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Ingredient ATC Level 1 ATC Level 2 Year Of Switch Country Status Additional Information
Sucralfate A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1982 Australia OTC General sale.
Flavoxate hydrochloride G Genito urinary system and sex hormones. Genito urinary system and sex hormones G04. Urologicals 1986 Australia OTC Pharmacist-only (S3) medicine. No advertising to the general public permitted.
Tioconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1987 Australia OTC In 1987, rescheduled from S4 (prescription) to S3 (pharmacist only) for human use in preparations containing max 1% of tioconazole, for the treatment of fungal infections of the skin. Effective June 1999, S4 to S3 in preparations for vaginal use, and S3 to S2 (pharmacy only) switch in all preparations for dermal use, i.e. no strength limitation. Effective 1 January 2006, S2 to GSL switch for dermal preparations for the treatment of tinea pedis. The S3 indication for vaginal use cannot be advertised to consumers.
Loperamide A Alimentary tract and metabolism. Alimentary tract and metabolism A07. Antidiarrheals, intestinal antiinflammatory/antiinfective agents 1987 Australia OTC 1987: rescheduled from S4 (prescription) to S3 (pharmacist only) in packs of max 8 dosage units, each dosage unit containing max 2mg of loperamide. Switched in 1997 to S2 (pharmacy only) . In 2001, pack size increased to max 20 dosage units for oral use. Effective 1 May 2012, S2 to GSL switch for loperamide in small packs of up to 8 dosage units.
Benzydamine M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1987 Australia OTC Rescheduled from S4 (prescription) to S2 (pharmacy only) in preparations for topical use containing max 3% of benzydamine. In September 1999, this was amended to preparations for topical use. Effective September 2007, S2 to General Sale (GSL) switch for dermal preparations, i.e. preparations for application to the skin primarily for localised effect. Preparations for topical use remain in S2. Effective 1 June 2015, S2 to GSL switch for benzydamine in divided topical oral preparations containing 3mg or less of benzydamine (i.e. Benzydamine lozenges switched to GSL).
Dihydrocodeine N Nervous system. Nervous system N02. Analgesics 1987 Australia OTC Rescheduled from S4 (prescription) to S3 (pharmacist only) in 1987 when compounded with one or more other therapeutically active substances when: (a) in divided preparations containing max 10mg per dosage unit and with a recommended dose of max 15mg of dihydrocodeine, or (b) in undivided preparations containing max 0.25% of dihydrocodeine with a recommended dose of max 15mg of dihydrocodeine. Dihydrocodeine is also available as an S2 (pharmacy only) medicine when compounded with aspirin and no other therapeutically active substance in divided preparations: (a) containing max 5mgof 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 max 25 dosage units, and (d) labelled with a recommended dose of max 10mg of dihydrocodeine. The S3 presentations cannot be advertised to consumers. Note: apart from the cough/cold review, the following information applies to codeine-containing analgesics: As from May 2010 Codeine preparations for the treatment of coughs and colds are scheduled as pharmacy-only (S2) medicines only if they contain not more than six days of supply at specified maximum doses. To qualify as a Schedule 2 medicine, the product must have codeine combined with the decongestant phenylephrine. The maximum unit dose of codeine is 12mg, the maximum recommended daily dose of codeine is 100mg, and the maximum pack size is a five-day supply. Other coughs and cold preparations were switched from S2 to S3 (pharmacist-only) status. Moreover, all combination analgesic products containing more than five days of supply at specified maximum doses were switched from S3 to S4 status. The measures were taken as a result of concerns over the extraction of codeine for the manufacture of illicit drugs. In addition, combination analgesics containing codeine are no longer included in Appendix H (meaning they cannot be advertised). Further restrictions on codeine combinations for coughs and colds may still be introduced given that the misuse/abuse of Schedule 2 codeine combinations for coughs and colds was to be reviewed 12 months after the rescheduling of analgesic combinations took effect. Effective 2012, dihydrocodeine contraindicated in children aged 2 to 5 years of age, in children's cough and cold products. Products do not include dosing for the 2 to 5 year age group. Effective 1 October 2017, amended entry for dihydrocodeine, allowing use as S3 only 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.
Paracetamol + dihydrocodeine N Nervous system. Nervous system N02. Analgesics 1987 Australia OTC In 1987, rescheduled from S4 (prescription) to S3 (pharmacist only) when compounded with one or more other therapeutically active substances when: (a) in divided preparations containing max 10mg per dosage unit and with a recommended dose of max 15mg of dihydrocodeine, or (b) in undivided preparations containing max 0.25% of dihydrocodeine with a recommended dose of max 15mg of dihydrocodeine. Cannot be advertised to consumers. Effective 1 October 2017, the S2 entry for dihydrocodeine, which allowed for dihydrocodeine when compounded with aspirin (in limited pack size and strength), has been deleted. At the same time, amendments were made to the S3 and S4 entries for dihydrocodeine. There is no S2 entry for dihydrocodeine; The S3 entry is limited to use as a cough suppressant, and does not allow use as an analgesic.
Azatadine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1988 Australia OTC 1988: switch from Rx to S3 (pharmacist only) in oral preparations.
Nicotine (gum) N Nervous system. Nervous system N07. Other nervous system drugs 1988 Australia OTC With effect from 1 January 2012, all Nicotine preparations for oromucosal or transdermal use as an aid in withdrawal from tobacco smoking are available as unscheduled medicines (GSL).
Ibuprofen (oral) M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1989 Australia OTC Rescheduled from S4 (prescription) to S3 (pharmacist only) in 1989 as the only therapeutically active substance in divided preparations for oral use containing max 200mg of ibuprofen per dosage unit in a pack containing max 50 dosage units labelled with a recommended daily dose of max 1200mg of ibuprofen. Rescheduled from S3 to S2 (pharmacy only) in December 1995 as the only therapeutically active substance in divided preparations for oral use containing max 200mg of ibuprofen per dosage unit in a pack containing max 50 dosage units labelled with a recommended daily dose of max 1200mg of ibuprofen. In March 1999, rescheduled from S4 to S2 in divided preparations for oral use containing max 200mg per dosage unit of ibuprofen in a pack containing max 50 labelled with a recommended daily dose of max 1200mg of ibuprofen (i.e. no longer as the only therapeutically active substance). Effective June 1999, S4 to S3 switch for undivided preparations for oral use labelled with a recommended daily dose of max 1200mg of ibuprofen. In September 1999, liquid and combination preparations rescheduled from S3 to S2: - in divided preparations for oral use containing max 200mg per dosage unit in a pack containing max 100 dosage units labelled with a recommended daily dose of max 1200mg of ibuprofen (NB: larger pack size permitted also); - in liquid preparations for oral use which are sold in the manufacturer's original pack having a capacity of max 200ml and in strengths of max 100mg/5ml (NB: later changed to max 4g). Effective January 2004, S2 to exempt from scheduling status (GSL) for single ingredient blister/strip/CRC closure packs of ibuprofen, each containing 200mg of ibuprofen and in packs containing max 25 dosage units when labelled as required. Effective September 2005, standardised label warnings (statements 101 and 104) added to GSL, S2 and S3 entries. Effective September 2006, S3 entry amended to allow for a 400mg dosage unit (compared with a 200mg dosage unit in S2 and GSL): Ibuprofen in divided preparations, each containing max 400mg of ibuprofen, in a primary pack containing max 50 dosage units when labelled: (a) with a recommended daily dose of 1200mg 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. Effective January 2007, unscheduled packs of ibuprofen must not be labelled for the treatment of children under the age of 6. Effective September 2011, S4 to S2 switch of liquid preparations up to 8g of ibuprofen. Effective September 2011, new entry S3: Paracetamol when combined with ibuprofen in a primary pack containing not more than 30 dosage units. Effective 1 January 2013, S2 to GSL switch for ibuprofen when in divided preparations containing max 200mg of ibuprofen in fixed dose combinations with phenylephrine in packs containing max 25 tablets. The S3 ibuprofen products cannot be advertised to consumers. Effective 1 June 2016, S3 to S2 switch for paracetamol 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 not more than 12 dosage units per pack. Effective 1 October 2017, new S3 and Appendix H entry for a modified release dosage form, each containing 600 mg of ibuprofen in a primary pack containing not more than 32 dosage units
Naproxen M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1990 Australia OTC Rescheduled from S3 (pharmacist only) to S2 (pharmacy only) in 1990 as the only therapeutically active substance in packs of max 12 dosage units for the treatment of spasmodic dysmenorrhoea. Effective June 1999, S4 (prescription) to S2 switch to allow for larger pack sizes and combinations permitted as S2 for the treatment of primary dysmenorrhoea i.e. naproxen in divided preparations containing max 250mg of naproxen per dosage unit in packs of max 20 dosage units for the treatment of dysmenorrhoea. Also in June 1999, rescheduled from S4 to S3 in divided preparations containing max 250mg of naproxen per dosage unit in packs of max 30 dosage units except when included in S2 for dysmenorrhoea (Otherwise Rx e.g. dermal or rectal application). Effective 1 July 2000, S3 to S2 switch in divided preparations containing max 250mg of naproxen per dosage unit in packs of max 30 dosage units. Effective 1 October 2014, new S3 entry for naproxen in a modified release dosage form of 600mg 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.
Cromoglicic acid R Respiratory system. Respiratory system R01. Nasal preparations 1990 Australia OTC Switched in 2000: ophthalmic preparations S4 until March 2000. Effective 17 March 2000, S2 in preparations for nasal or ophthalmic use. (Note: nasal preparations for topical use were switched from S3 to S2 in 1990).
Nystatin D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1990 Australia OTC Rescheduled to S3 (pharmacist only) in 1990 in treatments for topical use for treatment of candidal infections only. In March 1997, the S3 entry was amended to 'preparations for topical use', and preparations for dermal use rescheduled to S2 (pharmacy only). Nystatin preparations in S3 (topical use) may be advertised to consumers.
Miconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1990 Australia OTC Rescheduled from S3 (pharmacist only) to S2 (pharmacy only) in 1990 for human use in preparations containing max 2% of miconazole for the treatment of fungal infections of the skin. In June 1997, this entry was amended to apply to all dermal preparations for human use. In May 2006, the S2 entry was further amended to clarify that this schedule also covered miconazole application to the nails. Switched to S3 in 1994 in topical preparations for vaginal use and when containing max 2% of miconazole for the treatment of oral candidiasis. In June 1999, concentration limitation removed i.e. miconazole for human use in topical preparations for treatment of oral candidiasis, or for vaginal use. Effective 1 January 2006, S2 to GSL switch for dermal preparations for the treatment of tinea pedis. The S3 indications for miconazole, i.e. oral candidiasis and vaginal use, may be advertised to consumers.
Clotrimazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1991 Australia OTC In 1991, switched to S2 (pharmacy only) for human use in topical preparations containing max 1% of clotrimazole, for the treatment of fungal infections of the skin. In 1997, this was amended to all dermal preparations for human use. Effective 1 January 2006, switched from S2 to GSL status for dermal preparations in the treatment of tinea pedis. Indication for the treatment of nails included in S2 entry from 1 January 2007.
Mefenamic acid M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1992 Australia OTC In 1992, rescheduled from S3 (pharmacist only) to S2 (pharmacy only) as the only therapeutically active substance in packs of max 30 dosage units for the treatment of spasmodic dysmenorrhoea. In September 1999, entry changed to divided preparations for oral use in packs of max 30 for treatment of dysmenorrhoea.
Prilocaine N Nervous system. Nervous system N01. Anesthetics 1993 Australia OTC In December 1993, rescheduled from S4 (prescription) to S2 (pharmacy only) in preparations for topical use, other than eye drops, containing max 10% of local anaesthetic substances. Effective January 2006, entry amended to refer to 'dermal use' rather than 'topical use'.
Indomet(h)acin M Musculo-skeletal system. Musculo-skeletal system M01. Antiinflammatory and antirheumatic products 1994 Australia OTC Switched in 1994 from S4 (prescription) to S2 (pharmacy only) as the only therapeutically active in spray preparations for external use containing max 1% of indomethacin. Effective March 2000: S2 entry extended to preparations for external use containing max 1% of indomethacin. Indomethacin for oral use is Rx.
Miconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1994 Australia OTC In 1994, switched from S4 (prescription) to S3 (pharmacist only) in topical preparations for vaginal use and when containing max 2% of miconazole for the treatment of oral candidiasis. Effective June 1999, concentration limitation removed i.e. miconazole for human use in topical preparations for treatment of oral candidiasis, or for vaginal use. May be advertised to consumers.
Econazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1994 Australia OTC S2 (pharmacy only) in dermal preparations (Rx to S3 (pharmacist only) and S2 in stages (1994-1997)). Effective 1 January 2006, S2 to GSL switch in dermal preparations for the treatment of tinea pedis.
Clotrimazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1994 Australia OTC Rescheduled from S4 (prescription) to S3 (pharmacist only) in preparations for vaginal use in 1994. May be advertised to consumers.
Ketoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1994 Australia OTC In 1994, ketoconazole was rescheduled to S3 (pharmacist only) for human use in topical preparations containing max 2% of ketoconazole, for the treatment of fungal infections of the skin. In 1997, it was rescheduled to S2 (pharmacy only) for human use in dermal preparations. In September 1999, preparations containing max 1% for the treatment of the scalp were exempted from scheduling (GSL). Effective 1 January 2006, dermal preparations for the treatment of tinea pedis were exempted from scheduling.
Cimetidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1995 Australia OTC Switched from S4 (prescription) to S3 (pharmacist only, advertising not allowed) in July 1995 for the relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 22 June 1997, dosage restriction and divided preparation controls removed (i.e. as the only therapeutically active substance in preparations for oral use for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply). Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in a primary pack containing not more than 14 days supply. Effective 1 January 2006, the indication "for the relief of symptoms of gastro-oesophageal reflux" was deleted from the S3 entry, i.e. "in a primary pack containing no more than 14 days' supply".
Hyoscine butylbromide A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders 1995 Australia OTC June 1995, S4 (prescription) to S3 (pharmacist only) switch as the only therapeutically active substance in divided preparations for oral use containing 10mg or less of hyoscine butylbromide per dosage unit in a pack containing maximum 20 dosage units. 18 March 1999, switched to S2 (pharmacy only). Effective February 2003, S2 entry amended to increase dosage per unit from 10mg to 20mg or less of hyoscine butylbromide, and the pack size from 20 or less dosage units to 200mg or less of hyoscine butylbromide.
Ranitidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1995 Australia OTC S3 (pharmacist only) as the only therapeutically active substance in preparations for oral use for the relief of symptoms of gastro-oesophageal reflux in packs containing not more than 14 days supply (Rx to S3 in stages (1995-1997)). Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply. S3 to S2 (pharmacy only) switch, effective 1 June 2001 'for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days' supply.' Effective 1 January 2006, the indication "for the relief of symptoms of gastro-oesophageal reflux" was deleted from the S2 entry, i.e. 'when sold in the manufacturer's original pack containing not more than 14 days' supply.' Effective 1 September 2007, switch to General Sale (GSL) for ranitidine in packs of less than 14 dosage units. "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 150mg or less of ranitidine per dosage unit in the manufacturer's original pack containing not more than 14 dosage units." Effective 1 October 2015, approval of switch to General Sale (GSL) for ranitidine in divided preparations for oral use containing 300mg or less of ranitidine per dosage unit (in the manufacturer’s original pack) containing not more than 7 dosage units.
Hydrocortisone (topical) D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1995 Australia OTC In December 1995, rescheduled from S4 (prescription) to S3 (pharmacist only) as the only other therapeutically active substance in combination with max 0.5% of cinchocaine for topical rectal use in packs of max 30g. In September 1999, rescheduled from S4 to S3 in preparations containing max 1% for dermal use in packs of max 30g containing no other therapeutically active substance other than an antifungal (except when in S2). Rescheduled from S3 to S2 (pharmacy only) in preparations for dermal use containing 0.5% of hydrocortisone in packs of max 30g with no other therapeutically active substance except an antifungal. Effective January 2008, new S2 entry: Hydrocortisone and hydrocortisone acetate, but excluding other salts and derivatives, in preparations containing max 0.5% hydrocortisone: (a) for dermal use, in packs containing max 30g of such preparations containing no other therapeutically active constituent other than an antifungal substance; (b) for rectal use when combined with a local anaesthetic substance but no other therapeutically active constituent except unscheduled astringents: - in undivided preparations in packs of max 35g, or - in packs containing max 12 suppositories. S3 entry: Hydrocortisone and hydrocortisone acetate, but excluding other salts and derivatives, in preparations containing max 1% of hydrocortisone: (a) for dermal use, in packs containing max 30g 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 but no other therapeutically active substance except unscheduled astringents: - in undivided preparations in packs of max 35g, or - in packs containing max 12 suppositories except when included in Schedule 2. S4: Hydrocortisone: (a) for human use except when included in Schedule 2 or 3, or (b) for the treatment of animals. S3: hydrocortisone single active ingredient products may be advertised to consumers. Also when in combination with unscheduled ingredients or with S3 antifungal ingredients. Effective 1 October 2015, Hydrocortisone for dermal use in preparations containing 1% or less of hydrocortisone for dermal use, in packs containing 2g 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 older). Effective 1 February 2016, S3 to S2 switch - Hydrocortisone for dermal use in preparations containing 1% or less of hydrocortisone, in packs containing 15g 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.
Nizatidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1995 Australia OTC S4 (prescription) until July 1995. As the only therapeutically active substance in divided preparations for oral use containing 200mg or less of nizatidine per dosage unit, for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 22 June 1997, dosage restriction and divided preparation controls removed i.e. as the only therapeutically active substance in preparations for oral use for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply. S3 (pharmacist only) to S2 (pharmacy only) switch, effective 1 March 2002 'for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days' supply.' Effective 1 January 2006, the indication 'for the relief of symptoms of gastro-oesophageal reflux' was deleted from the S2 entry, i.e. 'when sold in the manufacturer's original pack containing not more than 14 days supply'.
Famotidine A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1995 Australia OTC Switched from S4 (prescription) to S3 (pharmacist only) in 1995 as the only therapeutically active substance in divided preparations for oral use containing 200mg or less of famotidine per dosage unit, for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 22 June 1997, dosage restriction and divided preparation controls removed i.e. as the only therapeutically active substance in preparations for oral use for relief of symptoms of gastro-oesophageal reflux in a pack containing not more than 14 days supply. Effective 17 March 2000, 'as the only therapeutically active substance' control removed, i.e. for the relief of symptoms of gastro-oesophageal reflux, in packs containing not more than 14 days supply. Switched to S2 (pharmacy only) effective 1 June 2001 'for the relief of symptoms of gastro-oesophageal reflux in packs containing not more than 14 days' supply'. Effective 1 January 2006, the indication 'for the relief of symptoms of gastro-oesophageal reflux' was deleted from the S2 entry, i.e. 'when sold in the manufacturer's original pack containing not more than 14 days' supply.'
Sulfacetamide (topical) S Sensory organs. Sensory organs S01. Ophthalmologicals 1996 Australia OTC S3 in preparations for ophthalmic use containing 10% or less of sulfacetamide (Rx to S3 (1996)).
Triamcinolone D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 1996 Australia OTC Effective September 2004, S3 (pharmacist only) to S2 (pharmacy only) switch for aqueous nasal sprays (ATC code R01) delivering max 55 micrograms of triamcinolone per actuation when the maximum recommended daily dose is max 220 micrograms and when packed in a primary pack containing max 120 actuations, for prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over. (Effective 1 September 2006, the limit on number of actuations removed from the S2 entry.) Effective September 1996, S4 (prescription) to S3 (pharmacist only) switch for triamcinolone for the treatment of mouth ulcers (ATC code A01), in preparations containing max 0.1% of triamcinolone. Entry amended effective 1 May 2007 to triamcinolone for buccal use in preparations containing max 0.1% of triamcinolone in a pack of max 5g. Cannot be advertised to consumers.
Aciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 1996 Australia OTC Effective December 1996, switched from S4 (prescription) to S2 (pharmacy only) in preparations containing max 5% of aciclovir for external use for the treatment of herpes labialis in packs containing max 10g. Effective June 2002, these preparations were switched to general sale (i.e., S2 entry deleted). All other aciclovir preparations are scheduled S4. Effective 1 October 2015, new Schedule 3 (pharmacist only) entry - hydrocortisone in combination with aciclovir for dermal use, in packs containing 2g or less of such preparations, containing no other therapeutically active constituent other than aciclovir (5% w/w or less) for use in adults and adolescents (12 years of age and older).
Idoxuridine (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 1996 Australia OTC Switched in 1996 from S3 (pharmacist only) to S2 (pharmacy only) in preparations containing max 0.5% of idoxuridine for dermal use. In September 1999, S2 to GSL switch for preparations containing 0.5% or less for dermal use.
Terbinafine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1996 Australia OTC Effective December 1996, switched from S4 (prescription) to S2 (pharmacy only) in topical preparations containing max 1% of terbinafine, for the treatment of fungal infections of the skin. Effective June 1999, limit on concentration removed. S2 in preparations for dermal use. Effective May 2007, switch from S2 to GSL for preparations for tinea pedis.
Diclofenac (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1997 Australia OTC Rescheduled from S4 (prescription) to S2 (pharmacy only) in September 1997, in preparations for dermal use containing max 1% of diclofenac. Effective September 2000, rescheduled from S2 to GSL in preparations for dermal use containing max 1% of diclofenac. Effective May 2012, S4 to S2 switch in preparations for dermal use containing max 4% of diclofenac, except in preparations for dermal use containing max 1% of diclofenac or for the treatment of solar keratosis. Effective May 2013, S4 to S2 switch in transdermal preparations for topical use containing max 140mg of diclofenac.
Cetirizine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1997 Australia OTC Switched in 1997: S4 until 19 December 1997. S3 as the only therapeutically active substance in divided preparations for oral use containing 10mg or less. Switched in 1998: in September 1998, liquid formulations permitted and dosage limitation removed. Entry modified to read as the only therapeutically active substance in oral preparations. Effective 1 January 2013, S2 to GSL switch, for divided oral doses used for the treatment of seasonal allergic rhinitis in adults and children over 12 years, when (a) in a primary pack containing not more than 5 days’ supply, and (b) labelled with a recommended daily dose not exceeding 10mg of cetirizine and unscheduled. Effective 1 June 2017, GSL pack size increased from 5 to 10 dosage units.
Levocetirizine R Respiratory system. Respiratory system R06. Antihistamines for systemic use 1997 Australia OTC Effective 1 February 2016, separate Levocetirizine entry in the Poisons Standard (i.e. scheduling is now separate from cetirizine). Levocetirizine entry reads: S2 (pharmacy only) 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 5mg of levocetirizine. (N.B This means that there is no general sale provision for levocetirizine following the separation of the entries).
Bifonazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1997 Australia OTC Switched from S4 (prescription) to S2 (pharmacy only) in 1997 for human use in dermal preparations. Effective 1 March 2002, S2 to GSL for preparations containing max 1% of bifonazole for the treatment of the scalp. Effective 1 January 2006, dermal preparations switched from S2 to GSL for the treatment of tinea pedis.
Nicotine (patch) N Nervous system. Nervous system N07. Other nervous system drugs 1997 Australia OTC Effective May 2004, nicotine chewing gum and transdermal patches switched from S2 (pharmacy only) to GSL. With effect from 1 January 2012, all Nicotine preparations for oromucosal or transdermal use as an aid in withdrawal from tobacco smoking are available as unscheduled medicines (GSL).
Econazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1997 Australia OTC S4 to S3 switch, for econazole in topical preparations for vaginal use, for treatment of vaginal candidiasis.
Penciclovir (topical) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 1998 Australia OTC In 1998, switched from S4 (prescription) to S2 (pharmacy only) in preparations for dermal use containing 1% or less of Penciclovir. In September 1999, the S2 entry was amended to include preparations for external use for the treatment of herpes labialis. Effective 1 October 2017, S2 to GSL switch for penciclovir in preparations containing 1 per cent or less of penciclovir for the treatment of herpes labialis in packs containing 10 g or less.
Minoxidil (topical) D Dermatologicals. Dermatologicals D11. Other dermatological preparations 1998 Australia OTC In September 1998, switched from S4 (prescription) to S3 (pharmacist only) in preparations for dermal use containing max 2% of minoxidil. All other preparations S4. Effective March 2000, S3 in preparations for dermal use containing max 5% of minoxidil. All other preparations S4. Effective March 2002, rescheduled from S3 to S2 (pharmacy only) when in preparations for dermal use containing max 5% of minoxidil.
Piroxicam (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1998 Australia OTC In 1998, switched from S4 (prescription) to S2 (pharmacy only) in dermal preparations containing max 0.5% of piroxicam. Effective March 2000, limit on concentration increased to max 1% of piroxicam for dermal preparations. Effective December 2000, S2 to unscheduled (GSL) status in preparations for dermal use containing max 1% of piroxicam. This was later changed to 'preparations for dermal use'.
Ibuprofen (topical) M Musculo-skeletal system. Musculo-skeletal system M02. Topical products for joint and muscular pain 1999 Australia OTC In September 1999, rescheduled from S4 (prescription) to S2 (pharmacy only) in preparations for external use. Effective May 2003, S2 to GSL switch in preparations for external use.
Isoconazole (vaginal) G Genito urinary system and sex hormones. Genito urinary system and sex hormones G01. Gynecological antiinfectives and antiseptics 1999 Australia OTC Schedule 3 (pharmacist only, advertising not permitted).
Nicotine (oral inhaler) N Nervous system. Nervous system N07. Other nervous system drugs 1999 Australia OTC Cartridges for oral inhalation containing max 10mg of nicotine per dosage unit were switched from S4 (prescription) to S3 (pharmacist only) in June 1999 and from S3 to S2 (pharmacy only) in September 2002. With effect from 1 January 2012, all Nicotine preparations for oromucosal or transdermal use as an aid in withdrawal from tobacco smoking are available as unscheduled medicines (GSL).
Nicotine (sublingual) N Nervous system. Nervous system N07. Other nervous system drugs 1999 Australia OTC With effect from 1 January 2012, all Nicotine preparations for oromucosal or transdermal use as an aid in withdrawal from tobacco smoking are available as unscheduled medicines (GSL).
Beclometasone (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 1999 Australia OTC Switched from S4 to S3 in 1999 in aqueous nasal sprays delivering 50 micrograms or less per actuation when the maximum recommended daily dose is no greater than 400 micrograms for the treatment of seasonal and allergic rhinitis. Switched from S3 to S2 effective 1 September 2003: beclometasone in aqueous nasal sprays delivering < 50 micrograms beclometasone per actuation when the maximum recommended daily dose is < 400 micrograms and when packed in a primary pack containing < 200 actuations, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years and over.
Miconazole & Hydrocortisone (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 1999 Australia OTC In September 1999, preparations for dermal use containing hydrocortisone or hydrocortisone acetate 1% in packs of 30g or less with no other therapeutically active substance except an antifungal for dermal use were switched to S3 (pharmacist only). Preparations for dermal use containing 0.5% of hydrocortisone or hydrocortisone acetate in packs of 30g or less with no other therapeutically active substance except an antifungal were switched to S2 (pharmacy only). Note: hydrocortisone, clotrimazole, econazole, miconazole, fluconazole and nystatin can be advertised to consumers. Effective 1 February 2016, new Schedule 2 entry for hydrocortisone 1% in combination with an antifungal, for dermal use in preparations containing 1% or less of hydrocortisone, in packs containing 15g or less of such preparations, containing an antifungal substance and no other therapeutically active constituent: i) for the treatment of tinea (tinea pedis, tinea cruis, tinea corporis) and other fungal skin infections; and ii) not labelled for the treatment of children under 12 years of age.
Budesonide (nasal) R Respiratory system. Respiratory system R01. Nasal preparations 1999 Australia OTC S3 to S2 effective 1 January 2004. 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 and over.
Ipratropium bromide R Respiratory system. Respiratory system R01. Nasal preparations 1999 Australia OTC Switched in September 1999 to Pharmacy (S2) medicine for use in nasal preparations.
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