Benzoyl Peroxide Lotion

Dosage form: lotion
Drug class:Topical acne agents

Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.

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.

DESCRIPTION:

4% and 8% Benzoyl Peroxide Cleansing Lotions are a topical preparation containing benzoyl peroxide as the active ingredient. 4% and 8% Benzoyl Peroxide Cleansing Lotions contain benzoyl peroxide 4% and 8%, respectively, in a lathering vehicle.

Active Ingredient: Benzoyl peroxide 4% (containing dibenzoyl peroxide, water, and modifiers).
Inactive Ingredients: Benzyl Alcohol NF, Cetyl Alcohol, Citric Acid Anhydrous USP, Polyacrylamide/C13-14 Isoparaffin/ Laureth-7, Purified Water, Sodium Lauryl Sulfate, and Sodium Lauryl Sulfoacetate.

Active Ingredient: Benzoyl peroxide 8% (containing dibenzoyl peroxide, water, and modifiers).
Inactive Ingredients: Benzyl Alcohol NF, Cetyl Alcohol, Citric Acid Anhydrous USP, Polyacrylamide/C13-14 Isoparaffin/Laureth-7, Purified Water, Sodium Lauryl Sulfate, and Sodium Lauryl Sulfoacetate.

CLINICAL PHARMACOLOGY:

The exact method of action of benzoyl peroxide in acne vulgaris is not known. Benzoyl peroxide is an antibacterial agent with demonstrated activity against Propionibacterium acnes. This action, combined with the mild keratolytic effect of benzoyl peroxide is believed to be responsible for its usefulness in acne. Benzoyl peroxide is absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine.

INDICATIONS AND USAGE:

4% and 8% Benzoyl Peroxide Cleansing Lotions are indicated for use in the topical treatment of mild to moderate acne vulgaris. 4% and 8% Benzoyl Peroxide Cleansing Lotions may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.

CONTRAINDICATIONS:

4% and 8% Benzoyl Peroxide Cleansing Lotions should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.

PRECAUTIONS:

General: For external u...