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Brevoxyl-4 Creamy Wash, Brevoxyl-8 Creamy Wash (Stiefel)
DESCRIPTION
Brevoxyl-4 Creamy Wash and Brevoxyl-8 Creamy Wash are topical preparations containing benzoyl peroxide as the active ingredient. Brevoxyl-4 Creamy Wash and Brevoxyl-8 Creamy Wash contain: 4% and 8% Benzoyl Peroxide, respectively, in a lathering cream vehicle containing Cetostearyl Alcohol, Cocamidopropyl Betaine, Corn Starch, Dimethyl Isosorbide, Glycerin, Glycolic Acid, Hydrogenated Castor Oil, Imidurea, Methylparaben, Mineral Oil, PEG-14M, Purified Water, Sodium Hydroxide, Sodium PCA, Sodium Potassium Lauryl Sulfate, Titanium Dioxide.
The structural formula of benzoyl peroxide is:
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
Brevoxyl-4 Creamy Wash and Brevoxyl-8 Creamy Wash are indicated for use in the topical treatment of mild to moderate acne vulgaris. Brevoxyl-4 Creamy Wash and Brevoxyl-8 Creamy Wash may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations.
CONTRAINDICATIONS
Brevoxyl-4 Creamy Wash and Brevoxyl-8 Creamy Wash 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 use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING AS BENZOYL PEROXIDE WILL CAUSE BLEACHING.
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.
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.
Nursing Mothers --It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when benzoyl peroxide is administered to a nursing woman.
Pediatric Use --Safety and effectiveness in children below the age of 12 have not been established.
ADVERSE REACTIONS
Contact sensitization reactions are associated with the use of topical benzoyl peroxide products and may be expected to occur in 10 to 25 of 1000 patients. The most frequent adverse reactions associated with benzoyl peroxide use are excessive erythema and peeling which may be expected to occur in 5 of 100 patients. Excessive erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use.
DOSAGE AND ADMINISTRATION
Shake well before using. Wash the affected areas once a day during the first week, and twice a day thereafter as tolerated. Wet skin areas to be treated; apply Brevoxyl-4 Creamy Wash or Brevoxyl-8 Creamy Wash, work to a full lather, rinse thoroughly and pat dry. 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.
HOW SUPPLIED
Brevoxyl-4 Creamy Wash is supplied in 170.1 g (6.0 oz) tubes NDC 0145-2474-06.
Brevoxyl-8 Creamy Wash is supplied in 170.1 g (6.0 oz) tubes NDC 0145-2484-06.
Store at controlled room temperature, 15°-30°C (59°-86°F).
U.S. Patent No. 6,433,024
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