{"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. Excessive 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 Benzoyl peroxide creamy wash 4% and 8% 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 Benzoyl peroxide creamy wash 4% and 8% are topical preparations containing benzoyl peroxide as the active ingredient. Benzoyl peroxide creamy wash 4% and 8% contain 4% and 8% benzoyl peroxide, respectively, in a lathering cream vehicle containing alpha olefin sulfonate, cetostearyl alcohol, glycerin, glyceryl monostearate SE, methylparaben, phosphoric acid, propylene glycol, sodium PCA, white petrolatum and purified water. The structural formula of benzoyl peroxide is: Structural Formula of Benzoyl Peroxide"],"dosage_and_administration":["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 benzoyl peroxide creamy wash 4% or 8%, 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."],"effective_time":"20140623","general_precautions":["General For external use only. Avoid contact with eyes and mucous membranes. AVOID CONTACT WITH HAIR, FABRICS OR CARPETING ASBENZOYL PEROXIDE WILL CAUSE BLEACHING."],"how_supplied":["HOW SUPPLIED Benzoyl peroxide creamy wash 4% is supplied in 170 gm (6 oz) tubes: NDC 68462-414-38 Acne wash kit includes Benzoyl peroxide creamy wash 4% 170 gm (6 oz) and Soap-free cleanser lotion 106 ml (3.6 fl oz): NDC 68462-548-38 Benzoyl peroxide creamy wash 8% is supplied in 170 gm (6 oz) tubes: NDC 68462-415-38 Acne wash kit includes Benzoyl peroxide creamy wash 8% 170 gm (6 oz) and Soap-free cleanser lotion 106 ml (3.6 fl oz): NDC 68462-549-38"],"id":"96e7ae1e-17ca-4c65-a569-6e06dde9764d","indications_and_usage":["INDICATIONS AND USAGE Benzoyl peroxide creamy wash 4% and 8% are indicated for use in the topical treatment of mild to moderate acne vulgaris. Benzoyl peroxide creamy wash 4% and 8% 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":["4% Principal Display Panel 4% Tube Label","4% Kit Principal Display Panel 4% Acne Wash Kit Label","8% Principal Display Panel 8% Tube Label","8% Kit Principal Display Panel 8% Acne Wash Kit Label"],"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 ASBENZOYL 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 Pregnancy Category C – Animal reproduction studies have not been conducted with benzoyl peroxide. It is 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 Pregnancy Category C – Animal reproduction studies have not been conducted with benzoyl peroxide. It is 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":"9015d6b6-ecd1-476e-8ba6-bdf25e37862e","spl_product_data_elements":["Benzoyl Peroxide Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETOSTEARYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN PHOSPHORIC ACID PROPYLENE GLYCOL SODIUM PYRROLIDONE CARBOXYLATE PETROLATUM WATER Benzoyl Peroxide Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETOSTEARYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN PHOSPHORIC ACID PROPYLENE GLYCOL SODIUM PYRROLIDONE CARBOXYLATE PETROLATUM WATER Benzoyl Peroxide Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETOSTEARYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN PHOSPHORIC ACID PROPYLENE GLYCOL SODIUM PYRROLIDONE CARBOXYLATE PETROLATUM WATER Benzoyl Peroxide Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CETOSTEARYL ALCOHOL GLYCERIN GLYCERYL MONOSTEARATE METHYLPARABEN PHOSPHORIC ACID PROPYLENE GLYCOL SODIUM PYRROLIDONE CARBOXYLATE PETROLATUM WATER"],"spl_unclassified_section":["ACNE WASH FOR TOPICAL USE ACNE WASH KIT FOR TOPICAL USE Rx only","Manufactured by: Glenmark Generics Ltd. Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkgenerics.com January 2010 Glenmark Logo"],"storage_and_handling":["Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]."],"version":"6"}