Topically applied benzoyl peroxide is not generally absorbed in sufficient amounts to produce systemic effects.
Excessive application may result in severe irritation. In this event, discontinue use and wait until the skin has recovered.
Cold compresses can provide relief from irritation due to excessive application.
Accidental ingestion of topical benzoyl peroxide should be managed clinically or as recommended by the National Poisons Centre, where available.
Not applicable.
Cetyl alcohol
Stearyl alcohol and Macrogol cetostearyl ether
Simethicone emulsion
Propylene glycol alginate
Dimethyl isosorbide
Fragrance X-23304
Purified water
Adverse reactions are classified by System Organ Class. Adverse reactions that occurred either during clinical studies or that were spontaneously reported are presented below.
Frequencies were defined as follows:
Very common >1/10
Common >1/100 to <1/10
Uncommon >1/1000 to <1/100
Rare>1/10000 to <1/1000
Very rare <1/10000
Not known (cannot be estimated from the available data)
| Immune System Disorders | |
| Not known: | Allergic reactions, including application site hypersensitivity and anaphylaxis |
| Skin and subcutaneous tissue disorders | |
| Very Common: | Peeling, application site erythema |
| Common: | Dryness, pruritus and contact sensitisation reactions |
| Uncommon: | Burning sensation |
| Not known: | Application site rash |
| General Disorders and Administration Site Conditions | |
| Not known: | Application site discoloration and application site reactions such as irritation and pain |
In animal toxicity studies, benzoyl peroxide was well tolerated when applied topically.
Although high doses of benzoyl peroxide have been shown to induce DNA strand breaks, the available data from other mutagenicity studies, carcinogenicity studies and a photo co-carcinogenicity study indicate that benzoyl peroxide is not a carcinogen or a photocarcinogen.
Benzoyl peroxide (250, 500, or 1000 mg/kg/day) administered orally to male rats for 29 days and female rats for 41-51 days did not affect mating period, mating rate, conception rate, delivery rate, birth rate, pregnancy period, luteinisation number, implantation number and the rate of losing embryos and fetuses after implantation. In pups, body weight was significantly decreased in the high-dose group.
Pharmacotherapeutic group: Benzoyl peroxide
ATC Code: D10A E01
Mechanism of action
Benzoyl peroxide is a highly lipophilic, oxidising agent with keratolytic and bacteriocidal effects.
Pharmacodynamic 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. The antibacterial activity of benzoyl peroxide is due to the release of active or free-radical oxygen capable of oxidising bacterial proteins. Benzoyl peroxide is also believed to be effective in the treatment of acne on account of its anti-inflammatory and mild keratolytic properties.
Radio-labelled studies have shown that absorption of benzoyl peroxide through the skin can only occur following its conversion to benzoic acid.
Following topical application, less than 5% of the dose enters systemic circulation as benzoic acid. Benzoyl peroxide is excreted as benzoic acid in the urine.
09/03/2016
Beecham Group PLC
trading as
Stiefel
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Do not store above 25°C.
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.
PL 00079/0693
No special requirements.
29 May 1996
