ACNECIDE Topical gel Ref.[49975] Active ingredients: Benzoyl peroxide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Product name and form

Acnecide 5% w/w Gel.

Pharmaceutical Form

Topical Gel.

White to off-white, smooth gel.

Qualitative and quantitative composition

Hydrous benzoyl peroxide equivalent to Benzoyl Peroxide 5% w/w.

Excipients with known effects: One gram of gel contains 40 mg of propylene glycol (E1520).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Benzoyl peroxide

Benzoyl peroxide is a highly lipophilic, oxidising agent with keratolytic and bacteriocidal effects. The effectiveness of benzoyl peroxide in the treatment of acne vulgaris is primarily attributable to its antibacterial activity, especially with respect to Propionibacterium acnes. Benzoyl peroxide is also believed to be effective in the treatment of acne on account of its anti-inflammatory and mild keratolytic properties.

List of Excipients

Docusate sodium
Disodium edetate
Poloxamer 182
Carbomer 940
Propylene glycol (E1520)
Acrylates copolymer or glycerol microsponge
Glycerol
Colloidal anhydrous silica
Purified water
Sodium hydroxide to adjust the pH

Pack sizes and marketing

White low density polyethylene tubes. Pack sizes 15g, 30g and 60g.

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK

Marketing authorization dates and numbers

PL 10590/0006

13th July 1992 / 28/05/2003

Drugs

Drug Countries
ACNECIDE Ireland, United Kingdom

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