Benzoyl Peroxide Soap

Generic name: benzoyl peroxide
Dosage form: soap
Drug class:Topical acne agents

Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Rx Only

DESCRIPTION:
Benzoyl Peroxide Topical Cleanser 6% is a topical, gel-based, benzoyl peroxide containing preparation for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure:

Benzoyl Peroxide Topical Cleanser 6% contains Benzoyl Peroxide USP 6% as the active ingredient, in a vehicle consisting of: carbomer interpolymer type A NF, cetyl alcohol NF, disodium oleamido MEA-sulfosuccinate, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water, sodium coco-sulfate, sodium lauroamphoacetate, xanthan gum NF.

CLINICAL PHARMACOLOGY:
The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans.

INDICATIONS AND USAGE:
Benzoyl Peroxide Topical Cleanser 6% is indicated for the topical treatment of acne vulgaris.

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