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benzoyl peroxide liquid
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----------Benzoyl Peroxide Wash 7%
INDICATIONS AND USAGEBenzoyl Peroxide Wash 7% is indicated for use in the topical treatment of mild to moderate acne vulgaris.
DOSAGE AND ADMINISTRATIONBenzoyl Peroxide Wash 7% should be used once or twice daily on the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response. Shake well before using. Wet skin areas to be treated; apply Benzoyl Peroxide Wash 7% by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry.
CONTRAINDICATIONSBenzoyl Peroxide Wash 7% should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the products.
WARNINGS AND PRECAUTIONSKEEP OUT OF REACH OF CHILDREN. When using this product, avoid unnecessary sun exposure and use a sunscreen.
General: For external use only. Avoid contact with eyes and mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy.
Information for the Patient: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING OR DISCOLORATION. If excessive irritation develops, discontinue use and consult your physician.
ADVERSE REACTIONSAllergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The use of tretinoin and hydroquinone topical preparations should be avoided when using this product.
USE IN SPECIFIC POPULATIONS
If excessive scaling, erythema or edema occurs, the use of these preparations should be discontinued. To hasten resolution of the adverse effects, cool compresses may be used. After symptoms and signs subside, a reduced dosage schedule may be cautiously tried if the reaction is judged to be due to excessive use and not allergenicity.
Benzoyl Peroxide Wash 7% is a topical preparation containing benzoyl peroxide as the active ingredient incorporated into a series of microscopic concentric vesicules of oil and water. This system results in the release of the active ingredient into the skin over a sustained period of time. Ingredients include: Citric Acid, cocamidopropyl betaine, cocamine oxide, disodium laureth sulfosuccinate, disodium EDTA, Fragrance Lemon, Glycerin, Hydrogenated Castor Oil, Hypromellose, Magnesium Aluminum Silicate, Cetearyl Alcohol and PEG-3 Distearoylamidoethylmonium Methosulfate and Polysorbate 60, Methylparaben, PEG-150 Pentaerythrityl Tetrastearate and Aqua and PEG-6 Caprylic/Capric Glycerides, PEG-40 Hydrogenated Castor Oil, Poloxamer 182, Purified Water and Xanthan Gum.
CLINICAL PHARMACOLOGYThe 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.
NONCLINICAL TOXICOLOGYCarcinogenesis, Mutagenesis, Impairment of Fertility
Based upon all available evidence, benzoyl peroxide is not considered to be a carcinogen. However, data from a study using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of the findings is not known.
HOW SUPPLIED/STORAGE AND HANDLING
Benzoyl Peroxide Wash 7% is supplied as follows:
PATIENT COUNSELING INFORMATION
Revised: 12/2010 River's Edge Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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