Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2018 Publisher: Sponsor and distributor in New Zealand: Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand, Ph (09) 918 5100, Fax (09) 918 5101 For: Galderma Australia Pty Ltd, Suite 4, ...
Pharmacotherapeutic group: Anti-acne preparations for topical use
ATC Code: D10AE01
Benzoyl peroxide has been shown to have potent broad spectrum antimicrobial activity, particularly against Proprionibacterium acnes which is normally present in affected hair follicles. In addition benzoyl peroxide has demonstrated exfoliative and comedolytic activities both of which are beneficial in the treatment of acne. The addition of acrylates copolymer provides control of excess sebum production and glycerin is included for its humectant properties.
The percutaneous penetration of benzoyl peroxide in rat, rabbit, monkey and man is low. The majority of the penetrated benzoyl peroxide is converted into benzoic acid which after absorption into the systemic circulation is rapidly eliminated by the kidney. There is no evidence of any tissue accumulation. There is no evidence that cutaneous application of the proposed clinical doses of BENZAC AC Gel should be associated with any systemic adverse reactions in humans.
In animal studies by the cutaneous route, benzoyl peroxide is associated with a minimal to moderate skin irritation potential including erythema and oedema. Phototoxic and photoallergic reactions have been reported for benzoyl peroxide therapy.
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