Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)
PruGen, Inc.
Benzoyl Peroxide
Benzoyl Peroxide 70 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
INDICATIONS AND USAGE: PRTM Benzoyl Peroxide Wash is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS: PRTM Benzoyl Peroxide Wash is contraindicated in persons with a known hypersensitivity to any of its ingredients.
HOW SUPPLIED: PRTM Benzoyl Peroxide Wash is supplied in a 16 oz bottle, NDC 42546-145-16.
unapproved drug other
PR BENZOYL PEROXIDE WASH - BENZOYL PEROXIDE WASH LOTION PRUGEN, INC. _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._ ---------- PRTM BENZOYL PEROXIDE WASH REV.1.4 DESCRIPTION: PR Benzoyl Peroxide Wash 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 s a keratolytic. Benzoyl Peroxide (C14H10O4) is represented by the following chemical structure: O = C – O – O – C = O Each mL of PR Benzoyl Peroxide Wash contains 70 mg of Benzoyl Peroxide in an emulsion based formulation consisting of: aloe, carbomer 940, cetyl alcohol, disodium oleamido MEA-sulfosuccinate, disodium EDTA, glyceryl stearate/PEG-100 stearate, glycerin, green tea, laureth-12, magnesium aluminum silicate, propylene glycol, purified water, sodium coco-sulfate, sodium lauroamphoacetate, 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 excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by Benzoyl Peroxide in humans. INDICATIONS AND USAGE: PR Benzoyl Peroxide Wash is indicated for the topical treatment of acne vulgaris. CONTRAINDICATIONS: PR Benzoyl Peroxide Wash is contraindicated in persons with a known hypersensitivity to any of its ingredients. WARNING Baca dokumen lengkap