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Ingredient ATC Level 1 ATC Level 2 Year Of Switch Country Status Additional Information
Selenium sulphide D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use — Australia OTC General sale in preparations for topical therapeutic use containing max 2.5% of selenium sulfide. Effective 1 January 2004, S4 (prescription) to S2 (pharmacy only) switch for topical preparations for human topical therapeutic use except in preparations containing max 3.5% of selenium sulfide (which are GSL). S4 to GSL for preparations containing between 2.5% and 3.5% of selenium sulphide.
Alclometasone (topical) D Dermatologicals. Dermatologicals D07. Corticosteroids, dermatological preparations 2000 Australia OTC Effective September 2000, rescheduled from S4 (prescription) to S3 (pharmacist only) as the only therapeutically active substance in preparations for dermal use containing 0.05% or less of alclomethasone (alclometasone) in packs containing 30g or less of the preparation. Cannot be advertised to consumers.
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.
Oxiconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2006 Australia OTC Effective 1 January 2006, S4 (prescription) to GSL switch for dermal preparations for the treatment of tinea pedis. Effective 1 September 2006, S4 to S3 (pharmacist only) switch for vaginal use and S4 to S2 switch for dermal preparations. Oxiconazole preparations for vaginal use cannot be advertised to consumers.
Hyaluronic acid (topical) D Dermatologicals. Dermatologicals D03. Preparations for treatment of wounds and ulcers — Australia OTC General sale.
Podofilox (Podophyllotoxin) D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use — Australia OTC S2 (pharmacy only) in preparations for external therapeutic use containing max 2% of podophyllotoxin. S3 (pharmacist only) in preparations for external therapeutic use containing more than 2% but not more than 4% of podophyllotoxin. In December 2001, S2 to S3 reverse switch for preparations containing more than 0.5% but not more than 1% of podophyllotoxin for the treatment of warts other than anogenital warts. Also, S2 to S4 (prescription) reverse switch for preparations containing more than 1% of podophyllotoxin for the treatment of warts. No advertising to consumers is permitted.
Isoconazole (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use — Australia OTC S2 (pharmacy only) in dermal preparations (Otherwise Rx).
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.
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.
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.
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.
Tolnaftate D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use — Australia OTC General sale.
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.
Calcium carbonate A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders — Australia OTC General sale.
Fluconazole D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2004 Australia OTC No topical use, only oral use.
Ubidecarenone C Cardiovascular system. Cardiovascular system C01. Cardiac therapy — Australia OTC General sale.
Lansoprazole A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 2010 Australia OTC S4 (prescription) to S3 (pharmacist only) on 1 September 2010 in oral preparations containing 15mg 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. In 2016, approval of Appendix H entry for Lansoprazole, allowing direct-to-consumer advertising.
Fluoride (sodium) A Alimentary tract and metabolism. Alimentary tract and metabolism A01. Stomatological preparations — Australia OTC Effective September 2008: - max. 15mg/kg fluoride ion provided general exemption from scheduling - reduce the Schedule 4 (prescription) to Schedule 2 (pharmacy only) cut-off for preparations for ingestion (i.e. fluoride supplements) to max. 0.5mg fluoride ion per dosage unit - liquid preparations for topical use in Schedule 4 unless: (i) exempt from scheduling: max. 220mg/kg, in packs containing max. 120mg total fluoride when fitted with a child-resistant closure (CRC) and labelled: (a) according to the RASML when for therapeutic use, or (b) with warning statements to the effect of "Do not swallow" and "Do not use in children 6 years of age or less" when for non therapeutic use. (ii) Schedule 2: max. 1000mg/kg, fitted with a CRC and labelled as above. (iii) Schedule 3: max. 5500mg/kg, fitted with a CRC, which will be Schedule 3 (pharmacist only). - non-liquid preparations for topical use in Schedule 4 unless: (i) exempt from scheduling: max. 1000mg/kg. (ii) exempt from scheduling: when not in a therapeutic product and containing more than 1000mg/kg and max. 1500mg/kg, when labelled according to the RASML when for therapeutic use, or with warning statements to the effect of "Do not swallow" and "Do not use in children 6 years of age or less". (iii) Schedule 3: max. 5500mg/kg. The schedule entries now read: S2: FLUORIDES for human use: (a) in preparations for ingestion containing 0.5mg or less of fluoride ion per dosage unit; or (b) in liquid preparations for topical use containing 1000mg/kg or less of fluoride ion, in a container 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 220mg/kg or less of fluoride ion, in packs containing not more than 120mg total fluoride when fitted with a child-resistant closure and compliant with the requirements of Required Advisory Statements for Medicine Labels. (ii) for non-therapeutic use when labelled with warnings to the following effect: (A) Do not swallow; and (B) Do not use [this product/name of product] in children six years of age or less, except in preparations containing 220mg/kg or less of fluoride ion, in packs containing not more than 120mg total fluoride, when fitted with a child-resistant closure and labelled with warnings to the following effect: (A) Do not swallow; and (B) Do not use [this product/name of product] in children six years of age or less, except in preparations containing 15mg/kg or less of fluoride ion or preparations for supply to registered dental professionals or by approval of an appropriate authority. S3: FLUORIDES for human topical use: (a) in liquid preparations containing 5500mg/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 5500mg/kg or less of fluoride ion except: (i) in preparations for therapeutic use containing 1500mg/kg or less of fluoride ion and, when containing more than 1000mg/kg fluoride ion, compliant with the requirements of the Required Advisory Statements for Medicine Labels; (ii) in preparations for non-therapeutic use containing 1500mg/kg or less of fluoride ion and, when containing more than 1000mg/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 six years of age or less; or (iii) in preparations for supply to registered dental professionals or by approval of an appropriate authority. S4: FLUORIDES in preparations for human use except when included in or expressly excluded from Schedule 2 or 3.
Rabeprazole A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 2010 Australia OTC Rabeprazole 10mg was switched from prescription-only to non-prescription S3 (pharmacist only) status with effect from 1 January 2010 in oral preparations containing 10mg or less of rabeprazole for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease in packs containing not more than 14 days of supply. Effective 1 February 2016, approval of a new Appendix H entry for Rabeprazole, allowing direct-to-consumer advertising. Effective 1 June 2016, S3 to S2 switch for 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 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.
Omeprazole A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 2010 Australia OTC S4 (prescription) to S3 (pharmacist only) on 1 September 2010 in oral preparations containing 20mg 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. Effective 1 February 2016, approval of Appendix H entry for Omeprazole, allowing direct-to-consumer advertising. Effective 1 June 2016, S3 to S2 switch for 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. Other entries in S3 and S4
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.
Dimeticone A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders — Australia OTC General sale. Spelt 'dimethicone' in Australia.
Aluminium hydroxide A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders — Australia OTC General sale.
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.
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".
Metoclopramide A Alimentary tract and metabolism. Alimentary tract and metabolism A03. Drugs for functional gastrointestinal disorders 2000 Australia OTC Effective March 2000, switched to S3 (pharmacist only) 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. Advertising to the general public is not permitted.
Famciclovir D Dermatologicals. Dermatologicals D06. Antibiotics and chemotherapeutics for dermatological use 2012 Australia OTC Effective 1 May 2012, Famciclovir for oral use, in divided preparations, containing a total dose of 1500mg or less of famciclovir for the treatment of herpes labialis (cold sores). All other famciclovir preparations continue to be Rx.
Dimenhydrinate (diphenhydramine and 8-chlorotheophylline) A Alimentary tract and metabolism. Alimentary tract and metabolism A04. Antiemetics and antinauseants — Australia OTC S2 (pharmacy only) in primary packs of up to 10 doses for the prevention or treatment of motion sickness, except in preparations for the treatment of children under 2 years of age (S4). S3 (pharmacist only) in oral preparations except when included in S2 (e.g. larger primary pack). S3 preparations may be advertised ONLY if indicated for the prevention and relief of motion sickness.
Hyoscine (Scopolamine) A Alimentary tract and metabolism. Alimentary tract and metabolism A04. Antiemetics and antinauseants — Australia OTC Up to 1 June 2002, preparations containing max 0.25% of hyoscine were sold as pharmacy medicines (S2). Effective 1 June 2002, only the following oral and transdermal preparations are permitted as S2. All others have been rescheduled to S4 (prescription medicines): (a) for transdermal use in preparations containing max 2mg of total solanaceous alkaloids per dosage unit, or (b) for oral use: (i) in undivided preparations containing max 0.03% of total solanaceous alkaloids when labelled with a dose of max 0.3mg of total solanaceous alkaloids and a recommended daily dose of max 1.2mg of solanaceous alkaloids, or (ii) in divided preparations containing max 0.3mg of total solanaceous alkaloids per dosage unit, when labelled with a recommended daily dose of max 1.2mg of total solanaceous alkaloids.
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.'
Bisacodyl A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives — Australia OTC General sale.
Nitro-glycerine C Cardiovascular system. Cardiovascular system C01. Cardiac therapy — Australia OTC Known in Australia as Glyceryl trinitrate. S3 (pharmacist only) in preparations for oral use and in preparations for rectal use. All other preparations are S4 (prescription). Advertising to the general public is not permitted.
Lactulose A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives — Australia OTC General sale.
Macrogol (Polyethylene glycol 3350) A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives 2000 Australia OTC Effective 1 December 2000, Macrogol 3350 available as a Pharmacist-Only (S3) medicine for oral use for bowel cleansing purposes. The entry was amended effective 1 May 2007 to refer to 'Macrogol in preparations for oral use for bowel cleansing prior to diagnostic, medical or surgical procedures'. No advertising to the general public is permitted. Macrogols when labelled for use as laxatives for the relief of constipation are available on General Sale (GSL). Effective 1 June 2014, new Schedule 2 (pharmacy only) entry for Macrogols in preparations for oral use as a liquid concentrate for laxative use. (All other macrogols, e.g. in powder form, when labelled for laxative use, remain GSL).
Picosulfate (sodium) A Alimentary tract and metabolism. Alimentary tract and metabolism A06. Laxatives — Australia OTC Effective 1 September 2002, sodium picosulfate switched from GSL to S3 (pharmacist only) in preparations for oral use for bowel cleansing prior to diagnostic medical and surgical procedures. Advertising to the general public is not permitted.
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.
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'.
Orlistat A Alimentary tract and metabolism. Alimentary tract and metabolism A08. Antiobesity preparations 2004 Australia OTC Effective 1 May 2004, S4 (prescription) to S3 (pharmacist only) switch for products containing max 120mg of orlistat per dosage unit. All other preparations remain S4. Effective 1 October 2007, Schedule H (S3 substances that may be advertised to the public) entry deleted, meaning consumer advertising no longer allowed.
Vitamin A (Retinol) A Alimentary tract and metabolism. Alimentary tract and metabolism A11. Vitamins — Australia OTC General sale in preparations for topical use containing max 1% of vitamin A, in preparations for internal use containing max 3000 micrograms retinol equivalents of vitamin A per daily dose, or in preparations for parenteral nutrition replacement.
Selenium A Alimentary tract and metabolism. Alimentary tract and metabolism A12. Mineral supplements — Australia OTC S2 (pharmacy only) in preparations for human therapeutic use, except for topical use containing max 3.5% of selenium sulfide (GSL) or in preparations for oral use with a recommended daily dose of max 150 micrograms (GSL). Rx for human oral use with a recommended daily dose of more than 300 micrograms.
Amorolfine (topical) D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use — Australia OTC March 1999, S4 (prescription) to S3 (pharmacist only) switch in topical preparations containing max 5% for the treatment of onychomycoses. March 2000, all amorolfine preparations for topical use switched from S4 to S3, except for preparations containing max 0.25%, which were switched from S4 to S2 (pharmacy only). September 2006, S2 to GSL switch for preparations for treatment of tinea pedis. September 2010, all amorolfine preparations for topical use switched from S3 to S2. S2 entry now reads "Amorolfine in preparations for topical use except in preparations for the treatment of tinea pedis."
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.
Sucralfate A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 1982 Australia OTC General sale.
Ciclopirox Olamine D Dermatologicals. Dermatologicals D01. Antifungals for dermatological use 2001 Australia OTC Effective 1 September 2001, ciclopirox included in S3 (pharmacist only) when in dermal preparations containing more than 1%, and in S2 (pharmacy only) when in preparations for dermal use containing max 1% of ciclopirox. S2: Ciclopirox in preparations for dermal use containing less than 2% of ciclopirox with effect from 1 September 2002. Indication for treatment of nails included in S2 entry from 1 January 2007. Effective 1 May 2007: GSL for preparations for the treatment of tinea pedis. Effective 1 September 2012, S2 entry amended to allow for preparations for application to the nails, containing max 8% of ciclopirox. S2 entry now reads: Ciclopirox - (a) in preparations for dermal use containing 2% or less of ciclopirox, except in preparations for the treatment of tinea pedis; or (b) in preparations for application to the nails containing 8% or less of ciclopirox. The S3 preparations cannot be advertised to the general public.
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.
Pantoprazole A Alimentary tract and metabolism. Alimentary tract and metabolism A02. Drugs for acid related disorders 2008 Australia OTC Pantoprazole was switched on 1 May 2008 from prescription-only to S3 status (pharmacist only) in oral preparations containing 20mg or less for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease, in packs containing not more than 14 days of supply. The product cannot be advertised to the general public. 2015: A new Schedule 2 (pharmacy only) entry was approved for Pantoprazole - in oral preparations containing 20mg 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 7days’ supply. Effective 1 June 2015, approval of a new Appendix H entry for pantoprazole, allowing direct-to-consumer advertising.
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.
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.
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