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.

Alimemazine when combined with one or more other therapeutically active substances in solid oral preparations when—

• (a)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
• (b)in a day-night pack containing alimemazine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

except in preparations for the treatment of children under 2 years of age.

Aloxiprin.

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 schedules 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 labelling requirements under the Act;
• (c)in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when—
  • (i)packed in blister or strip packaging or in a container with a child-resistant closure;
  • (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 labelling requirements under the Act; or
• (d)in tablets or capsules each containing no other therapeutically active constituent other than an effervescent agent when—
  • (i)packed in blister or strip packaging or in a container with a child-resistant closure;
  • (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 labelling requirements under the Act.

Atropa belladonna (belladonna)—

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

• (a)in preparations for nasal use;
• (b)in topical eye preparations containing 0.05 per cent or less of azelastine.

Beclometasone in aqueous nasal sprays delivering 50 μg or less of beclometasone per actuation when the maximum recommended daily dose is no greater than 400 μg 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—

• (a)in preparations for dermal use;
• (b)in divided topical oral preparations containing 3 mg or less of benzydamine; or
• (c)in undivided topical oral preparations containing 0.3 per cent or less of benzydamine in a primary pack containing not more than 50 ml.

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
• (b)in preparations for the treatment of tinea pedis.

Bromhexine.

Brompheniramine when combined with one or more other therapeutically active substances in oral preparations when—

• (a)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
• (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,

except in preparations for the treatment of children under 2 years of age.

Budesonide in aqueous nasal sprays delivering 64 μg or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 μg, 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 except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when—

• (a)in a primary pack containing not more than 10 days’ supply; and
• (b)labelled with a recommended daily dose not exceeding 10 mg of cetirizine.

Chlophedianol.

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

Chloroform in preparations for therapeutic use except—

• (a)when included in Schedule 4; or
• (b)in preparations containing 0.5 per cent or less of chloroform.

Chlorphenamine when combined with one or more other therapeutically active substances in oral preparations when—

• (a)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
• (b)in a day-night pack containing chlorphenamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

except in preparations for the treatment of children under 2 years of age.

Ciclopirox—

• (a)in preparations for dermal use containing 2 per cent or less of ciclopirox except in preparations for the treatment of tinea pedis; or
• (b)in preparations for application to the nails containing 8 per cent or less of ciclopirox.

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.

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 the schedules to these Regulations.

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.

Dexchlorphenamine when combined with one or more other therapeutically active substances in oral preparations when—

• (a)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
• (b)in a day-night pack containing dexchlorphenamine in the bed-time dose where the day and night doses are in the same immediate container or immediate wrapper,

except in preparations for the treatment of children under 2 years of age.

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 when—

• (a)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;
• (b)in preparations for dermal use containing 4 per cent or less of diclofenac except in preparations for dermal use containing 2 per cent or less of diclofenac or for the treatment of solar keratosis; or
• (c)in transdermal preparations for topical use containing 140 mg or less of diclofenac.

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—
  • (i)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
  • (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,

except in preparations for the treatment of children under 2 years of age.

Doxylamine when combined with one or more other therapeutically active substances in oral preparations when—

• (a)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
• (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,

except in preparations for the treatment of children under 2 years of age.

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.

Esomeprazole in oral preparations containing 20 mg or less 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.

Etafedrine.

Ether for therapeutic use except—

• (a)when included in Schedule 4; or
• (b)in preparations containing 10 per cent or less of ether.

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 except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when—

• (a)in a primary pack containing 20 dosage units or less and not more than 10 days’ supply; and
• (b)labelled with a recommended daily dose not exceeding 120 mg of fexofenadine.

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 with a child-resistant closure—
  • (i)for therapeutic use 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 labelling requirements under the Act;
  • (ii)for non-therapeutic use when labelled with warnings to the following effect—
    • (A)“DO NOT SWALLOW”; and
    • (B)“DO NOT USE (THIS PRODUCT/INSERT NAME OF PRODUCT) IN CHILDREN 6 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—

   

  (AA) “DO NOT SWALLOW”; and

   

  (BB) “DO NOT USE (THIS PRODUCT/INSERT NAME OF

  PRODUCT) IN CHILDREN 6 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 propionate (excluding its derivatives) in aqueous nasal sprays delivering 50 μg or less of fluticasone per actuation when the maximum recommended daily dose is no greater than 400 μg, 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—

• (a)when included in Schedule 4; or
• (b)in preparations containing 500 μg or less of folic acid per recommended daily dose.

Folinic acid for human therapeutic use except—

• (a)when included in Schedule 4; or
• (b)in preparations containing 500 μg 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.

Gelsemium sempervirens.

Glutaral for human therapeutic use.

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

Hexachlorophene in preparations for human use containing 3 per cent or less of hexachlorophene except—

• (a)in preparations for use on infants, as specified in Schedule 4;
• (b)in preparations for cosmetic use, as specified in Schedule 6; or
• (c)in other preparations containing 0.75 per cent or less of hexachlorophene.

Hydrocortisone and hydrocortisone acetate, but excluding other salts and derivatives, in preparations for human therapeutic use—

• (a)for dermal use in preparations containing 0.5 per cent or less of hydrocortisone, in packs containing 30 g or less of such preparations, containing no other therapeutically active constituent other than an antifungal substance;
• (b)for dermal use in preparations containing 1 per cent or less of hydrocortisone, in packs containing 15 g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent—
  • (i)for the treatment of tinea (tinea pedis, tinea cruris, tinea corporis) and other fungal skin infections; and
  • (ii)not labelled for the treatment of children under 12 years of age; or
• (c)for rectal use in preparations containing 0.5 per cent or less of hydrocortisone, 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 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—

• (a)in hair preparations containing 0.3 per cent or less of hydroquinone; or
• (b)in cosmetic nail preparations containing 0.02 per cent or less of hydroquinone.

Hyoscine—

• (a)for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or
• (b)for oral use—
  • (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
• (b)for oral use—
  • (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 8 g 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)it is the only therapeutically active constituent (other than phenylephrine or when combined with 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)compliant with the labelling requirements under the Act;
  • (v)not labelled for the treatment of children 6 years of age or less; and
  • (vi)not labelled for the treatment of children under 12 years of age when combined with phenylephrine.

Indanazoline.

Indometacin in preparations for external use containing 1 per cent or less of indometacin.

Iodine—

• (a)in preparations for human internal therapeutic use containing 300 μg 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—

• (a)when included in Schedule 4; or
• (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
• (b)in preparations for the treatment of tinea pedis.

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

Lansoprazole in oral preparations 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 7 days’ supply.

Levocabastine in topical eye or nasal preparations.

Levocetirizine in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis in adults and children 12 years of age and over when—

• (a)in a primary pack containing not more than 5 days’ supply; and
• (b)labelled with a recommended daily dose not exceeding 5 mg of levocetirizine.

Lidocaine in preparations for topical use other than eye drops—

• (a)containing 10 per cent or less of total local anaesthetic substances, except—
  • (i)in dermal preparations containing 2 per cent or less of total local anaesthetic substances; or
  • (ii)in aqueous sprays for oromucosal use containing 0.6 per cent or less of total local anaeasthetic substances; or
• (b)in divided preparations containing 200 mg or less of total local anaesthetic substances, 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 inflate 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 except in preparations containing 2 mg or less of loperamide per dosage unit, in a primary pack containing 8 dosage units or less.

Loratadine in preparations for oral use except in divided preparations for the treatment of seasonal allergic rhinitis when—

• (a)in a primary pack containing 10 dosage units or less when labelled for adults and children 6 years of age and over; and
• (b)labelled with a recommended daily dose not exceeding 10 mg of loratadine.

Macrogols in preparations for oral use as a liquid concentrate for laxative 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 except when included in Schedule 6.

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 μg or less of mometasone per actuation when the maximum recommended daily dose is no greater than 200 μg for the prophylaxis or treatment of allergic rhinitis for up to 6 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.

Nicotine for use as an aid in withdrawal from tobacco smoking in preparations for oromucosal or transdermal use.

Niclosamide for human therapeutic use.

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

Noscapine.

Nystatin in dermal preparations.

Omeprazole in oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 7 days’ supply.

Oxetacaine (oxethazaine) in preparations for internal use.

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

Oxymetazoline.

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

Papaverine except when included in Schedule 4.

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 7 days’ supply.

Paracetamol for therapeutic use—

• (a)in liquid preparations for oral use containing a maximum of 10 g of paracetamol per container;
• (b)in tablets or capsules enclosed in a primary pack containing not more than 100 tablets or capsules;
• (c)in individually wrapped powders or sachets of granules enclosed in a primary pack containing not more than 50 wrapped powders or sachets of granules; or
• (d)in other preparations except—
  • (i)when included in schedules 3 or 4;
  • (ii)in individually wrapped powders or sachets of granules each containing 1000 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when—
    • (A)enclosed in a primary pack that contains not more than 10 such powders or sachets of granules;
    • (B)compliant with the labelling requirements under the Act;
    • (C)not labelled for the treatment of children 6 years of age or less; and
    • (D)not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin; or
  • (iii)in tablets or capsules each containing 500 mg or less of paracetamol as the only therapeutically active constituent (other than caffeine, phenylephrine and/or guaifenesin or when combined with effervescent agents) when—
    • (A)packed in blister or strip packaging or in a container with a child-resistant closure;
    • (B)in a primary pack containing not more than 20 tablets or capsules;
    • (C)compliant with labelling requirements under the Act;
    • (D)not labelled for the treatment of children 6 years of age or less; and
    • (E)not labelled for the treatment of children under 12 years of age when combined with caffeine, phenylephrine and/or guaifenesin.

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.

Phedrazine.

Phenazone for human external use.

Pheniramine—

• (a)in eye drops; or
• (b)when combined with one or more therapeutically active substances in oral preparations when—
  • (i)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
  • (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,

except in preparations for the treatment of children under 2 years of age.

Phenol, or any homologue boiling below 220°c, for human therapeutic use except—

• (a)when included in Schedule 4; or
• (b)in preparations for external use containing 1 per cent or less of phenol and in preparations for external use containing 3 per cent or less of cresols and xylenols and other homologues of phenol.

Phenylephrine except—

• (a)when included in Schedule 4;
• (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—
  • (i)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
  • (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,

except in preparations for the treatment of children under 2 years of age.

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 labelling requirements under the Act.

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 7 days’ supply.

Ranitidine in preparations supplied in the manufacturer’s original pack containing not more than 14 days’ supply except—

• (a)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; or
• (b)in divided preparations for oral use containing 300 mg or less of ranitidine per dosage unit in the manufacturer’s original pack containing not more than 7 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 μg 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 labelling requirements under the Act; 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.

Tetracaine 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.

Tetrachloroethylene for human therapeutic use.

Tetryzoline.

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

Triprolidine when combined with one or more other therapeutically active substances in oral preparations when—

• (a)at least one of the other therapeutically active substances is a sympathomimetic decongestant; or
• (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,

except in preparations for the treatment of children under 2 years of age.

Tuaminoheptane.

Tymazoline.

Xylometazoline.

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