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benzoyl peroxide liquid
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----------BP 7% Wash
DOSAGE AND ADMINISTRATION
BP 7% Wash should be used once or twice daily on the affected areas, or as directed by a physician. Wet skin areas to be treated. Liberally apply, BP 7% Wash by massaging gently into skin for 10-20 seconds, working into a full lather. Rinse thoroughly and pat dry. If excessive drying occurs, rinse the cleanser off sooner or use less often.
BP 7% Wash should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product.
WARNINGS AND PRECAUTIONS
KEEP 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. Once irritation clears, treatment may often be resumed with less frequent application.
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.
Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy.
The use of tretinoin and hydroquinone topical preparations should be avoided when using this product.
USE IN SPECIFIC POPULATIONS
Pregnancy Category C – Animal reproduction studies have not been conducted with benzoyl peroxide. It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzoyl peroxide should be used by a pregnant woman only if clearly needed. There are no available data on the effect of benzoyl peroxide on the later growth, development, and functional maturation of the unborn child.
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.
BP 7% Wash is a topical preparation containing benzoyl peroxide as the active ingredient for use in the treatment of acne vulgais. Each mL of BP 7% Wash contains 70mg of benzoyl peroxide in an emulsion base consisting of: Aloe Barbedensis Leaf Extract, Carbomer, Cetyl Alcohol, Disodium Laureth Sulfosuccinate, PEG-100 Stearate, Glycerin, Camellia Oleifera Leaf (Green Tea) Extract, Octoxynol-13, Magnesium Aluminum Silicate, Propylene Glycol, Purified Water, PPG-14 Palmeth-60 Hexyl Dicarbamate, Xanthan Gum, Allantoin, Benzyl Alcohol, Glyceryl Stearate, Panthenol, Sodium Citrate, Sodium Hyaluronate, Triethanolamine.
Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic.
The exact mechanism 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 absorbed by the skin where it is metabolized to benzoic acid and excreted as benzoate in the urine. There is no evidence of systemic toxicity in humans caused by benzoyl peroxide.
Carcinogenesis, 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. Benzoyl peroxide has not been found to be mutagenic (Ames Test). There are no published data indicating impairment of fertility.
HOW SUPPLIED/STORAGE AND HANDLING
BP 7% Wash is supplied as follows:
PATIENT COUNSELING INFORMATION
EXCESSIVE USE OF TOPICAL BENZOYL PEROXIDE
Revised: 12/2010 River's Edge Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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