BREVOXYL Cream Ref.[6450] Active ingredients: Benzoyl peroxide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Beecham Group PLC trading as Stiefel, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

Brevoxyl 4% Cream.

Pharmaceutical Form

Cream.

A white to off white cream.

Qualitative and quantitative composition

Benzoyl peroxide 4% w/w as hydrous benzoyl peroxide Ph. Eur.

100 g cream contains 4 g benzoyl peroxide.

Also contains cetyl alcohol, stearyl alcohol and propylene glycol alginate.

For a 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

Cetyl alcohol
Stearyl alcohol and Macrogol cetostearyl ether
Simethicone emulsion
Propylene glycol alginate
Dimethyl isosorbide
Fragrance X-23304
Purified water

Pack sizes and marketing

Lacquered aluminium or laminated tubes with white polypropylene or polyethylene screw caps.

Pack sizes: 5g, 6g, 15g, 30g, 40g and 50g.

Not all pack sizes may be marketed.

Marketing authorization holder

Beecham Group PLC

trading as Stiefel, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

PL 00079/0693

29 May 1996

Drugs

Drug Countries
BREVOXYL Hong Kong, Ireland, Poland, South Africa

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