Adrenaline in preparations containing 1 per cent or less of adrenaline except in preparations containing 0.02 per cent or less of adrenaline unless packed and labelled for injection.

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.

Alimemazine—

• (a)in solid oral preparations except when included in Schedule 2; or
• (b)in liquid oral preparations containing 10 mg or less of alimemazine per 5 ml,

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

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

Astodrimer sodium except in a condom lubricant.

Azatadine in oral preparations.

Brompheniramine in oral preparations except—

• (a)when included in Schedule 2; or
• (b)for the treatment of children under 2 years of age.

Buclizine in oral preparations.

Butoconazole in preparations for vaginal use.

Chloramphenicol for ophthalmic use only.

Chlorbutanol in preparations for human use except—

• (a)when included in Schedule 2; or
• (b)in preparations containing 0.5 per cent or less of chlorbutanol.

Chlorphenamine in oral preparations except—

• (a)when included in Schedule 2; or
• (b)for the treatment of children under 2 years of age.

Ciclopirox in preparations for dermal use and for application to the nails except—

• (a)when included in Schedule 2; or
• (b)in preparations for the treatment of tinea pedis.

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.

Cyclizine in divided preparations for oral use in primary packs containing 6 dosage units or less.

Cyproheptadine in oral preparations.

Dexchlorphenamine in oral preparations except—

• (a)when included in Schedule 2; or
• (b)for the treatment of children under 2 years of age.

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 indicated for cough suppression and compounded with one or more other therapeutically active substances—

• (a)in divided preparations containing 10 mg or less of dihydrocodeine 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.

Diiodohydroxyquinoline (iodoquinol) for vaginal use.

Dimenhydrinate in oral preparations except when included in Schedule 2.

Dimethindene in oral preparations.

Diphenhydramine in oral preparations except—

• (a)when included in Schedule 2; or
• (b)for the treatment of children under 2 years of age.

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—

• (a)when included in Schedule 2; or
• (b)for the treatment of children under 2 years of age.

Econazole in preparations for vaginal use.

Erythrityl tetranitrate for therapeutic use.

Famciclovir for oral use, in divided preparations containing a total dose of 1500 mg or less of famciclovir for the treatment of herpes labialis (cold sores).

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 labelling requirements under the Act;
  • (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—
    • (A)“DO NOT SWALLOW”; and
    • (B)“DO NOT USE [THIS PRODUCT/NAME OF PRODUCT] IN CHILDREN 6 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 dermal use, in packs containing 2 g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) in adults and adolescents (12 years of age and over); or
• (c)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;

except when included in Schedule 2.

Ibuprofen—

• (a)in divided preparations, each containing 400 mg or less of ibuprofen in a primary pack containing not more than 50 dosage units, when labelled—
  • (i)with a recommended daily dose of 1200 mg or less of ibuprofen; and
  • (ii)not for the treatment of children under 12 years of age; or
• (b)in a modified release dosage form, each containing 600 mg of ibuprofen in a primary pack containing not more than 32 dosage units, when labelled—
  • (i)with a recommended daily dose of 1200 mg or less of ibuprofen; and
  • (ii)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 except when included in Schedule 2.

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.

Naloxone when used for the treatment of opioid overdose.

Naproxen in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age.

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 symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days’ supply except when included in Schedule 2.

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 except when included in Schedule 2.

Paracetamol—

• (a)when combined with ibuprofen in a primary pack containing 30 dosage units or less or;
• (b)when combined with ibuprofen in preparations for oral use when labelled with a recommended daily dose of 1200 mg or less of ibuprofen in divided doses in a primary pack containing no more than 12 dosage units per pack; or
• (c)in liquid preparations for oral use except when included in Schedule 2.

Pheniramine in oral preparations except—

• (a)when included in Schedule 2; or
• (b)for the treatment of children under 2 years of age.

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—

• (a)when included in Schedule 2; or
• (b)in preparations for the treatment of children under 2 years of age.

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 except when included in Schedule 2.

Salbutamol as the only therapeutically active substance—

• (a)in metered aerosols delivering 100 μg or less of salbutamol per metered dose; or
• (b)in dry powders for inhalation delivering 200 μg 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 μg or less of terbutaline per metered dose; or
• (b)in dry powders for inhalation delivering 500 μg 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.

Triprolidine in oral preparations except—

• (a)when included in Schedule 2; or
• (b)for the treatment of children under 2 years of age.

Ulipristal for emergency post-coital contraception.

Vitamin D for human internal therapeutic use in preparations containing 175 μg or less of vitamin D per recommended single weekly dose except in preparations containing 25 μg or less of vitamin D per recommended daily dose.