cent or less of copper compounds.

# CORIFOLLITROPIN ALFA.

CORONILLA spp.

CORTICOSTERONE.

CORTICOTROPHIN.

CORTISONE.

CO-TRIMOXAZOLE.

COUMARIN for therapeutic use (excluding when present as an excipient).

CRYSTAL VIOLET for human use except when used as a dermal marker.

CUPRIMYXIN.

CURARE.

CYCLANDELATE.

CYCLIZINE except when included in Schedule 3.

CYCLOBENZAPRINE.

# CYCLOFENIL.

CYCLOHEXIMIDE.

CYCLOPENTHIAZIDE.

CYCLOPENTOLATE.

CYCLOPHOSPHAMIDE.

CYCLOPROPANE for therapeutic use.

CYCLOSERINE.

CYCLOSPORIN.

CYCLOTHIAZIDE.

CYCRIMINE.

CYMARIN.

CYPROHEPTADINE except when included in Schedule 3.

CYPROTERONE.

CYSTEAMINE for human therapeutic use.

CYTARABINE.

DABIGATRAN.

DACARBAZINE.

DACLIZUMAB.

DACTINOMYCIN.

DALFOPRISTIN.

DALTEPARIN (includes dalteparin sodium).

DANAPAROID (includes danaparoid sodium).

# DANAZOL.

DANTHRON for human use.

DANTROLENE.

DAPOXETINE.

DAPSONE.

DAPTOMYCIN.

# DARBEPOETIN.

DARIFENACIN.

DARUNAVIR.

DATURA spp. except:

DASATINIB.

DATURA STRAMONIUM (stramonium) except:

(b) for smoking or burning.

DATURA TATULA (stramonium) except:

(b) for smoking or burning.

DAUNORUBICIN.

DEANOL.

DEBRISOQUINE.

DECAMETHONIUM.

DEFERASIROX.

DEFERIPRONE.

DEFLAZACORT.

DEGARELIX.

# DEHYDROCHLOROMETHYLTESTOSTERONE.

DEHYDROCORTICOSTERONE.

DELAVIRDINE (includes delavirdine mesylate).

DEMBREXINE except when included in Schedule 5.

DEMECARIUM.

DEMECLOCYCLINE.

DENOSUMAB.

DEOXYCORTONE.

DEOXYRIBONUCLEASE except:

(a) when separately specified in this Schedule; or

(b) for external use.

DERACOXIB.

DESFERRIOXAMINE.

DESFLURANE.

DESIPRAMINE.

DESIRUDIN.

DESLANOSIDE.

DESLORATADINE except when included in Schedule 2.

DESLORELIN.

DESMOPRESSIN (D.D.A.V.P.).

DESOGESTREL.

DESONIDE.

DESOXYMETHASONE.

DESVENLAFAXINE.

DETOMIDINE.

DEXAMETHASONE.

DEXCHLORPHENIRAMINE except when included in Schedule 2 or 3.

DEXFENFLURAMINE.

DEXMEDETOMIDINE.

DEXTROMETHORPHAN (excluding its stereoisomers) except when included in Schedule 2.

# DEXTROPROPOXYPHENE:

(a) in divided preparations containing 135 mg of dextropropoxyphene or less per dosage unit; or

(b) liquid preparations containing 2.5 per cent or less of dextropropoxyphene.

DEXTRORPHAN (excluding its stereoisomers).

DIAMTHAZOLE.

DIAVERIDINE.

DIAZEPAM.

DIAZOXIDE.

DIBENZEPIN.

DIBOTERMIN.

DIBROMOPROPAMIDINE for therapeutic use except when included in Schedule 2.

DICHLORALPHENAZONE.

DICHLOROPHEN for human therapeutic use.

DICHLORPHENAMIDE.

DICLOFENAC except:

(b) in preparations for dermal use unless:

(i) for the treatment of solar keratosis; or

(ii) containing more than 1 per cent of diclofenac.

DICLOXACILLIN.

DICYCLOMINE.

DIDANOSINE.

DIENESTROL.

DIENOGEST.

DIETHAZINE.

DIETHYLCARBAMAZINE for human therapeutic use.

DIETHYLPROPION.

DIFENOXIN in preparations containing, per dosage unit, 0.5 mg or less of difenoxin and a quantity of atropine sulfate equivalent to at least 5 per cent of the dose of difenoxin.

DIFLORASONE.

DIFLOXACIN.

DIFLUCORTOLONE.

DIFLUNISAL.

DIGITALIS LANATA.

DIGITALIS PURPUREA.

DIGITOXIN.

DIGOXIN.

DIGOXIN-SPECIFIC ANTIBODY FRAGMENT F (Ab).

DIHYDRALAZINE.

DIHYDROCODEINE when compounded with one or more other therapeutically
active substances:

(a) in divided preparations containing not more than 100 mg of dihydrocodeine per dosage unit; or

(b) in undivided preparations with a concentration of not more than
2.5 per cent of dihydrocodeine,

except when included in Schedule 2 or 3.

DIHYDROERGOTOXINE.

# DIHYDROLONE.

DIHYDROSTREPTOMYCIN.

DIHYDROTACHYSTEROL.

† DI-IODOHYDROXYQUINOLINE (iodoquinol) except:

(a) when included in Schedule 3; or

(b) for human internal use.

DIISOPROPYLAMINE DICHLOROACETATE.

DILTIAZEM.

DIMENHYDRINATE except when included in Schedule 2 or 3.

DIMERCAPROL.

# DIMETHANDROSTANOLONE.

# DIMETHAZINE.

DIMETHINDENE except when included in Schedule 3.

DIMETHOTHIAZINE.

DIMETHOXANATE.

DIMETHYL SULFOXIDE for therapeutic use except:

(b) in in vitro test kits.

DIMETRIDAZOLE.

2,4-DINITROCHLOROBENZENE for therapeutic use.

DINITROCRESOLS for therapeutic use except when separately specified in

DINITRONAPHTHOLS for therapeutic use except when separately specified in these Schedules.

DINITROPHENOLS for therapeutic use.

DINITROTHYMOLS for therapeutic use except when separately specified in these Schedules.

# DINOPROST.

# DINOPROSTONE.

DIPERODON.

DIPHEMANIL except in preparations for dermal use.

DIPHENHYDRAMINE except when included in Schedule 2 or 3.

DIPHENIDOL.

DIPHENOXYLATE in preparations containing, per dosage unit, 2.5 mg or less of diphenoxylate and a quantity of atropine sulfate equivalent to at least 1 per cent of the dose of diphenoxylate except when included in Schedule 3.

DIPHENYLPYRALINE.

DIPHTHERIA TOXOID.

DIPIVEFRIN.

DIPYRIDAMOLE.

DIRITHROMYCIN.

DIRLOTAPIDE.

DISOPHENOL.

DISOPYRAMIDE.

DISTIGMINE.

DISULFIRAM for therapeutic use.

DISULPHAMIDE.

DITHIAZANINE except when included in Schedule 6.

DITIOCARB.

DOBUTAMINE.

DOCETAXEL.

DOFETILIDE.

DOLASETRON.

DOMPERIDONE.

DONEPEZIL.

DOPAMINE.

DOPEXAMINE.

DORIPENEM.

DORNASE.

DORZOLAMIDE.

DOTHIEPIN.

DOXANTRAZOLE.

DOXAPRAM.

DOXAZOSIN.

DOXEPIN.

DOXORUBICIN.

DOXYCYCLINE.

DOXYLAMINE except when included in Schedule 2 or 3.

DRONEDARONE.

DROPERIDOL.

DROSPIRENONE.

# DROSTANOLONE.

DROTRECOGIN.

DUBOISIA LEICHHARDTII except when included in Schedule 2.

DUBOISIA MYOPOROIDES except when included in Schedule 2.

DULOXETINE.

DUTASTERIDE.

DYDROGESTERONE.

ECONAZOLE except:

ECOTHIOPATE (includes ecothiopate iodide).

ECTYLUREA.

EDETIC ACID for human therapeutic use except:

(a) in preparations containing 0.25 per cent or less of edetic acid;

(b) as dicobalt edetate in preparations for the treatment of cyanide poisoning; or

(c) in contact lens preparations.

EDOXUDINE.

EDROPHONIUM.

EFALIZUMAB.

EFAVIRENZ.

EFLORNITHINE.

ELETRIPTAN.

ELTENAC.

ELTROMBOPAG.

EMEPRONIUM.

EMETINE except in preparations containing 0.2 per cent or less of emetine.

EMTRICITABINE.

ENALAPRIL.

# ENESTEBOL.

ENFLURANE for therapeutic use.

ENFUVIRTIDE.

ENOXACIN.

ENOXAPARIN.

ENOXIMONE.

ENPROSTIL.

ENROFLOXACIN.

ENTACAPONE.

ENTECAVIR.

EPHEDRA spp. except in preparations containing 0.001 per cent or less of ephedrine.

# EPHEDRINE.

EPICILLIN.

EPINASTINE.

EPIRUBICIN.

# EPITIOSTANOL.

EPLERENONE.

# EPOETINS.

EPOPROSTENOL.

EPROSARTAN.

EPTIFIBATIDE.

ERGOMETRINE.

ERGOT.

ERGOTAMINE.

ERGOTOXINE.

ERLOTINIB.

ERTAPENEM.

ERYSIMUM spp.

ERYTHROMYCIN.

# ERYTHROPOIETIN.

# ERYTHROPOIETINS except when separately specified in these Schedules.

ESCITALOPRAM.

ESMOLOL.

ESOMEPRAZOLE.

ESTRAMUSTINE.

ESTROPIPATE (piperazine oestrone sulfate).

ETANERCEPT.

ETHACRYNIC ACID.

ETHAMBUTOL.

ETHAMIVAN.

ETHANOLAMINE in preparations for injection.

ETHCHLORVYNOL.

ETHER for use in anaesthesia.

ETHINAMATE.

ETHINYLOESTRADIOL.

ETHIONAMIDE.

ETHISTERONE.

ETHOGLUCID.

ETHOHEPTAZINE.

ETHOPROPAZINE.

ETHOSUXIMIDE.

ETHOTOIN.

ETHOXZOLAMIDE.

ETHYL CHLORIDE for human therapeutic use.

# ETHYLDIENOLONE.

† ETHYLHEXANEDIOL for animal use.

ETHYLMORPHINE when compounded with one or more other therapeutically active substances:

(a) in divided preparations containing not more than 100 mg of ethylmorphine per dosage unit; or

(b) in undivided preparations with a concentration of not more than 2.5 per cent of ethylmorphine,

# ETHYLOESTRENOL.

ETHYNODIOL.

ETIDOCAINE.

ETIDRONIC ACID (includes disodium etidronate):

(b) in topical preparations except in preparations containing 1 per cent or less of etidronic acid.

ETILEFRIN.

ETIPROSTON.

ETODOLAC.

ETOFENAMATE except when included in Schedule 2.

ETONOGESTREL.

ETOPOSIDE.

ETORICOXIB.

ETRAVIRINE.

# ETRETINATE.

EVEROLIMUS.

EXEMESTANE.

EXENATIDE.

EZETIMIBE.

FAMCICLOVIR.

FAMOTIDINE except when included in Schedule 2.

FELBINAC except when included in Schedule 2.

FELODIPINE.

FELYPRESSIN.

FENBUFEN.

FENCAMFAMIN.

FENCLOFENAC.

FENFLURAMINE.

FENOFIBRATE.

FENOLDOPAM.

FENOPROFEN.

FENOTEROL.

FENPIPRAMIDE.

FENPIPRANE.

FENPROPOREX.

FENPROSTALENE.

FEXOFENADINE except when included in Schedule 2.

FIBRINOLYSIN except for external use.

FILGRASTIM.

FINASTERIDE.

FIROCOXIB.

FLECAINIDE.

FLEROXACIN.

FLOCTAFENINE.

FLORFENICOL.

FLUANISONE.

FLUCLOROLONE.

FLUCLOXACILLIN.

FLUCONAZOLE except when included in Schedule 3.

FLUCYTOSINE.

FLUDARABINE.

FLUDROCORTISONE.

FLUFENAMIC ACID.

FLUMAZENIL.

FLUMETHASONE.

FLUMETHIAZIDE.

FLUNISOLIDE.

FLUNIXIN MEGLUMINE.

FLUOCINOLONE.

FLUOCINONIDE.

FLUOCORTIN.

FLUOCORTOLONE.

FLUORESCEIN in preparations for injection.

FLUORIDES in preparations for human use except when included in or expressly excluded from Schedule 2 or 3.

FLUOROMETHOLONE.

FLUOROURACIL.

FLUOXETINE.

# FLUOXYMESTERONE.

FLUPENTHIXOL.

FLUPHENAZINE.

FLUPROSTENOL.

FLURANDRENOLONE.

FLURAZEPAM.

FLURBIPROFEN except when included in Schedule 2.

FLUROXENE for human therapeutic use.

FLUSPIRILENE.

FLUTAMIDE.

FLUTICASONE except when included in Schedule 2.

FLUVASTATIN.

FLUVOXAMINE.

FOLIC ACID in preparations for human use for injection.

FOLINIC ACID in preparations for human use for injection.

FOLLICLE-STIMULATING HORMONE except when separately specified in this Schedule.

# FOLLITROPIN ALPHA.

# FOLLITROPIN BETA.

FOMIVIRSEN.

FONDAPARINUX.

# FORMEBOLONE.

FORMESTANE.

FORMOTEROL.

FOSAMPRENAVIR.

FOSAPREPITANT.

FOSCARNET.

FOSFESTROL (diethylstilboestrol diphosphate).

FOSINOPRIL.

FOSPHENYTOIN.

FOTEMUSTINE.

FRAMYCETIN.

FULVESTRANT.

FURALTADONE.

# FURAZABOL.

FURAZOLIDONE.

FUROSEMIDE (frusemide).

FUSIDIC ACID.

GABAPENTIN.

GALANTAMINE.

GALANTHUS spp.

GALLAMINE.

GALSULFASE.

GANCICLOVIR.

GANIRELIX.

GATIFLOXACIN.

GEFITINIB.

GEMCITABINE.

GEMEPROST.

GEMFIBROZIL.

GEMIFLOXACIN.

GEMTUZUMAB OZOGAMICIN.

GENTAMICIN.

GESTODENE.

GESTONORONE.

GESTRINONE.

GHRH INJECTABLE PLASMID.

GITALIN.

GLATIRAMER ACETATE.

GLIBENCLAMIDE.

GLIBORNURIDE.

GLICLAZIDE.

GLIMEPIRIDE.

GLIPIZIDE.

GLISOXEPIDE.

GLUTATHIONE for parenteral use.

# GLUTETHIMIDE.

GLYCERYL TRINITRATE except when included in Schedule 3.

GLYCOPYRRONIUM in preparations for injection.

GLYMIDINE.

GnRH VACCINE.

GOLIMUMAB.

GONADORELIN.

GONADOTROPHIC HORMONES except when separately specified in this Schedule.

GOSERELIN.

GRAMICIDIN.

GRANISETRON.

GREPAFLOXACIN.

GRISEOFULVIN.

GUAIPHENESIN for human therapeutic use except:

(b) in oral liquid preparations containing 2 per cent or less of guaiphenesin; or

(c) in divided preparations containing 200 mg or less of guaiphenesin per dosage unit.

GUANABENZ.

GUANACLINE.

GUANETHIDINE.

GUANIDINE for therapeutic use.

HACHIMYCIN.

HAEMATIN.

HAEMOPHILUS INFLUENZAE VACCINE.

HALCINONIDE.

HALOFANTRINE.

HALOFENATE.

HALOFUGINONE in preparations containing 0.1 per cent or less of halofuginone for the treatment of animals.

HALOPERIDOL.

HALOTHANE for therapeutic use.

HEMEROCALLIS (Hemerocallis flava).

HEPARINS for internal use except when separately specified in this Schedule.

HEPATITIS A VACCINE.

HEPATITIS B VACCINE.

HETACILLIN.

HEXACHLOROPHANE:

(a) in preparations for use on infants; or

(b) in other preparations except:

(i) when included in Schedule 2 or 6; or

(ii) in preparations containing 0.75 per cent or less of hexachlorophane.

HEXAMETHONIUM.

HEXETIDINE for human internal use.

HEXOBENDINE.

HEXOCYCLIUM.

HEXOPRENALINE.

HISTAMINE for therapeutic use except in preparations containing 0.5 per cent or less of histamine.

HMG-CoA REDUCTASE INHIBITORS (including "statins") except when separately specified in these Schedules.

HOMATROPINE.

HUMAN CHORIONIC GONADATROPHIN except in pregnancy test kits.

HUMAN PAPILLOMAVIRUS VACCINE.

HYALURONIC ACID AND ITS POLYMERS in preparations for injection or implantation:

(a) for tissue augmentation;

(b) for cosmetic use; or

(c) for the treatment of animals.

HYDRALAZINE.

HYDRARGAPHEN.

HYDROCHLOROTHIAZIDE.

HYDROCORTISONE:

(a) for human use except when included in Schedule 2 or 3; or

(b) for the treatment of animals.

HYDROCYANIC ACID for therapeutic use.

HYDROFLUMETHIAZIDE.

HYDROQUINONE (other than its alkyl ethers separately specified in this Schedule) in preparations for human therapeutic or cosmetic use except:

(b) in hair preparations containing 0.3 per cent or less of hydroquinone.

HYDROXYCHLOROQUINE.

HYDROXYEPHEDRINE.

HYDROXYPHENAMATE.

HYDROXYPROGESTERONE.

# HYDROXYSTENOZOL.

HYDROXYUREA.

HYDROXYZINE.

HYGROMYCIN.

HYOSCINE except when included in Schedule 2.

HYOSCYAMINE except when included in Schedule 2.

HYOSCYAMUS NIGER except:

(b) in a pack containing 0.03 mg or less of total solanaceous alkaloids.

HYPOTHALAMIC RELEASING FACTORS except when separately specified in this Schedule.

HYPROMELLOSE in preparations for injection.

IBAFLOXACIN for veterinary use.

IBANDRONIC ACID.

IBOGAINE.

IBRITUMOMAB.

IBUFENAC.

IBUPROFEN except:

(a) when included in or expressly excluded from Schedule 2 or 3; or

(b) in preparations for dermal use.

IBUTEROL.

IBUTILIDE.

ICATIBANT.

IDARUBICIN.

IDOXURIDINE except in preparations containing 0.5 per cent or less of idoxuridine for dermal use.

IDURSULFASE.

IFOSFAMIDE.

ILOPROST.

IMATINIB.

IMIDAPRIL.

IMIGLUCERASE.

IMIPENEM.

IMIPRAMINE.

IMIQUIMOD.

IMMUNOGLOBULINS for human parenteral use except when separately specified in these Schedules.

INDACATEROL.

INDAPAMIDE.

INDINAVIR.

INDOMETHACIN except when included in Schedule 2.

INDOPROFEN.

INDORAMIN.

INFLIXIMAB.

INFLUENZA AND CORYZA VACCINES:

(a) for parenteral use; or

(b) for nasal administration.

# INSULIN-LIKE GROWTH FACTOR I.

# INSULIN-LIKE GROWTH FACTORS except when separately specified in this Schedule.

INSULINS.

INTERFERONS.

INTERLEUKINS except when separately specified in these Schedules.

IODOTHIOURACIL.

IPRATROPIUM except when included in Schedule 2.

IPRIFLAVONE.

IPRINDOLE.

IPRONIAZID.

IRBESARTAN.

IRINOTECAN.

IRON COMPOUNDS in injectable preparations for human use.

ISOAMINILE.

ISOAMYL NITRITE.

ISOBUTYL NITRITE.

ISOCARBOXAZID.

ISOCONAZOLE except when included in Schedule 2, 3 or 6.

ISOETARINE.

ISOFLURANE for therapeutic use.

ISOMETHEPTENE.

ISONIAZID.

ISOPRENALINE.

ISOPRINOSINE.

ISOPROPAMIDE except when included in Schedule 2.

ISOSORBIDE DINITRATE except when included in Schedule 3.

ISOSORBIDE MONONITRATE.

# ISOTRETINOIN.

ISOXICAM.

ISOXSUPRINE.

ISRADIPINE.

ITRACONAZOLE.

IVABRADINE.

IVERMECTIN:

(a) for human use; or

(b) for the treatment of mange in dogs.

IXABEPILONE.

JAPANESE ENCEPHALITIS VACCINE.

KANAMYCIN.

KETANSERIN except in topical veterinary preparations containing 0.5 per cent
or less of ketanserin.

KETAZOLAM.

KETOCONAZOLE except:

(b) in preparations for dermal use containing 1 per cent or less of ketoconazole for the treatment of the scalp; or

(c) in preparations for dermal use for the treatment of tinea pedis.

KETOPROFEN except:

(a) in preparations for dermal use; or

(b) when included in Schedule 3.

KETOROLAC (includes ketoralac trometamol).

KETOTIFEN except when included in Schedule 2.

KHELLIN.

KITASAMYCIN except:

(a) when included in Schedule 5 ; or

(b) in animal feeds for growth promotion containing 100 mg/kg or less of antibiotic substances.

LABETALOL.

LACIDIPINE.

LACOSAMIDE.

LAMIVUDINE.

LAMOTRIGINE.

LANATOSIDES.

LANREOTIDE.

LANSOPRAZOLE except when included in Schedule 3.

LANTHANUM for therapeutic use.

LAPATINIB.

LARONIDASE.

LAROPIPRANT.

LATAMOXEF.

LATANOPROST.

LAUDEXIUM.

LAUROMACROGOLS in preparations for injection except:

(a) when present as an excipient; or

† LEAD for human therapeutic use.

LEFETAMINE.

LEFLUNOMIDE.

# LENALIDOMIDE.

LENOGRASTIM.

LEPIRUDIN.

LEPTAZOL.

LERCANIDIPINE.

LETROZOLE.

LEUPRORELIN.

LEVALLORPHAN.

LEVAMISOLE:

(a) for human therapeutic use; or

(b) in preparations for the prevention or treatment of heartworm in dogs.

LEVETIRACETAM.

LEVOBUNOLOL.

LEVOBUPIVACAINE.

LEVOCABASTINE except when included in Schedule 2.

LEVODOPA.

LEVOMEPROMAZINE.

LEVONORGESTREL except when included in Schedule 3.

LEVOSIMENDAN.

LIDOFLAZINE.

LIGNOCAINE except:

(b) in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or

(c) in lozenges containing 30 mg or less of total local anaesthetic substances per dosage unit.

LINAGLIPTIN.

LINCOMYCIN.

LINDANE for human therapeutic use except when included in Schedule 2.

LINEZOLID.

LIOTHYRONINE.

LIRAGLUTIDE.

LISINOPRIL.

LISURIDE.

LITHIUM for therapeutic use except:

(b) when present as an excipient in preparations for dermal use containing 0.25 per cent or less of lithium; or

(c) in preparations containing 0.01 per cent or less of lithium.

LODOXAMIDE except when included in Schedule 2.

LOFEXIDINE.

LOGIPARIN for internal use.

LOMEFLOXACIN.

LOMUSTINE.

LOPERAMIDE except when included in Schedule 2.

LOPINAVIR.

LOPRAZOLAM.

LORACARBEF.

LORATADINE except when included in Schedule 2.

LORAZEPAM.

LORMETAZEPAM.

LOSARTAN.

LOXAPINE.

LUMEFANTRINE.

LUMIRACOXIB.

# LUTEINISING HORMONE except in ovulation test kits.

LYMECYCLINE.

MAFENIDE except when included in Schedule 6.

MANDRAGORA OFFICINARUM.

MANNOMUSTINE.

MAPROTILINE.

MARAVIROC.

MARBOFLOXACIN.

MAROPITANT.

MAZINDOL.

MEASLES VACCINE.

MEBANAZINE.

MEBEVERINE.

MEBHYDROLIN.

# MEBOLAZINE.

MEBUTAMATE.

MECAMYLAMINE.

MECASERMIN.

MECILLINAM.

MECLOCYCLINE.

MECLOFENAMATE.

MECLOFENOXATE.

MECLOZINE except when included in Schedule 2.

MEDAZEPAM.

MEDETOMIDINE.

MEDIGOXIN (methyldigoxin).

MEDROXYPROGESTERONE.

MEDRYSONE.

MEFENAMIC ACID except when included in Schedule 2.

MEFENOREX.

MEFLOQUINE.

MEFRUSIDE.

MEGESTROL.

MELAGATRAN.

MELATONIN for human use.

MELENGESTROL except when included in Schedule 6.

MELOXICAM.

MELPHALAN.

MEMANTINE.

MENINGOCOCCAL VACCINE.

MENOTROPHIN.

MEPACRINE.

MEPENZOLATE.

MEPHENESIN.

MEPHENTERMINE.

MEPINDOLOL.

# MEPITIOSTANE.

MEPIVACAINE.

MEPROBAMATE.

MEPTAZINOL.

MEPYRAMINE except when included in Schedule 2 or 3.

MEQUITAZINE.

MERCAPTOMERIN.

MERCAPTOPURINE.

MERCUROCHROME except when included in Schedule 2 or 6.

MERCURY for cosmetic or therapeutic use except:

(b) in a sealed device which prevents access to the mercury.

MEROPENEM.

MERSALYL.

# MESABOLONE.

MESALAZINE.

MESNA.

# MESTANOLONE (androstalone).

# MESTEROLONE.

MESTRANOL.

# METANDIENONE.

METARAMINOL.

# METENOLONE.

METERGOLINE.

METFORMIN.

METHACHOLINE.

METHACYCLINE.

METHALLENOESTRIL.

# METHANDRIOL.

METHANTHELINIUM.

METHAZOLAMIDE.

METHDILAZINE except when included in Schedule 3.

# METHENOLONE.

METHICILLIN.

METHIMAZOLE.

METHISAZONE.

METHIXENE.

METHOCARBAMOL.

METHOHEXITONE.

METHOIN.

METHOTREXATE.

METHOXAMINE except:

(b) in preparations for external use containing 1 per cent or less of methoxamine.

METHOXSALEN.

METHOXYFLURANE.

METHSUXIMIDE.

METHYCLOTHIAZIDE.

METHYL AMINOLEVULINATE.

#METHYLANDROSTANOLONE.

# METHYLCLOSTEBOL.

METHYLDOPA.

METHYLENE BLUE in preparations for injection.

METHYLERGOMETRINE.

METHYL MERCURY for therapeutic use.

METHYLNALTREXONE.

METHYLPENTYNOL.

METHYLPHENOBARBITONE.

METHYLPREDNISOLONE.

METHYL SALICYLATE in preparations for internal therapeutic use.

# METHYLTESTOSTERONE.

METHYLTHIOURACIL.

# METHYLTRIENOLONE.

METHYPRYLONE.

METHYSERGIDE.

METOCLOPRAMIDE except when included in Schedule 3.

METOLAZONE.

METOPROLOL.

# METRIBOLONE.

METRIFONATE (trichlorfon) for human therapeutic use.

METRONIDAZOLE.

METYRAPONE.

MEXILETINE.

MEZLOCILLIN.

MIANSERIN.

MIBEFRADIL.

# MIBOLERONE.

MICONAZOLE except:

MIDAZOLAM.

MIDODRINE.

MIFEPRISTONE.

MIGLITOL.

MIGLUSTAT.

MILBEMYCIN OXIME except when included in Schedule 5.

MILRINONE.

MINOCYCLINE.

MINOXIDIL except when included in Schedule 2.

MIRTAZAPINE.

MISOPROSTOL.

MITOBRONITOL.

MITOMYCIN.

MITOTANE.

MITOXANTRONE.

MITRATAPIDE.

MIVACURIUM CHLORIDE.

MOCLOBEMIDE.

MODAFINIL.

MOLGRAMOSTIM.

MOLINDONE.

MOMETASONE except when included in Schedule 2.

MONENSIN except:

(b) in animal feeds containing 360 mg/kg or less of antibiotic substances.

MONOBENZONE and other alkyl ethers of hydroquinone for human therapeutic use or cosmetic use.

MONOCLONAL ANTIBODIES for therapeutic use except:

(a) in diagnostic test kits; or

MONTELUKAST.

MOPERONE.

MORAZONE.

MORICIZINE.

MOTRAZEPAM.

MOTRETINIDE.

MOXIDECTIN in preparations for injection containing 10 per cent or less of moxidectin except when included in Schedule 5.

MOXIFLOXACIN.

MOXONIDINE.

MUMPS VACCINE.

MUPIROCIN.

MURAGLITAZAR.

MUROMONAB.

MUSTINE (nitrogen mustard).

MYCOPHENOLIC ACID (includes mycophenolate mofetil).

NABUMETONE.

NADOLOL.

NADROPARIN.

NAFARELIN.

NAFTIDROFURYL.

NALBUPHINE.

NALIDIXIC ACID.

NALORPHINE.

NALOXONE.

NALTREXONE.

# NANDROLONE.

NAPROXEN except when included in Schedule 2.

NARASIN except:

(b) in animal feeds containing 100 mg/kg or less of antibiotic substances.

NARATRIPTAN.

NATALIZUMAB.

NATAMYCIN except for use as a food additive.

NATEGLINIDE.

NEBACUMAB.

NEBIVOLOL.

NEDOCROMIL.

NEFAZODONE.

NEFOPAM.

NELFINAVIR (includes nelfinavir mesylate).

NEOMYCIN.

NEOSTIGMINE.

NEPAFENAC.

NERIUM OLEANDER.

NESIRITIDE.

NETILMICIN.

NEVIRAPINE.

NIALAMIDE.

NICARDIPINE.

NICERGOLINE.

NICOFURANOSE.

NICORANDIL.

NICOTINE in preparations for human therapeutic use except:

(b) for use as an aid in withdrawal from tobacco smoking in chewing gum, lozenges, or preparations for sublingual, transdermal or oromucosal spray use.

NICOTINIC ACID for human therapeutic use except:

(b) in preparations containing 100 mg or less of nicotinic acid per dosage unit; or

(c) nicotinamide.

NICOUMALONE.

NIFEDIPINE.

NIFENAZONE.

NIKETHAMIDE.

NILOTINIB.

NILUTAMIDE.

NIMESULIDE.

NIMODIPINE.

NIMORAZOLE.

NIRIDAZOLE.

NISOLDIPINE.

NITISINONE.

NITRAZEPAM.

NITRENDIPINE.

NITRIC OXIDE for human therapeutic use.

NITROFURANTOIN.

NITROFURAZONE.

NITROUS OXIDE for therapeutic use.

NITROXOLINE.

NIZATIDINE except when included in Schedule 2.

NOMEGESTROL.

NOMIFENSINE.

NORADRENALINE.

# 19-NORANDROSTENEDIOL.

# 19-NORANDROSTENEDIONE.

# NORANDROSTENOLONE.

# NORBOLETHONE.

# NORCLOSTEBOL.

NORELGESTROMIN.

# NORETHANDROLONE.

NORETHISTERONE.

NORFLOXACIN.

NORGESTREL.

NORIBOGAINE.

# NORMETHANDRONE.

NORTRIPTYLINE.

NOVOBIOCIN.

NOXIPTYLINE.

NYSTATIN except when included in Schedule 2 or 3.

OCTAMYLAMINE.

OCTATROPINE.

OCTREOTIDE.

OCTYL NITRITE.

OESTRADIOL except when included in Schedule 5.

OESTRIOL.

OESTROGENS except when separately specified in these Schedules.

OESTRONE.

OFATUMUMAB.

OFLOXACIN.

OLANZAPINE.

OLEANDOMYCIN except:

(b) in animal feeds for growth promotion containing 50 mg/kg or less of antibiotic substances.

OLEANDRIN.

OLMESARTAN.

OLOPATADINE.

OLSALAZINE.

OMALIZUMAB.

OMEGA-3-ACID ETHYL ESTERS (excluding salts and derivatives) for human therapeutic use, for the treatment of post-myocardial infarction and / or hypertriglyceridaemia.

OMEPRAZOLE except when included in Schedule 3.

ONDANSETRON.

OPIPRAMOL.

ORBIFLOXACIN.

ORCIPRENALINE.

ORGANOPHOSPHORUS COMPOUNDS with anticholinesterase activity for human therapeutic use except:

(b) in preparations containing 2 per cent or less of malathion for external use.

ORLISTAT except when included in Schedule 3.

ORNIDAZOLE.

ORNIPRESSIN.

ORPHENADRINE.

ORTHOPTERIN.

OSELTAMIVIR.

OUABAIN.

# OVANDROTONE.

# OXABOLONE.

OXACILLIN.

OXALIPLATIN.

# OXANDROLONE.

OXAPROZIN.

OXAZEPAM.

OXCARBAZEPINE.

OXEDRINE for human internal use except in preparations labelled with a recommended daily dose of 30 mg or less of oxedrine.

OXETACAINE (oxethazaine) except when included in Schedule 2.

OXICONAZOLE except:

OXITROPIUM.

OXOLAMINE.

OXOLINIC ACID.

OXPENTIFYLLINE (pentoxifylline).

OXPRENOLOL.

OXYBUPROCAINE.

OXYBUTYNIN.

# OXYMESTERONE.

# OXYMETHOLONE.

OXYPHENBUTAZONE.

OXYPHENCYCLIMINE.

OXYPHENONIUM.

OXYTETRACYCLINE except when included in Schedule 5.

OXYTOCIN.

PACLITAXEL.

PALIFERMIN.

PALIPERIDONE.

PALIVIZUMAB.

PALONOSETRON.

PAMAQUIN.

PAMIDRONIC ACID (includes disodium pamidronate).

PANCREATIC ENZYMES except:

(a) in preparations containing 20,000 BP units or less of lipase activity per dosage unit; or

PANCURONIUM.

PANITUMUMAB.

PANTOPRAZOLE except when included in Schedule 3.

PAPAVERINE in preparations for injection.

PARACETAMOL:

(a) when combined with aspirin or salicylamide or any derivative of these substances except when separately specified in these Schedules;

(b) in slow release tablets or capsules containing more than 665 mg of paracetamol;

(c) in non-slow release tablets or capsules containing more than 500 mg of paracetamol;

(d) in individually wrapped powders or sachets of granules each containing more than 1000 mg of paracetamol; or

(e) for injection.

PARALDEHYDE.

PARAMETHADIONE.

PARAMETHASONE.

PARECOXIB.

PARICALCITOL.

PAROMOMYCIN.

PAROXETINE.

PAZOPANIB.

PECAZINE.

PEFLOXACIN.

PEGAPTANIB.

PEGFILGRASTIM.

PEGINTERFERON.

PEGVISOMANT.

PEMETREXED.

PEMOLINE.

PEMPIDINE.

PENBUTOLOL.

PENCICLOVIR except when included in Schedule 2.

PENETHAMATE.

PENICILLAMINE.

PENTAERYTHRITYL TETRANITRATE.

PENTAGASTRIN.

PENTAMETHONIUM.

PENTAMIDINE (includes pentamidine isethionate).

PENTHIENATE.

PENTOBARBITONE when packed and labelled for injection.

PENTOLINIUM.

PENTOSAN POLYSULFATE SODIUM.

PERGOLIDE.

PERHEXILINE.

PERICYAZINE.

PERINDOPRIL.

PERMETHRIN for human therapeutic use except in preparations containing 5 per cent or less of permethrin.

PERPHENAZINE.

PERTUSSIS ANTIGEN.

PHENACEMIDE.

PHENACETIN for therapeutic use (excluding when present as an excipient).

PHENAGLYCODOL.

PHENAZONE except when included in Schedule 2 or 5.

PHENAZOPYRIDINE.

PHENELZINE.

PHENETICILLIN.

PHENFORMIN.

PHENGLUTARIMIDE.

PHENINDIONE.

PHENIRAMINE except when included in Schedule 2 or 3.

PHENISATIN.

PHENOBARBITONE.

PHENOL in preparations for injection.

PHENOLPHTHALEIN for human therapeutic use.

PHENOXYBENZAMINE.

PHENOXYMETHYLPENICILLIN.

PHENSUXIMIDE.

# PHENTERMINE.

PHENTHIMENTONIUM.

PHENTOLAMINE.

PHENYLBUTAZONE.

PHENYLEPHRINE:

(a) in preparations for injection; or

(b) in preparations for human ophthalmic use containing 5 per cent or more
of phenylephrine.

PHENYLPROPANOLAMINE.

PHENYLTOLOXAMINE.

PHENYTOIN.

PHOLCODINE:

(a) in divided preparations containing 100 mg or less of pholcodine per dosage unit; or

(b) in undivided preparations containing 2.5 per cent or less of pholcodine,

PHOSPHODIESTERASE TYPE 5 INHIBITORS except:

(b) when present as an unmodified, naturally occurring substance.

PHTHALYLSULFATHIAZOLE.

PHYSOSTIGMINE.

PICROTOXIN.

PILOCARPINE except in preparations containing 0.025 per cent or less of pilocarpine.

PIMECROLIMUS.

PIMOBENDAN.

PIMOZIDE.

PINACIDIL.

PINDOLOL.

PIOGLITAZONE.

PIPECURONIUM.

PIPEMIDIC ACID.

PIPENZOLATE.

PIPER METHYSTICUM (kava) in preparations for human use except when included on the Australian Register of Therapeutic Goods in preparations:

(a) for oral use when present in tablet, capsule or teabag form that is labelled with a recommended maximum daily dose of 250 mg or less of kavalactones and:

(i) the tablet or capsule form contains 125 mg or less of kavalactones per tablet or capsule; or

(ii) the amount of dried whole or peeled rhizome in the teabag does not exceed 3 g;

and, where containing more than 25 mg of kavalactones per dose, compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in topical preparations for use on the rectum, vagina or throat containing dried whole or peeled rhizome or containing aqueous dispersions or aqueous extracts of whole or peeled rhizome; or

(c) in dermal preparations.

PIPERACILLIN.

PIPERIDINE.

PIPERIDOLATE.

PIPOBROMAN.

PIPOTHIAZINE.

PIPRADROL.

PIRACETAM.

PIRBUTEROL.

PIRENOXINE (catalin).

PIRENZEPINE.

PIRETANIDE.

PIROXICAM except in preparations for dermal use.

PIRPROFEN.

PITUITARY HORMONES except when separately specified in these Schedules.

PIVAMPICILLIN.

PIZOTIFEN.

PLICAMYCIN.

PLERIXAFOR.

PNEUMOCOCCAL VACCINE.

PODOPHYLLOTOXIN for human use:

PODOPHYLLUM EMODI (podophyllin) for human use:

PODOPHYLLUM PELTATUM (podophyllin) for human use:

POLIDEXIDE.

POLIOMYELITIS VACCINE.

POLYACRYLAMIDE in preparations for injection or implantation:

POLYESTRADIOL.

POLYLACTIC ACID in preparations for injection or implantation:

POLYMYXIN.

POLYSULFATED GLYCOSAMINOGLYCANS in preparations for injection, except when separately specified in these Schedules.

POLYTHIAZIDE.

PORACTANT.

POSACONAZOLE.

POTASSIUM BROMIDE for therapeutic use.

POTASSIUM CHLORIDE in oral preparations for human therapeutic use except:

(a) when containing less than 550 mg of potassium chloride per dosage unit;

(b) in preparations for oral rehydration therapy;

(c) in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures; or

(d) in preparations for enteral feeding.

POTASSIUM PERCHLORATE for therapeutic use.

PRACTOLOL.

PRALIDOXIME.

PRAMIPEXOLE.

PRAMOCAINE.

PRAMPINE.

# PRASTERONE (dehydroepiandrosterone, dehydroisoandrosterone).

PRASUGREL.

PRAVASTATIN.

PRAZEPAM.

PRAZIQUANTEL for human therapeutic use.

PRAZOSIN.

PREDNISOLONE.

PREDNISONE.

PREGABALIN.

PREGNENOLONE.

PRENALTEROL.

PRENYLAMINE.

PRILOCAINE except when included in Schedule 2.

PRIMAQUINE.

PRIMIDONE.

PROBENECID.

PROBUCOL.

PROCAINAMIDE.

PROCAINE.

PROCAINE PENICILLIN.

PROCARBAZINE.

PROCHLORPERAZINE except when included in Schedule 3.

PROCYCLIDINE except when included in Schedule 2.

PROGESTERONE except when included in Schedule 5.

PROGESTOGENS except when separately specified in these Schedules.

PROGLUMIDE.

PROGUANIL.

PROLINTANE.

PROMAZINE.

PROMETHAZINE except when included in Schedule 2 or 3.

PROMOXOLANE.

PROPAFENONE.

PROPAMIDINE for therapeutic use except when included in Schedule 2.

PROPANIDID.

PROPANTHELINE.

PROPENTOFYLLINE.

# PROPETANDROL.

PROPIONIBACTERIUM ACNES for therapeutic use.

PROPOFOL.

PROPRANOLOL.

PROPYLHEXEDRINE.

PROPYLTHIOURACIL.

PROPYPHENAZONE.

PROQUAZONE.

PROSCILLARIDIN.

PROSTAGLANDINS except when separately specified in this Schedule.

PROSTIANOL.

PROTAMINE.

PROTHIONAMIDE.

PROTHIPENDYL.

PROTIRELIN.

PROTOVERATRINES.

PROTRIPTYLINE.

PROXYMETACAINE.

PSEUDOEPHEDRINE except when included in Schedule 3.

PYRAZINAMIDE.

PYRIDINOLCARBAMATE.

PYRIDOSTIGMINE.

PYRIDOXINE, PYRIDOXAL OR PYRIDOXAMINE for human therapeutic use except:

(a) in oral preparations containing 200 mg or less but more than 50 mg of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

(b) in oral preparations containing 50 mg or less of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose.

PYRIMETHAMINE.

PYROVALERONE.

PYRVINIUM.

QUAZEPAM.

QUETIAPINE.

QUINAGOLIDE.

QUINAPRIL.

# QUINBOLONE.

QUINETHAZONE.

QUINIDINE.

QUININE for human therapeutic use except when the maximum recommended daily dose is 50 mg or less of quinine.

QUINISOCAINE (dimethisoquin).

QUINUPRISTIN.

RABEPRAZOLE except when included in Schedule 3.

RABIES VACCINE.

RACTOPAMINE except when included in Schedule 5.

RALOXIFENE.

RALTEGRAVIR.

RALTITREXED.

RAMIPRIL.

RANIBIZUMAB.

RANITIDINE except:

(b) in divided preparations for oral use containing 150mg or less of ranitidine per dosage unit when supplied in the manufacturer’s original pack containing not more than 14 dosage units.

RAPACURONIUM.

RASAGILINE.

RASBURICASE.

RAUWOLFIA SERPENTINA.

RAUWOLFIA VOMITORIA.

RAZOXANE.

REBOXETINE.

RED YEAST RICE for human therapeutic use.

REMOXIPRIDE.

REPAGLINIDE.

RESERPINE.

RETEPLASE.

RIBAVIRIN.

RIFABUTIN.

RIFAMPICIN.

RIFAMYCIN.

RIFAPENTINE.

RILPIVIRINE.

RILUZOLE.

RIMEXOLONE.

RIMITEROL.

RIMONABANT.

RISEDRONIC ACID.

RISPERIDONE.

RITODRINE.

RITONAVIR.

RITUXIMAB.

RIVAROXABAN.

RIVASTIGMINE.

RIZATRIPTAN.

ROBENACOXIB.

ROCURONIUM.

ROFECOXIB.

ROFLUMILAST.

ROLITETRACYCLINE.

ROMIFIDINE.

ROMIPLOSTIM.

RONIDAZOLE.

ROPINIROLE.

ROPIVACAINE.

ROSIGLITAZONE.

ROSOXACIN.

ROSUVASTATIN.

ROTIGOTINE.

# ROXIBOLONE.

ROXITHROMYCIN.

RUBELLA VACCINE.

RUBOXISTAURIN.

RUPATADINE.

SALBUTAMOL except when included in Schedule 3.

SALCATONIN.

SALICYLAMIDE when combined with aspirin, caffeine or paracetamol or any derivative of these substances.

SALINOMYCIN except:

(b) in animal feeds containing 60 mg/kg or less of antibiotic substances.

SALMETEROL.

SAPROPTERIN.

SAQUINAVIR.

SAXAGLIPTIN.

SCHOENOCAULON OFFICINALE (sabadilla) except in preparations containing 10 mg/kg or 10 mg/L or less of total alkaloids of Schoenocaulon officinale.

SCOPOLIA CARNIOLICA for therapeutic use.

SELEGILINE.

SELENIUM:

(a) for human oral use with a recommended daily dose of more than 300 micrograms; or

(b) for the treatment of animals except:

(i) when included in Schedule 6 or 7;

(ii) in solid, slow release bolus preparations each weighing 100 g or more and containing 300 mg or less of selenium per dosage unit;

(iii) in other divided preparations containing 30 micrograms or less of selenium per dosage unit;

(iv) as elemental selenium, in pellets containing 100 g/kg or less of selenium; or

(v) in feeds containing 1 g/tonne or less of selenium.

SERMORELIN.

SERTINDOLE.

SERTRALINE.

SEVELAMER.

SEVOFLURANE.

SEX HORMONES and all substances having sex hormonal activity except when separately specified in these Schedules.

SIBUTRAMINE.

# SILANDRONE.

SILDENAFIL.

SILICONES for intra-ocular use.

SILVER SULFADIAZINE.

SIMVASTATIN.

SIROLIMUS.

SISOMICIN (sisomycin).

SITAGLIPTIN.

# SITAXENTAN.

SODIUM BROMIDE for therapeutic use.

SODIUM CELLULOSE PHOSPHATE for human internal use.

SODIUM CROMOGLYCATE except when included in Schedule 2.

SODIUM MORRHUATE in preparations for injection.

SODIUM NITROPRUSSIDE for human therapeutic use.

SODIUM PHOSPHATE in preparations for oral laxative use.

SODIUM POLYSTYRENE SULPHONATE for human therapeutic use.

SODIUM SALICYLATE in preparations for injection for the treatment of animals.

SODIUM TETRADECYLSULFATE in preparations for injection.

SOLASODINE.

SOLIFENACIN.

SOMATOSTATIN.

SOMATOTROPIN EQUINE.

# SOMATROPIN (human growth hormone).

SONTOQUINE.

SORAFENIB.

SOTALOL.

SPARFLOXACIN.

SPARTEINE.

SPECTINOMYCIN.

SPIRAMYCIN.

SPIRAPRIL.

SPIRONOLACTONE.

# STANOLONE.

# STANOZOLOL.

STAVUDINE.

# STENBOLONE.

STEROID HORMONES except when separately specified in these Schedules.

STILBOESTROL (diethylstilboestrol).

STREPTODORNASE.

STREPTOKINASE.

STREPTOMYCIN.

STRONTIUM RANELATE.

STROPHANTHINS.

STROPHANTHUS spp.

STRYCHNINE in preparations containing 1.5 per cent or less of strychnine for the treatment of animals.

STRYCHNOS spp. except in preparations containing 1 mg or less per litre or per kilogram of strychnine.

STYRAMATE.

SUCCIMER.

SUGAMMADEX.

SULBACTAM.

SULCONAZOLE except when included in Schedule 2.

SULFACETAMIDE except when included in Schedule 3 or 5.

SULFADIAZINE except when included in Schedule 5.

SULFADIMETHOXINE.

SULFADIMIDINE except when included in Schedule 5.

SULFADOXINE.

SULFAFURAZOLE.

SULFAGUANIDINE.

SULFAMERAZINE except when included in Schedule 5.

SULFAMETHIZOLE.

SULFAMETHOXAZOLE.

SULFAMETHOXYDIAZINE.

SULFAMETHOXYPYRIDAZINE.

SULFAMETROLE.

SULFAMONOMETHOXINE.

SULFAMOXOLE.

SULFAPHENAZOLE.

SULFAPYRIDINE.

SULFAQUINOXALINE.

SULFASALAZINE.

SULFATHIAZOLE except when included in Schedule 5.

SULFATROXAZOLE.

SULFINPYRAZONE.

SULFOMYXIN.

SULFONAMIDES except:

(b) when included in Schedule 3, 5 or 6; or

(c) when packed and labelled solely for use as a herbicide.

SULFONMETHANE (sulfonal) and alkyl sulfonals.

SULINDAC.

SULTAMICILLIN.

SULTHIAME.

SUMATRIPTAN.

SUNITINIB.

SUPROFEN.

SUTILAINS.

SUXAMETHONIUM.

SUXETHONIUM.

TACRINE.

TACROLIMUS.

TADALAFIL.

TAFLUPROST.

TAMOXIFEN.

TAMSULOSIN.

TANACETUM VULGARE except in preparations containing 0.8 per cent or less of oil of tansy.

TASONERMIN.

TAZAROTENE.

TAZOBACTAM.

T-CELL RECEPTOR ANTIBODY.

TEGAFUR.

TEGASEROD.

TELITHROMYCIN.

TEICOPLANIN.

TELBIVUDINE.

TELMISARTAN.

TEMAZEPAM.

TEMOZOLOMIDE.

TEMSIROLIMUS.

TENECTEPLASE.

TENIPOSIDE.

TENOFOVIR.

TENOXICAM.

TEPOXALIN.

TERAZOSIN.

TERBINAFINE except:

TERBUTALINE except when included in Schedule 3.

TERFENADINE.

# TERIPARATIDE.

TERLIPRESSIN.

TERODILINE.

TEROPTERIN.

# TESTOLACTONE.

# TESTOSTERONE except when included in Schedule 6.

TETANUS ANTITOXIN except when used for short-term protection or treatment of tetanus in animals.

TETANUS TOXOID for human use.

TETRABENAZINE.

TETRACOSACTRIN.

TETRACYCLINE except when included in Schedule 5.

TETRAETHYLAMMONIUM.

TETROXOPRIM.

# THALIDOMIDE.

THENYLDIAMINE.

THEOPHYLLINE except when included in Schedule 3.

THEVETIA PERUVIANA.

THEVETIN.

THIACETARSAMIDE in preparations for the prevention or treatment of heartworm in dogs.

THIAMBUTOSINE.

THIAZOSULFONE.

THIETHYLPERAZINE.

THIOACETAZONE.

THIOCARLIDE.

THIOGUANINE.

# THIOMESTERONE (tiomesterone).

THIOPENTONE.

THIOPROPAZATE.

THIOPROPERAZINE.

THIORIDAZINE.

THIOSTREPTON.

THIOTEPA.

THIOTHIXENE.

THIOURACIL.

THIOUREA for therapeutic use except in preparations containing 0.1 per cent or less of thiourea.

THYMOXAMINE (includes thymoxamine hydrochloride).

THYROID except when separately specified in this Schedule.

THYROTROPHIN.

THYROXINE (includes thyroxine sodium).

TIAGABINE.

TIAMULIN.

TIAPROFENIC ACID.

TIARAMIDE.

TIBOLONE.

TICARCILLIN.

TICLOPIDINE.

TIEMONIUM.

TIENILIC ACID.

TIGECYCLINE.

TIGLOIDINE.

TILETAMINE.

TILMICOSIN.

TILUDRONIC ACID (includes disodium tiludronate).

TIMOLOL.

TINIDAZOLE.

TINZAPARIN (includes tinzaparin sodium).

TIOCONAZOLE except:

TIOTROPIUM.

TIPEPIDINE.

TIPRANAVIR.

TIRILAZAD.

TIROFIBAN.

TOBRAMYCIN.

TOCAINIDE.

TOCILIZUMAB.

TOLAZAMIDE.

TOLAZOLINE.

TOLBUTAMIDE.

TOLCAPONE.

TOLFENAMIC ACID.

TOLMETIN.

TOLONIUM.

TOLPROPAMINE.

TOLRESTAT.

TOLTERODINE.

TOLVAPTAN.

TOPIRAMATE.

TOPOTECAN.

TORASEMIDE.

TOREMIFENE.

TOXOIDS for human parenteral use except when separately specified in these Schedules.

TRAMADOL.

TRANDOLAPRIL.

TRANEXAMIC ACID.

TRANYLCYPROMINE.

TRASTUZUMAB.

TRAVOPROST.

TRAZODONE.

# TRENBOLONE (trienbolone, trienolone) except when included in Schedule 5.

TREOSULPHAN.

TREPROSTINIL.

# TRESTOLONE.

TRETAMINE.

# TRETINOIN.

TRIACETYLOLEANDOMYCIN.

TRIAMCINOLONE except when included in Schedule 2 or 3.

TRIAMTERENE.

TRIAZIQUONE.

TRIAZOLAM.

TRICHLORMETHIAZIDE.

TRICHLOROACETIC ACID for human dermal use except when in preparations containing 12.5 per cent or less of trichloroacetic acid for the treatment of warts other than anogenital warts.

TRICHLOROETHYLENE for therapeutic use.

TRICLOFOS.

TRICYCLAMOL.

TRIDIHEXETHYL.

TRIFLUOPERAZINE.

TRIFLUPERIDOL.

TRIFLUPROMAZINE.

TRILOSTANE.

TRIMEPRAZINE except when included in Schedule 2 or 3.

TRIMETAPHAN.

TRIMETHOPRIM.

TRIMIPRAMINE.

TRIMUSTINE.

TRINITROPHENOL (excluding its derivatives) in preparations for human therapeutic use.

TRIOXYSALEN.

TRIPELENNAMINE.

TRIPLE ANTIGEN VACCINE.

TRIPROLIDINE except when included in Schedule 2 or 3.

TRIPTORELIN.

TROGLITAZONE.

TROMETAMOL in preparations for injection except in preparations containing 3 per cent or less of trometamol.

TROPICAMIDE.

TROPISETRON.

TROVAFLOXACIN.

TROXIDONE.

TRYPTOPHAN for human therapeutic use except in preparations labelled with a recommended daily dose of 100 mg or less of tryptophan.

TUBERCULIN.

TUBOCURARINE.

TULATHROMYCIN.

TULOBUTEROL.

TYLOSIN except:

(b) in animal feeds containing 50 mg/kg or less of antibiotic substances:

(i) for growth promotion;

(ii) for the prevention of liver abscesses in cattle; or

(iii) for the prevention of ileitis in pigs; or

(c) in milk replacers for calves, or starter rations for pigs, containing 100 mg/kg or less of antibiotic substances.

TYPHOID VACCINE.

UNOPROSTONE.

URACIL.

URAPIDIL.

URETHANE (excluding its derivatives) for therapeutic use.

# UROFOLLITROPIN.

UROKINASE.

URSODEOXYCHOLIC ACID.

USTEKINUMAB.

VACCINES for human therapeutic use except when separately specified in this Schedule.

VACCINES, veterinary live virus except:

(a) poultry vaccines;

(b) pigeon pox vaccine; or

(c) scabby mouth vaccine.

VACCINIA VIRUS VACCINE.

VALACICLOVIR.

VALDECOXIB.

VALGANCICLOVIR.

VALNOCTAMIDE.

VALPROIC ACID.

VALSARTAN.

VANCOMYCIN.

VARDENAFIL.

VARENICLINE.

VARICELLA VACCINE.

VASOPRESSIN.

VECURONIUM.

VEDAPROFEN.

VENLAFAXINE.

VERAPAMIL.

VERATRUM spp. except when separately specified in this Schedule.

VERTEPORFIN.

VIDARABINE.

VIGABATRIN.

VILDAGLIPTIN.

VILOXAZINE.

VINBLASTINE.

VINCAMINE.

VINCRISTINE.

VINDESINE.

VINFLUNINE.

VINORELBINE.

VINYL ETHER for therapeutic use.

VIRGINIAMYCIN except when included in Schedule 5.

VISNADINE.

VITAMIN A for human therapeutic or cosmetic use except:

(a) in preparations for topical use containing 1 per cent or less of Vitamin A;

(b) in preparations for internal use containing 3000 micrograms retinol equivalents or less of Vitamin A per daily dose; or

(c) in preparations for parenteral nutrition replacement.

VITAMIN D for human internal therapeutic use except in preparations containing 25 micrograms or less of Vitamin D per recommended daily dose.

VORICONAZOLE.

VORINOSTAT.

WARFARIN for therapeutic use.

XAMOTEROL.

XANTHINOL NICOTINATE.

XIMELAGATRAN.

XIPAMIDE.

XYLAZINE.

YOHIMBINE.

ZAFIRLUKAST.

ZALCITABINE.

ZALEPLON.

ZANAMIVIR.

ZERANOL except when included in Schedule 6.

ZIDOVUDINE.

ZILPATEROL.

ZIMELDINE.

ZINC COMPOUNDS for human internal use except:

(a) in preparations with a recommended daily dose of 25 mg or less of zinc; or

(b) in preparations with a recommended daily dose of more than 25 mg but not more than 50 mg of zinc when compliant with the requirements of the Required Advisory Statements for Medicine Labels.

ZIPRASIDONE.

ZOLAZEPAM.

ZOLEDRONIC ACID.

ZOLMITRIPTAN.

ZOLPIDEM.

ZONISAMIDE.

ZOPICLONE.

ZOXAZOLAMINE.

ZUCLOPENTHIXOL.

SCHEDULE 5

ABAMECTIN in preparations, for internal use for the treatment of animals,

containing 1 per cent or less of abamectin.

ABSCISIC ACID.

ACETIC ACID (excluding its salts and derivatives) in preparations containing more than 30 per cent of acetic acid (CH3COOH) except:

(a) when included in Schedule 2 or 6; or

ACETONE except in preparations containing 25 per cent or less of designated solvents.

ACRIFLAVINE in preparations for veterinary use containing 2.5 per cent or less of acriflavine.

AKLOMIDE.

ALBENDAZOLE for the treatment of animals, in preparations containing 12.5 per cent or less of albendazole except in intraruminal implants each containing 3.85 g or less of albendazole.

† ALKALINE SALTS, being the carbonate, silicate or phosphate salts of sodium or potassium alone or in any combination:

(a) in solid orthodontic device cleaning preparations, the pH of which as an “in-use” aqueous solution is more than 11.5;

(b) in solid automatic dishwashing preparations, the pH of which in a 500 g/L aqueous solution or mixture is more than 11.5 but less than or equal to 12.5;

(c) in other solid preparations, the pH of which in a 10 g/L aqueous solution is more than 11.5; or

(d) in liquid or semi-solid preparations the pH of which is more than 11.5, unless:

(i) in food additive preparations for domestic use; or

(ii) in automatic dish washing preparations for domestic use with a pH of more than 12.5,

except when separately specified in these Schedules.

ALKOXYLATED FATTY ALKYLAMINE POLYMER in preparations containing 50 per cent or less of alkoxylated fatty alkylamine polymer except in preparations containing 20 per cent or less of alkoxylated fatty alkylamine polymer.

ALLETHRIN in preparations containing 10 per cent or less of allethrin except:

(a) in insecticidal mats; or

(b) in other preparations containing 1 per cent or less of allethrin.

ALLOXYDIM.

ALPHA-CYPERMETHRIN:

(a) in aqueous preparations containing 3 per cent or less of alpha-cypermethrin; or

(b) in other preparations containing 1.5 per cent or less of alpha-cypermethrin.

AMETRYN.

AMINACRINE in preparations for veterinary use containing 2.5 per cent or less of aminacrine.

AMINES for use as curing agents for epoxy resins except when separately specified in these Schedules.

AMITROLE.

AMMONIA (excluding its salts and derivatives other than ammonium hydroxide) in preparations containing 5 per cent or less of ammonia except:

(a) in preparations for human internal therapeutic use;

(b) in preparations for inhalation when absorbed in an inert solid material; or

(c) in preparations containing 0.5 per cent or less of free ammonia.

AMMONIUM THIOCYANATE except in preparations containing 10 per cent or less of ammonium thiocyanate.

ANHYDRIDES, ORGANIC ACID, for use as curing agents for epoxy resins except when separately specified in these Schedules.

ANISE OIL except:

(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert, and labelled with the warning:

(c) in preparations containing 50 per cent or less of anise oil.

ASPIRIN for the treatment of animals, in divided preparations when packed in blister or strip packaging or in a container with a child-resistant closure.

ATRAZINE.

† AZADIRACHTA INDICA EXTRACTS (neem extracts), extracted from neem seed kernels using water, methanol or ethanol, in preparations containing 5 per cent or less of total limonoids, for agricultural use.

AZOXYSTROBIN.

BACILLUS THURINGIENSIS delta endotoxin encapsulated in killed Pseudomonas fluorescens.

BARIUM SILICOFLUORIDE when coated on paper in an amount not exceeding 8 mg of barium silicofluoride per sq. cm.

BASIL OIL except:

(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

(c) in preparations containing 5 per cent or less of methyl chavicol.

BEAUVERIA BASSIANA in preparations containing 1 x 108 Colony Forming Units (CFU)/mL or less of Beauveria bassiana.

BENALAXYL.

BENDIOCARB in preparations containing 2 per cent or less of bendiocarb.

BENTAZONE.

BENZALKONIUM CHLORIDE in preparations containing 10 per cent or less of benzalkonium chloride except in preparations containing 5 per cent or less of benzalkonium chloride.

BENZOFENAP.

BENZOYL PEROXIDE except:

(b) in preparations containing 5 per cent or less of benzoyl peroxide.

BERGAMOT OIL except:

(c) in preparations containing 0.4 per cent or less of bergamot oil;

(e) in medicines for human therapeutic use when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

BETACYFLUTHRIN:

(a) in aqueous preparations containing 2.5 per cent or less of betacyfluthrin; or

(b) in solid preparations containing 8 per cent or less of betacyfluthrin in a plastic matrix.

BIFLUORIDES (including ammonium, potassium and sodium salts) in preparations containing 0.3 per cent or less of total bifluorides.

BIOALLETHRIN in preparations containing 10 per cent or less of bioallethrin except in preparations containing 1 per cent or less of bioallethrin.

BIORESMETHRIN except in preparations containing 10 per cent or less of bioresmethrin.

BORIC ACID (excluding its salts) and BORAX except:

(b) in preparations, other than insect baits, containing 1 per cent or less of boron; or

(c) in hand cleaning preparations.

BORON TRIFLUORIDE in preparations containing 0.1 per cent or less of boron trifluoride (BF3).

BROMUCONAZOLE in preparations containing 20 per cent or less of bromuconazole.

BUPROFEZIN except in preparations containing 40 per cent or less of buprofezin.

BUTHIDAZOLE.

BUTOXYCARBOXIM in solid preparations containing 10 per cent or less of butoxycarboxim.

BUTRALIN.

BUTROXYDIM.

CAMPHOR as a natural component in essential oils containing 10 per cent or less of camphor except:

(a) in medicines for human therapeutic use, in essential oils when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations other than medicines for human therapeutic use, in essential oils when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warnings:

(c) in rosemary oil, sage oil (Spanish), or lavandin oils; or

(d) in preparations containing 2.5 per cent or less of camphor.

CARBAMIDE PEROXIDE in preparations containing 18 per cent or less of carbamide peroxide except in preparations containing 9 per cent or less of carbamide peroxide.

CARBARYL:

(a) in preparations containing 10 per cent or less of carbaryl except when included in Schedule 4; or

(b) when impregnated into plastic resin material containing 20 per cent or less of carbaryl.

CASSIA OIL except:

(a) in food additives;

(b) in preparations for dermal use as a rubefacient containing 5 per cent or less of cassia oil; or

(c) in other preparations containing 2 per cent or less of cassia oil.

CHLORFENAC.

CHLORFENSON.

CHLORHEXIDINE in preparations containing 3 per cent or less of chlorhexidine except:

(a) in preparations containing 1 per cent or less of chlorhexidine; or

(b) when in solid preparations.

CHLORINATING COMPOUNDS containing 20 per cent or less of available chlorine, except:

(b) sodium hypochlorite preparations with a pH of less than 11.5;

(c) liquid preparations containing not less than 2 per cent but not more than 4 per cent of available chlorine when labelled with the statements:

WARNING – Ensure adequate ventilation when using. Vapour may be harmful. May give off dangerous gas if mixed with other products;

(d) liquid preparations containing less than 2 per cent of available chlorine; or

(e) other preparations containing 4 per cent or less of available chlorine.

CHLORNIDINE.

CHLOROCRESOL except in preparations containing 3 per cent or less of chlorocresol.

CHLORPROPHAM.

CHLORPYRIFOS:

(a) in aqueous preparations containing 20 per cent or less of microencapsulated chlorpyrifos;

(b) in controlled release granular preparations containing 10 per cent or less of chlorpyrifos; or

(c) in other preparations containing 5 per cent or less of chlorpyrifos,

except in prepared potting or soil mixes containing 100 g or less of chlorpyrifos per cubic metre.

CHLORSULFURON.

CHLORTETRACYCLINE in preparations:

(b) containing 40 per cent or less of chlortetracycline, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

CHLORTHAL-DIMETHYL.

CINMETHYLIN.

CINNAMON BARK OIL except:

(a) in food additives; or

(b) in preparations containing 2 per cent or less of cinnamon bark oil.

CLETHODIM.

CLIMBAZOLE in preparations containing 40 per cent or less of climbazole except in preparations containing 2 per cent or less of climbazole.

CLOFENTEZINE.

CLOPYRALID.

CLOQUINTOCET-MEXYL.

CLORSULON.

CLOTHIANIDIN in preparations containing 20 per cent or less of clothianidin.

CLOVE OIL for topical use in the mouth in a pack containing 5 mL or less of clove oil except in preparations containing 25 per cent or less of clove oil.

COPPER ACETATE in preparations containing 20 per cent or less of copper acetate except in preparations containing 5 per cent or less of copper acetate.

COPPER COMPOUNDS in animal feed additives containing 5 per cent or less of copper except in preparations containing 1 per cent or less of copper.

COPPER HYDROXIDE in preparations containing 50 per cent or less of copper hydroxide except in preparations containing 12.5 per cent or less of copper hydroxide.

COPPER OXIDES in preparations containing 25 per cent or less of copper oxides except:

(a) in preparations for internal use;

(b) in marine paints; or

(c) in other preparations containing 5 per cent or less of copper oxides.

COPPER OXYCHLORIDE in preparations containing 50 per cent or less of copper oxychloride except in preparations containing 12.5 per cent or less of copper oxychloride.

COPPER SULFATE in preparations containing 15 per cent or less of copper sulfate except:

(a) in preparations for internal use; or

(b) in other preparations containing 5 per cent or less of copper sulfate.

COUMATETRALYL in rodenticides containing 0.05 per cent or less of coumatetralyl.

4-CPA.

CYANATRYN.

CYANOACRYLATE ESTERS in contact adhesives except:

(a) when labelled with the warning:

KEEP OUT OF REACH OF CHILDREN. Avoid contact with skin and eyes and avoid breathing vapour. Bonds on contact. Should fingers stick together apply a solvent such as acetone to contact areas then wash off with water. Do not use solvents near eyes or open wounds. In case of eye contact immediately flush with water; or

(b) when packed in sealed measure packs each containing 0.5 g or less of cyanoacrylate esters:

(i) labelled with the approved name or trade name of the poison, the quantity and the warning:

Can cause eye injury. Instantly bonds skin; and

(ii) enclosed in a primary pack labelled with the warning:

KEEP OUT OF REACH OF CHILDREN. Avoid contact with skin and eyes and avoid breathing vapour. Bonds on contact. Should fingers stick together apply a solvent such as acetone to contact areas then wash off with water. Do not use solvents near eyes or open wounds. In case of eye contact immediately flush with water.

CYANURIC ACID (excluding its salts and derivatives).

CYCLOHEXANONE PEROXIDE.

CYCLOPROTHRIN except in preparations containing 10 per cent or less of cycloprothrin.

CYCLOXYDIM.

CYFLUTHRIN:

(a) in wettable powders containing 10 per cent or less of cyfluthrin;

(b) in emulsifiable concentrates containing 2 per cent or less of cyfluthrin; or

(c) in emulsions containing 5 per cent or less of cyfluthrin.

cyhalofop-butyl.

CYMIAZOLE.

CYPERMETHRIN in preparations containing 10 per cent or less of cypermethrin.

CYPHENOTHRIN in preparations containing 10 per cent or less of cyphenothrin.

CYPROCONAZOLE except in preparations containing 10 per cent or less of cyproconazole.

CYPRODINIL.

CYSTEAMINE in cosmetic preparations containing 6 per cent or less of cysteamine except in preparations containing 1 per cent or less of cysteamine.

CYTHIOATE for the treatment of animals:

(a) in divided preparations containing 30 mg or less of cythioate per dosage unit when packed in blister or strip packaging or in a container with a child-resistant closure; or

(b) in undivided preparations containing 5 per cent or less of cythioate.

2,4-D in preparations containing 20 per cent or less of 2,4-D.

DAMINOZIDE.

2,4-DB.

DELTAMETHRIN:

(a) in aqueous preparations containing 5 per cent or less of deltamethrin when no organic solvent other than a glycol is present;

(b) in wettable granular preparations containing 25 per cent or less of deltamethrin when packed in child-resistant packaging each containing 3 g or less of the formulation;

(c) in water-dispersible tablets each containing 500 mg or less of deltamethrin in child-resistant packaging; or

(d) in other preparations containing 0.5 per cent or less of deltamethrin,

except in preparations containing 0.1 per cent or less of deltamethrin.

DEMBREXINE in oral preparations for the treatment of animals.

2,4-DES.

DIAFENTHIURON.

N,N-DIALLYLDICHLOROACETAMIDE except in preparations containing 10 per cent or less of N,N-diallyldichloroacetamide.

DIAZINON in dust preparations containing 2 per cent or less of diazinon.

DICAMBA (including its salts and derivatives) in preparations containing 20 per cent or less of dicamba.

DICHLONE.

para-DICHLOROBENZENE.

DICHLOROISOCYANURIC ACID containing 40 per cent or less of available chlorine, except in:

(a) liquid preparations containing not less than 2 per cent but not more than 4 per cent of available chlorine when labelled with the statements:

WARNING – Ensure adequate ventilation when using. Vapour may be harmful. May give off dangerous gas if mixed with other products;

(b) liquid preparations containing less than 2 per cent of available chlorine; or

(c) other preparations containing 4 per cent or less of available chlorine.

DICHLOROMETHANE (methylene chloride) except:

(a) in preparations in pressurised spray packs labelled as degreasers, decarbonisers or paint strippers and containing 10 per cent or less of dichloromethane;

(b) in other preparations in pressurised spray packs; or

(c) in paints and tinters containing 5 per cent or less of dichloromethane.

DICHLOROPHEN for the treatment of animals.

DICHLORVOS:

(a) when impregnated in plastic resin strip material containing 20 per cent or less of dichlorvos;

(b) in sustained release resin pellets containing 20 per cent or less of dichlorvos for the treatment of animals; or

(c) in pressurised spray packs containing 10 grams or less of dichlorvos.

DICLOBUTRAZOL.

DICLORAN.

DICOFOL.

DIETHANOLAMINE (excluding its salts and derivatives) in preparations containing 20 per cent or less of diethanolamine except in preparations containing 5 per cent or less of diethanolamine.

† DIETHYLENE GLYCOL (excluding its salts and derivatives) in preparations containing not less than 10 mg/kg of denatonium benzoate as a bittering agent except:

(a) in paints or paint tinters;

(b) in toothpastes or mouthwashes containing more than 0.25 per cent of diethylene glycol; or

(c) in other preparations containing 2.5 per cent or less of diethylene glycol.

DIETHYLENE GLYCOL MONOBUTYL ETHER except in preparations containing 10 per cent or less of diethylene glycol monobutyl ether.

DIETHYLTOLUAMIDE (DEET) except:

(a) in medicines for human therapeutic use containing 20 per cent or less of diethyltoluamide, when compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations for human use, other than medicines, containing 20 per cent or less of diethyltoluamide, when labelled with the warning statement:

WARNING: May be dangerous, particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time; or

(c) in preparations other than for human use containing 20 per cent or less of diethyltoluamide.

DIFENOCONAZOLE.

DIFLUBENZURON.

DIMETHICODIETHYLBENZALMALONATE except when included in preparations containing 10 per cent or less of dimethicodiethylbenzalmalonate.

DIMETHIRIMOL.

DIMETHOMORPH except in preparations containing 10 per cent or less of dimethomorph.

DIMETHYLACETAMIDE in preparations containing 20 per cent or less of

dimethylacetamide.

DIMETHYLFORMAMIDE in preparations containing 10 per cent or less of dimethylformamide except in silicone rubber mastic containing 2 per cent or less of dimethylformamide.

DINICONAZOLE.

DI-N-PROPYL ISOCINCHOMERONATE except in preparations containing 25 per cent or less of di-N-propyl isocinchomeronate.

DIPHENAMID.

DITHIOPYR.

N-(N-DODECYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of N-(N-dodecyl)-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-(N-dodecyl)-2-pyrrolidone, N-methyl-2-pyrrolidone or N-(N-octyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.

DORAMECTIN for internal use for the treatment of animals, in preparations containing 2 per cent or less of doramectin.

EMAMECTIN in preparations containing 2 per cent or less of emamectin.

EMODEPSIDE in preparations containing 2.5 per cent or less of emodepside for external treatment of animals.

EPOXICONAZOLE.

EPOXY RESINS, LIQUID.

EPRINOMECTIN in preparations containing 0.5 per cent or less of eprinomectin.

ESBIOTHRIN in preparations containing 10 per cent or less of esbiothrin except in pressurised spray packs containing 1 per cent or less of esbiothrin.

ESFENVALERATE in preparations containing 0.1 per cent or less of esfenvalerate.

1,2-ETHANEDIAMINE POLYMER WITH (CHLOROMETHYL)OXIRANE AND N-METHYLMETHANAMINE.

ETHANOLAMINE (excluding its salts and derivatives) in preparations containing 20 per cent or less of ethanolamine except:

(b) in preparations containing 5 per cent or less of ethanolamine.

ETHER in preparations containing more than 10 per cent of ether for use in internal combustion engines.

ETHOFUMESATE.

ETHOXYQUIN except in preparations containing 10 per cent or less of ethoxyquin.

ETHOXYSULFURON.

† ETHYLENE GLYCOL (excluding its salts and derivatives) in preparations containing not less than 10 mg/kg of denatonium benzoate as a bittering agent except:

(a) in paints or paint tinters;

(b) in toothpastes or mouthwashes containing more than 0.25 per cent of ethylene glycol; or

(c) in other preparations containing 2.5 per cent or less of ethylene glycol.

ETHYL METHACRYLATE (excluding its derivatives) for cosmetic use except in preparations containing 1 per cent or less of ethyl methacrylate as residual monomer in a polymer.

ETRIDIAZOLE.

EUGENOL for topical use in the mouth in a pack containing 5 mL or less of eugenol

except in preparations containing 25 per cent or less of eugenol.

EXTRACT OF LEMON EUCALYPTUS, being acid modified oil of lemon eucalyptus (Corymbia citriodora), except in preparations containing 40 per cent or less of extract of lemon eucalyptus.

FENARIMOL.

FENBENDAZOLE for the treatment of animals.

FENBUCONAZOLE.

FENCHLORAZOLE-ETHYL.

FENOPROP.

FENOXAPROP-ETHYL.

FENOXAPROP-P-ETHYL.

FENSON.

FENTHION:

(a) in preparations containing 25 per cent or less of fenthion when packed in single-use containers having a capacity of 2 mL or less; or

(b) in preparations containing 10 per cent or less of fenthion.

SCHEDULE 5–continued

FIPRONIL in preparations containing 10 per cent or less of fipronil except in preparations containing 0.05 per cent or less of fipronil.

FLAMPROP-METHYL.

FLAMPROP-M-METHYL.

FLORASULAM.

FLUAZURON.

FLUBENDAZOLE for the treatment of animals.

FLUBENDIAMIDE.

FLUCHLORALIN.

FLUDIOXONIL except in preparations containing 10 per cent or less of fludioxonil.

FLUMETHRIN:

(a) when impregnated in plastic resin strip material containing 3 per cent or less of flumethrin; or

(b) in oil based preparations containing 1 per cent or less of flumethrin.

flumiclorac pentyl.

FLUORIDES in preparations containing 3 per cent or less of fluoride ion except:

(a) in preparations for human use; or

FLUVALINATE in aqueous preparations containing 25 per cent or less of fluvalinate.

FORAMSULFURON.

FORMIC ACID (excluding its salts and derivatives) except in preparations containing 0.5 per cent or less of formic acid.

FOSPIRATE when impregnated in plastic resin strip material containing 20 per cent or less of fospirate.

FURALAXYL.

FURATHIOCARB in microencapsulated suspensions containing 50 per cent or less
of furathiocarb.

GAMMA-CYHALOTHRIN in aqueous preparations containing 15 per cent or less of microencapsulated gamma-cyhalothrin.

GLUFOSINATE-AMMONIUM.

GLUTARALDEHYDE in preparations containing 5 per cent or less of glutaraldehyde except:

(b) in preparations containing 0.5 per cent or less of glutaraldehyde when labelled with the statements:

GLYPHOSATE.

HALOSULFURON-METHYL.

HEXACONAZOLE except in preparations containing 5 per cent or less of hexaconazole.

HEXAZINONE in preparations containing 25 per cent or less of hexazinone.

HYDRAMETHYLNON in solid baits containing 2 per cent or less of hydramethylnon in welded plastic labyrinths.

HYDROCARBONS, LIQUID, including kerosene, diesel (distillate), mineral turpentine, white petroleum spirit, toluene, xylene and light mineral and paraffin oils (but excluding their derivatives), except:

(a) toluene and xylene when included in Schedule 6;

(b) benzene and liquid aromatic hydrocarbons when included in Schedule 7;

(c) food grade and pharmaceutical grade white mineral oils;

(d) in solid or semi-solid preparations;

(e) in preparations containing 25 per cent or less of designated solvents;

(f) in preparations packed in pressurised spray packs;

(g) in adhesives packed in containers each containing 50 grams or less of adhesive;

(h) in writing correction fluids and thinners for writing correction fluids packed in containers having a capacity of 20 mL or less; or

(i) in other preparations when packed in containers with a capacity of 2 mL or less.

HYDROCHLORIC ACID (excluding its salts and derivatives) in preparations containing
10 per cent or less of hydrochloric acid (HCl) except:

(a) in preparations containing 0.5 per cent or less of hydrochloric acid (HCl); or

HYDROFLUORIC ACID (excluding its salts and derivatives) and admixtures that generate hydrofluoric acid, in preparations containing 0.1 per cent or less of hydrogen fluoride.

HYDROGEN PEROXIDE (excluding its salts and derivatives):

(a) in hair dye preparations containing 12 per cent or less of hydrogen peroxide except in hair dyes containing 6 per cent or less of hydrogen peroxide; or

(b) in other preparations containing 6 per cent (20 volume) or less of hydrogen peroxide except in preparations containing 3 per cent (10 volume) or less of hydrogen peroxide.

HYDROSILICOFLUORIC ACID (excluding its salts and derivatives) in preparations containing 0.1 per cent or less of hydrosilicofluoric acid (H2SiF6).

IMAZALIL.

IMAZAMOX except in preparations containing 25 per cent or less of imazamox.

IMAZAPIC except in preparations containing 25 per cent or less of imazapic.

IMAZAPYR except in preparations containing 25 per cent or less of imazapyr.

IMAZETHAPYR except in preparations containing 25 per cent or less of imazethapyr.

IMIDACLOPRID in preparations containing 20 per cent or less of imidacloprid except in preparations containing 5 per cent or less of imidacloprid.

IMIPROTHRIN in preparations containing 50 per cent or less of imiprothrin except in preparations containing 10 per cent or less of imiprothrin.

INDOXACARB (includes the R and S enantiomers) in preparations containing 1 per cent or less of indoxacarb.

3-IODO-2-PROPYNYL BUTYL CARBAMATE (Iodocarb) in preparations containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate except in aqueous preparations containing 10 per cent or less of 3-iodo-2-propynyl butyl carbamate.

IODOSULFURON-METHYL-SODIUM.

IPCONAZOLE in preparations containing 2 per cent or less of ipconazole.

IRON COMPOUNDS:

(a) for the treatment of animals (excluding up to 1 per cent of iron oxides when present as an excipient):

(i) in preparations for injection containing 20 per cent or less of iron except in preparations containing 0.1 per cent or less of iron; or

(ii) in other preparations containing 4 per cent or less of iron except:

(A) in liquid or gel preparations containing 0.1 per cent or less of iron; or

(B) in animal feeds or feed premixes; or

(b) in garden preparations except in preparations containing 4 per cent or less of iron.

ISOEUGENOL in preparations containing 25 per cent or less of isoeugenol except in preparations containing 10 per cent or less of isoeugenol.

ISOPHORONE.

ISOXABEN.

ISOXAFLUTOLE.

IVERMECTIN for use in animals:

(a) in preparations for the prophylaxis of heartworm in cats and dogs;

(b) in intraruminal implants containing 160 mg or less of ivermectin;

(c) in preparations containing 3.5 per cent or less of ivermectin when packed in child-resistant packaging or in packaging approved by the relevant registration authority; or

(d) in other preparations containing 2 per cent or less of ivermectin.

KITASAMYCIN in animal feed premixes for growth promotion containing 2 per cent or less of antibiotic substances.

LAMBDA-CYHALOTHRIN:

(a) in aqueous preparations containing 1 per cent or less of lambda- cyhalothrin; or

(b) in aqueous preparations containing 2.5 per cent or less of microencapsulated lambda-cyhalothrin.

† LEAD COMPOUNDS in preparations for use as hair cosmetics.

LEMON OIL except:

(c) in preparations containing 0.05 per cent or less of lemon oil;

(e) in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

LEVAMISOLE in preparations containing 15 per cent or less of levamisole for the treatment of animals except:

(b) in preparations for the treatment of ornamental birds or ornamental fish, in packs containing 10 mg or less of levamisole.

LIME OIL except:

(c) in preparations containing 0.5 per cent or less of lime oil;

(e) in medicines for human therapeutic use, when compliant with the requirements of the Required

Advisory Statements for Medicine Labels; or

LINDANE in preparations containing 10 per cent or less of lindane except when included in Schedule 2 or 4.

LUFENURON except:

(a) in divided preparations each containing 500 mg or less of lufenuron for the treatment of animals; or

(b) in single use syringes each containing 500 mg or less of lufenuron for the treatment of animals.

MADURAMICIN in animal feed premixes containing 1 per cent or less of antibiotic substances.

MAGNESIUM CHLORATE except in preparations containing 10 per cent or less of magnesium chlorate.

MALACHITE GREEN in preparations for veterinary use containing 10 per cent or less of malachite green.

MALATHION in preparations containing 10 per cent or less of malathion except:

(a) for human therapeutic use; or

(b) in dust preparations containing 2 per cent or less of malathion.

MANCOZEB.

MANDIPROPAMID.

MARJORAM OIL except:

(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert, and labelled with the warning:

(c) in preparations containing 50 per cent or less of marjoram oil.

MCPA:

(a) in preparations containing 25 per cent or less of MCPA (acid); or

(b) in preparations containing 50 per cent or less of the salts and esters of MCPA.

MCPB.

MEBENDAZOLE for the treatment of animals:

(a) in divided preparations each containing 300 mg or less of mebendazole per dosage unit; or

(b) in undivided preparations containing 25 per cent or less of mebendazole.

MECLOFENAMIC ACID for the treatment of animals.

MECOPROP in preparations containing 2 per cent or less of mecoprop.

MEFENPYR-DIETHYL.

MEPIQUAT.

METAFLUMIZONE.

METALAXYL in preparations containing 35 per cent or less of metalaxyl.

METALDEHYDE in preparations containing 2 per cent or less of metaldehyde.

METHABENZTHIAZURON.

METHANOL (excluding its derivatives) in preparations containing 10 per cent or less of methanol except in preparations containing 2 per cent or less of methanol.

METHIOCARB in pelleted preparations containing 2 per cent or less of methiocarb.

METHOXYCHLOR.

METHYLATED SPIRIT(S) (being ethanol denatured with denatonium benzoate, methyl isobutyl ketone and fluorescein) except:

(a) when included in preparations or admixtures; or

(b) when packed in containers having a capacity of more than 5 litres.

METHYLENE BLUE in preparations for veterinary use containing 50 per cent or less of methylene blue.

METHYL ETHYL KETONE except in preparations containing 25 per cent or less of designated solvents.

METHYL ETHYL KETONE PEROXIDE.

METHYL ISOAMYL KETONE except in preparations containing 25 per cent or less of designated solvents.

METHYL ISOBUTYL KETONE except in preparations containing 25 per cent or less of designated solvents.

N-METHYL-2-PYRROLIDONE:

(a) when packed in single use containers having a capacity of 2 mL or less; or

(b) in preparations containing 50 per cent or less of N-methyl-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-methyl-2-pyrrolidone, N-(N-octyl)-2-pyrrolidone or N-(N-dodecyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.

METHYL SALICYLATE in preparations containing 25 per cent or less of methyl salicylate except:

(a) in preparations for therapeutic use; or

(b) in preparations containing 5 per cent or less of methyl salicylate.

2-METHYLTHIO-4-(2-METHYLPROP-2-YL) AMINO-6-CYCLOPROPYLAMINO-5- TRIAZINE.

METIRAM.

METOLACHLOR.

METRAFENONE in preparations containing 50 per cent or less of metrafenone.

MILBEMECTIN in preparations containing 1 per cent or less of milbemectin.

MILBEMYCIN OXIME for the prophylaxis of heartworm in dogs and cats.

MONENSIN in intraruminal implants for cattle, each containing 35 g or less of monensin.

MONEPANTEL.

MORANTEL in preparations containing 25 per cent or less of morantel except in preparations containing 10 per cent or less of morantel.

MOXIDECTIN:

(a) in preparations for external use for the treatment of animals other than cats and dogs, containing 0.5 per cent or less of moxidectin;

(b) in preparations for external use for the treatment of cats and dogs, containing 2.5 per cent or less of moxidectin packed in single dose tubes with a volume of 1 mL or less; or

(c) for internal use for the treatment of animals:

(i) in divided preparations for dogs, containing 250 micrograms or less of moxidectin per dosage unit in a pack containing six or less dosage units; or

(ii) in other preparations containing 2 per cent or less of moxidectin.

MYCLOBUTANIL.

NAA except in preparations containing 25 per cent or less of NAA.

NALED when impregnated in plastic resin strip material containing 20 per cent or less of naled.

NAPTALAM.

NETOBIMIN for the treatment of animals, in preparations containing 12.5 per cent or less of netobimin.

NITRIC ACID (excluding its salts and derivatives) in preparations containing 10 per cent or less of nitric acid (HNO3) except in preparations containing 0.5 per cent or less of nitric acid.

NITROSCANATE for the treatment of animals.

NONOXINOL 9 in preparations containing 25 per cent or less of nonoxinol 9 except:

(a) when labelled with the statements:

(b) in preparations containing 12.5 per cent or less of nonoxinol 9; or

(c) in preparations for human use.

NORBORMIDE.

NUTMEG OIL except:

(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

(c) in preparations containing 50 per cent or less of nutmeg oil.

N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE except in preparations containing 10 per cent or less of N-octyl bicycloheptene dicarboximide.

N-(N-OCTYL)-2-PYRROLIDONE in preparations containing 50 per cent or less of N-(N-octyl)-2-pyrrolidone or preparations containing 50 per cent or less of a mixture of any two or more of N-(N-octyl)-2-pyrrolidone, N-methyl-2-pyrrolidone or N-(N-dodecyl)-2-pyrrolidone except in preparations containing 25 per cent or less of designated solvents.

OESTRADIOL in implant preparations for growth promotion in animals.

OLEANDOMYCIN in animal feed premixes for growth promotion.

OMETHOATE in pressurised spray packs containing 0.2 per cent or less of omethoate.

ORANGE OIL (BITTER) except:

(c) in preparations containing 1.4 per cent or less of orange oil (bitter);

(e) in medicines for human therapeutic use, when compliant with the requirements of the Required Advisory Statements for Medicine Labels; or

OXADIARGYL.

OXADIXYL.

OXANTEL EMBONATE for the treatment of animals.

OXFENDAZOLE for the treatment of animals.

OXIBENDAZOLE for the treatment of animals.

OXYCARBOXIN.

OXYTETRACYCLINE in preparations:

(b) containing 40 per cent or less of oxytetracycline per dose, when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

OXYTHIOQUINOX.

PACLOBUTRAZOL.

PENCONAZOLE.

PENDIMETHALIN.

PERACETIC ACID in concentrations of 10 per cent or less of peracetic acid.

PERMETHRIN (excluding preparations for human therapeutic use):

(a) in preparations containing 25 per cent or less of permethrin; or

(b) in preparations for external use, for the treatment of dogs, containing 50 per cent or less of permethrin when packed in single use containers having a capacity of 4 mL or less,

except in preparations containing 2 per cent or less of permethrin.

PETROL except preparations containing 25 per cent or less of petrol.

PHENAZONE for the external treatment of animals.

PHENISOPHAM.

PHENOL, including cresols and xylenols and any other homologue of phenol boiling below 220°C, when in animal feed additives containing 15 per cent or less of such substances, except in preparations containing 3 per cent or less of such substances.

PHENYL METHYL KETONE except in preparations containing 25 per cent or less of designated solvents.

ortho-PHENYLPHENOL except in preparations containing 5 per cent or less of o-phenylphenol.

PHOSPHONIC ACID (excluding its salts and derivatives) except in preparations containing 10 per cent or less of phosphonic acid (H3PO3).

PHOSPHORIC ACID (excluding its salts and derivatives) in preparations containing 35 per cent or less of phosphoric acid (H3PO4) except:

(a) in preparations containing 15 per cent or less of phosphoric acid (H3PO4);

(b) in solid or semi-solid preparations; or

(c) in professional dental kits.

ortho-PHTHALALDEHYDE in preparations containing 1 per cent or less of ortho-phthalaldehyde.

PICARIDIN except in preparations containing 20 per cent or less of picaridin.

PINE OILS in preparations containing 25 per cent or less of pine oils when packed and labelled as a herbicide.

PINOXADEN in preparations containing 10 per cent or less of pinoxaden.

PIPERAZINE for animal use.

PIRIMICARB in preparations containing 0.5 per cent or less of pirimicarb.

POLIHEXANIDE except in preparations containing 5 percent or less of polihexanide.

POLIXETONIUM SALTS in preparations containing 60 per cent or less of polixetonium salts except in preparations containing 1 per cent or less of polixetonium salts.

POLYETHANOXY (15) TALLOW AMINE.

POLY(OXY-1,2-ETHANEDIYL), -[2-[(2-HYDROXYETHYL)AMINO]-2-OXOETHYL]--HYDROXY-,MONO-C13-15-ALKYL ETHERS.

POTASSIUM CHLORATE except:

(b) in preparations containing 10 per cent or less of potassium chlorate.

† POTASSIUM HYDROXIDE (excluding its salts and derivatives) in preparations containing 5 per cent or less of potassium hydroxide being:

(a) solid preparations the pH of which in a 10 g/L aqueous solution is more than 11.5; or

(b) liquid or semi-solid preparations the pH of which is more than 11.5 except in food additive preparations for domestic use.

POTASSIUM METABISULPHITE when packed for domestic use except in preparations containing 10 per cent or less of potassium metabisulphite.

POTASSIUM NITRITE in preparations containing 1 per cent or less of potassium nitrite except:

(a) in preparations containing 0.5 per cent or less of potassium nitrite;

(b) when present as an excipient in preparations for therapeutic use; or

(c) in aerosols.

POTASSIUM PEROXOMONOSULFATE TRIPLE SALT in preparations containing 5 per cent or less of potassium peroxomonosulfate triple salt being:

(a) solid preparations the pH of which in a 10 g/L aqueous solution is less than 2.5; or

(b) liquid or semi-solid preparations the pH of which is less than 2.5.

SCHEDULE 5–continued

POTASSIUM SULFIDE in preparations for metal treatment in containers each containing 50 g or less of potassium sulfide.

PRALLETHRIN (cis:trans=20:80) in preparations containing 10 per cent or less of prallethrin except in insecticidal mats containing 1 per cent or less of prallethrin.

PROFOXYDIM except in preparations containing 20 per cent or less of profoxydim.

PROGESTERONE:

(a) in implant preparations or controlled release pessaries for synchronisation of oestrus in cattle, sheep or goats; or

(b) in implant preparations for growth promotion in cattle.

PROHEXADIONE CALCIUM.

PROMETRYN.

PROPAMOCARB.

PROPANIL.

PROPAQUIZAFOP.

PROPICONAZOLE in preparations containing 20 per cent or less of propiconazole.

PROPIONIC ACID (excluding its salts and derivatives) in preparations containing 80 per cent or less of propionic acid, except:

(a) in preparations containing 30 per cent or less of propionic acid; or

PROPOXUR:

(a) when impregnated in plastic resin strip material containing 10 per cent or less of propoxur;

(b) in dust preparations containing 3 per cent or less of propoxur;

(c) in granular sugar-based fly baits containing 1 per cent or less of propoxur, a dark colouring agent and a separate bittering agent;

(d) in pressurised spray packs containing 10 g or less of propoxur; or

(e) in printed paper sheets for pest control containing 0.5 per cent or less of propoxur and in any case not more than 100 mg of propoxur per sheet.

PROPYZAMIDE.

PROTHIOCONAZOLE-DESCHLORO except in preparations containing 0.5 per cent or less of prothioconazole-deschloro.

PROTHIOCONAZOLE-TRIAZOLIDINETHIONE except in preparations containing 0.5 per cent or less of prothioconazole-triazolidinethione.

PYMETROZINE.

PYRACLOSTROBIN.

PYRAFLUFEN-ETHYL.

PYRASULFOTOLE.

PYRETHRINS, naturally occurring, being pyrethrolone, cinerolone or jasmolone esters of chrysanthemic or pyrethric acids except:

(a) in preparations for human therapeutic use; or

(b) in preparations containing 10 per cent or less of such substances.

PYRIDABEN in preparations containing 25 per cent or less of pyridaben.

PYRIFENOX.

PYRITHIOBAC SODIUM.

PYRITHIONE ZINC in paints containing 0.5 per cent or less of pyrithione zinc calculated on the non-volatile content of the paint except in paints containing 0.1 per cent or less of pyrithione zinc calculated on the non-volatile content of the paint.

QUATERNARY AMMONIUM COMPOUNDS in preparations containing 20 per cent or less of quaternary ammonium compounds except:

(b) dialkyl or dialkoyl quaternary ammonium compounds where the alkyl or alkoyl groups are derived from tallow or hydrogenated tallow or similar chain length (C16/C18) sources; or

(c) in preparations containing 5 per cent or less of such quaternary ammonium compounds.

QUINCLORAC.

QUININE in preparations for veterinary use containing 1 per cent or less of quinine.

QUINTOZENE.

QUIZALOFOP-P-ETHYL in aqueous preparations containing 40 per cent or less of quizalofop-p-ethyl.

RACTOPAMINE in animal feed premixes containing 10 per cent or less of ractopamine.

RESMETHRIN in preparations containing 10 per cent or less of resmethrin.

RIMSULFURON.

ROBENIDINE except in preparations containing 20 per cent or less of robenidine.

SALICYLANILIDE.

SELAMECTIN except in preparations containing 12 per cent or less of selamectin.

SETHOXYDIM.

SIDURON.

SILICOFLUORIDES in preparations containing 3 per cent or less of fluoride ion except:

(a) barium silicofluoride when separately specified in this Schedule; or

SINBIOALLETHRIN in preparations containing 10 per cent or less of sinbioallethrin except in preparations containing 1 per cent or less of sinbioallethrin.

SODIUM CHLORATE except in preparations containing 10 per cent or less of sodium chlorate.

SODIUM DIACETATE except in preparations containing 60 per cent or less of sodium diacetate.

SODIUM DODECYLBENZENE SULFONATE except in preparations containing 30 per cent or less of sodium dodecylbenzene sulfonate.

SODIUM HYDROGEN SULFATE except in preparations containing 10 per cent or less of sodium hydrogen sulfate.

SODIUM HYDROSULFITE when packed for domestic use except in preparations containing 10 per cent or less of sodium hydrosulfite.

† SODIUM HYDROXIDE (excluding its salts and derivatives) in preparations containing 5 per cent or less of sodium hydroxide being:

(a) solid preparations the pH of which in a 10 g/L aqueous solution is more than 11.5; or

(b) liquid or semi-solid preparations the pH of which is more than 11.5 except in food additive preparations for domestic use.

SODIUM LAURETH-6 CARBOXYLATE except in preparations containing 1 per cent or less of sodium laureth-6 carboxylate.

SODIUM METABISULPHITE when packed for domestic use except in preparations containing 10 per cent or less of sodium metabisulphite.

SODIUM NITRITE in preparations containing 1 per cent or less of sodium nitrite except:

(a) in preparations containing 0.5 per cent or less of sodium nitrite;

(b) when present as an excipient in preparations for therapeutic use; or

(c) in aerosols.

SODIUM PERCARBONATE (CAS No. 15630-89-4) in preparations containing 35 per cent or less of sodium percarbonate except in preparations containing 15 per cent or less of sodium percarbonate.

SODIUM POLYSTYRENE SULPHONATE in preparations for cosmetic use except in preparations containing 10 per cent or less of sodium polystyrene sulphonate.

SODIUM STANNATE except in preparations for cosmetic use containing 1 per cent or less of sodium stannate.

SODIUM SULFIDE in preparations for metal treatment in containers each containing 50 g or less of sodium sulfide.

SPINETORAM.

SPINOSAD except in aqueous suspensions containing 25 per cent or less of spinosad.

STAR ANISE OIL except:

(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 50 mL or less fitted with a restricted flow insert, and labelled with the warning:

(c) in preparations containing 50 per cent or less of star anise oil.

STYRENE (excluding its derivatives).

SULFACETAMIDE when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

SULFADIAZINE when packed and labelled for treatment of ornamental caged birds or ornamental fish only.

SULFADIMIDINE when packed and labelled for treatment of ornamental caged birds or ornamental fish only.

SULFAMERAZINE when packed and labelled for treatment of ornamental caged birds or ornamental fish only.

SULFAMIC ACID (excluding its salts and derivatives) in preparations containing 10 per cent or less of sulfamic acid (H3NO3S).

SULFATHIAZOLE when packed and labelled for treatment of ornamental caged birds or ornamental fish only.

SULFOMETURON-METHYL.

† SYMPHYTUM spp. (Comfrey) for dermal use.

2,3,6-TBA.

TDE (1,1-dichloro-2,2-bis[4-chlorophenyl]ethane) in preparations containing 10 per cent or less of TDE.

TEBUCONAZOLE.

TEBUFENOZIDE.

TEFLUTHRIN in preparations containing 2 per cent or less of tefluthrin.

TEMEPHOS:

(a) in liquid preparations containing 10 per cent or less of temephos;

(b) in powders containing 2 per cent or less of temephos; or

(c) in preparations containing 40 per cent or less of temephos when packed in single use containers having a capacity of 2 mL or less.

TEPRALOXYDIM.

TERBUTRYN.

TETRACHLOROETHYLENE in preparations containing 5 per cent or less of tetrachloroethylene except:

(b) in preparations for the treatment of animals; or

(c) when absorbed into an inert solid.

TETRACHLORVINPHOS except in animal feeds containing 0.2 per cent or less of tetrachlorvinphos.

TETRACONAZOLE in preparations containing 20 per cent or less of tetraconazole.

TETRACYCLINE in preparations:

(b) containing 40 per cent or less of tetracycline when packed and labelled for the treatment of ornamental caged birds or ornamental fish only.

TETRAMETHRIN [(R, cis): (R, trans) = 20:80] except in pressurised spray packs.

THIABENDAZOLE:

(a) for the treatment of animals; or

(b) when packed and labelled for use as a fungicide except in preparations containing 50 per cent or less of thiabendazole.

THIAMETHOXAM in preparations containing 60 per cent or less of thiamethoxam.

THIAZOPYR.

THIFENSULFURON.

THIOBENCARB.

THIODICARB in pelleted preparations containing 1.5 per cent or less of thiodicarb.

THIOPHANATE-METHYL in preparations containing 25 per cent or less of thiophanate-methyl.

THYME OIL except:

(a) in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Required Advisory Statements for Medicine Labels;

(b) in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

(c) in preparations containing 50 per cent or less of thyme oil.

TIOCARBAZIL.

TOLCLOFOS-METHYL.

TOLTRAZURIL.

TRALKOXYDIM.

TRENBOLONE in implant preparations for growth promotion in animals.

TRIADIMEFON in wettable powders containing 25 per cent or less of triadimefon.

TRIADIMENOL.

TRI-ALLATE.

TRIBENURON-METHYL.

TRICHLOROACETIC ACID, alkali salts of.

† 1,1,1-TRICHLOROETHANE except:

(a) in preparations packed in pressurised spray packs;

(b) in preparations containing 25 per cent or less of designated solvents;

(c) in preparations, other than writing correction fluids or thinners for writing correction fluids, in containers having a capacity of 50 mL or less; or

(d) in writing correction fluids or thinners for writing correction fluids, in containers having a capacity of 50 mL or less labelled with:

(i) the word “Trichloroethane” written in letters not less than 1 mm in height and in distinct contrast to the background; and

(ii) the expression:

WARNING - DO NOT DELIBERATELY SNIFF THIS PRODUCT. SNIFFING MIGHT HARM OR KILL YOU;

written in bold face sans serif capital letters not less than 1 mm in height and in distinct contrast to the background.

TRIDIPHANE.

TRIETAZINE.

TRIETHANOLAMINE (excluding its salts and derivatives) except in preparations containing 5 per cent or less of triethanolamine.

TRIFLOXYSTROBIN.

TRIFLUMIZOLE.

TRIFLUMURON.

TRIISOPROPANOLAMINE LAURYL ETHER SULFATE except in preparations containing 30 per cent or less of triisopropanolamine lauryl ether sulfate when labelled with the statements:

Avoid contact with eyes and skin; and

Wash hands after handling.

TRINEXAPAC-ETHYL except:

(a) when packed in a sealed water-soluble measure pack; or

(b) in solid preparations containing 25 per cent or less of trinexapac-ethyl in packs of 50 g or less.

3,6,9-TRIOXAUNDECANEDIOIC ACID except in preparations containing 5 per cent or less of 3,6,9-trioxaundecanedioic acid, the pH of which is 3.5 or greater.

TRITICONAZOLE.

TURPENTINE OIL except in preparations containing 25 per cent or less of turpentine oil.

TYLOSIN in animal feed premixes containing 5 per cent or less of antibiotic substances:

(a) for growth promotion;

(b) for the prevention of liver abscesses in cattle; or

(c) for the prevention of ileitis in pigs.

VIRGINIAMYCIN in animal feed additives containing 1 per cent or less of virginiamycin for the prevention of laminitis in horses when in a pack of 5 kg or less.

VERNOLATE.

WARFARIN in rodent baits containing 0.1 per cent or less of warfarin.

ZINEB.