Benzoyl Peroxide Emulsion

Dosage form: emulsion
Drug class:Topical acne agents

Medically reviewed by Drugs.com. Last updated on Aug 23, 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 Cleanser 4.5%, 6.5% and 8.5% is intended for topical administration and contains benzoyl peroxide 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:

Each mL of Benzoyl Peroxide Cleanser 4.5% contains 45 mg of benzoyl peroxide. Each mL of Benzoyl Peroxide Cleanser 6.5% contains 65 mg of benzoyl peroxide. Each mL of Benzoyl Peroxide Cleanser 8.5% contains 85 mg of benzoyl peroxide. Each mL of Benzoyl Peroxide Cleanser is in an emulsion-based formulation consisting of the following inactive ingredients: carbomer, cetyl alcohol, citric acid, disodium EDTA, disodium oleamido MEA-sulfosuccinate, glycerin, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium citrate, sodium lauryl sulfoacetate, sodium octoxynol-2 ethane sulfonate, urea (10%), and xanthan gum.

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 excre...