{"adverse_reactions":["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. Excess erythema and peeling most frequently appear during the initial phase of drug use and may normally be controlled by reducing frequency of use."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["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."],"clinical_pharmacology":["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."],"contraindications":["CONTRAINDICATIONS Brevoxyl ® -4 Gel and Brevoxyl ® -8 Gel should not be used in patients who have shown hypersensitivity to benzoyl peroxide or to any of the other ingredients in the product."],"description":["DESCRIPTION Brevoxyl ® -4 Gel and Brevoxyl ® -8 Gel are topical preparations containing benzoyl peroxide 4% and 8%, respectively, as the active ingredient in a gel vehicle containing ceteareth-20, cetyl alcohol, dimethyl isosorbide, fragrance, purified water, simethicone, stearyl alcohol. The structural formula of benzoyl peroxide is: Structural formula of benzoyl peroxide"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Therapy may be initiated with either Brevoxyl ® -4 Gel or Brevoxyl ® -8 Gel. The medication should be applied once or twice daily to the affected areas. Frequency of use should be adjusted to obtain the desired clinical response. Gentle cleansing of the affected areas prior to application of Brevoxyl ® -4 Gel or Brevoxyl ® -8 Gel may be beneficial. 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."],"effective_time":"20120323","general_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."],"how_supplied":["HOW SUPPLIED Brevoxyl ® -8 Gel is supplied in 90 g (3 / 1.5 oz) tubes NDC 54868-5352-0. Store at controlled room temperature 15º – 30ºC (59º – 86ºF). Questions? call 1-888-500-DERM (3376). Serious side effects associated with use of this product may be reported to this number. BREVOXYL, STIEFEL, and STIEFEL & Design are registered trademarks of Stiefel Laboratories, Inc. © 2009 Stiefel Laboratories, Inc. 301323 Rev. April 2009 STIEFEL ® Stiefel Laboratories, Inc. 255 Alhambra Circle Coral Gables, FL 33134-7412 USA Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146"],"id":"81189e2a-b9e9-4e5e-8486-35cb2ceaa2c9","indications_and_usage":["INDICATIONS AND USAGE Brevoxyl ® -4 Gel and Brevoxyl ® -8 Gel are indicated for use in the topical treatment of mild to moderate acne vulgaris. Brevoxyl ® -4 Gel or Brevoxyl ® -8 Gel may be used as an adjunct in acne treatment regimens including antibiotics, retinoic acid products, and sulfur/salicylic acid containing preparations."],"nursing_mothers":["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."],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel NDC 54868-5352-0 Brevoxyl ® -8 Gel (benzoyl peroxide 8%) R x only AQUEOUS BASE GEL FOR TOPICAL USE Net Wt no label available"],"pediatric_use":["Pediatric Use Safety and effectiveness in children below the age of 12 have not been established."],"precautions":["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."],"pregnancy":["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."],"set_id":"52326275-fd70-4e48-8eaf-b437638b96af","spl_product_data_elements":["BREVOXYL benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETYL ALCOHOL DIMETHYL ISOSORBIDE WATER DIMETHICONE 410 STEARYL ALCOHOL"],"spl_unclassified_section":["AQUEOUS BASE ACNE GEL FOR TOPICAL USE Rx only"],"version":"1"}