{"adverse_reactions":["ADVERSE REACTIONS Allergic contact dermatitis and dryness have been reported with topical benzoyl peroxide therapy."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility: Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The mechanism of action of benzoyl peroxide is not totally understood but its antibacterial activity against Propionibacterium acnes is thought to be a major mode of action. In addition, patients treated with benzoyl peroxide show a reduction in lipids and free fatty acids, and mild desquamation (drying and peeling activity) with simultaneous reduction in comedones and acne lesions. Little is known about the percutaneous penetration, metabolism, and excretion of benzoyl peroxide, although it has been shown that benzoyl peroxide absorbed by the skin is metabolized to benzoic acid and then excreted as benzoate in the urine. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans."],"contraindications":["CONTRAINDICATIONS These preparations are contraindicated in patients with a history of hypersensitivity to any of their components."],"description":["DESCRIPTION SE BPO 3%, 6%, and 9% Foaming Cloths are topical preparations containing benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classifed as a keratolytic. Benzoyl peroxide (C 14 H 10 O 4 ) is represented by the following chemical structure: SE BPO 3% Foaming Cloths contain: Carbomer 1342, Sodium Hyaluronate, Cetyl Alcohol, Simethicone, Glycerine, Hydroxypropyl Methylcellulose, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Lauryl Sulfoacetate and Disodium Laureth Sulfosuccinate, Sodium PCA, Sodium Hydroxide 10% Solution, Zinc Lactate, Citric Acid, Sodium Citrate, Purified Water, Benzoyl Peroxide 3.0%, Docusate Sodium. SE BPO 6% Foaming Cloths contain: Carbomer 1342, Sodium Hyaluronate, Cetyl Alcohol, Simethicone, Glycerine, Hydroxypropyl Methylcellulose, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Lauryl Sulfoacetate and Disodium Laureth Sulfosuccinate, Sodium PCA, Sodium Hydroxide 10% Solution, Zinc Lactate, Citric Acid, Sodium Citrate, Purified Water, Benzoyl Peroxide 6.0%, Docusate Sodium. SE BPO 9% Foaming Cloths contain: Carbomer 1342, Sodium Hyaluronate, Cetyl Alcohol, Simethicone, Glycerine, Hydroxypropyl Methylcellulose, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Lauryl Sulfoacetate and Disodium Laureth Sulfosuccinate, Sodium PCA, Sodium Hydroxide 10% Solution, Zinc Lactate, Citric Acid, Sodium Citrate, Purified Water, Benzoyl Peroxide 9.0%, Docusate Sodium. structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Wash affected areas once or twice daily, or as directed by your physician. Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10–20 seconds. Avoid eyes or mucous membranes. Rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing sooner or using less often. Throw away cloth. Do not flush."],"effective_time":"20120808","general_precautions":["General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes."],"how_supplied":["HOW SUPPLIED SE BPO 3% Foaming Cloths (NDC 13925-123-01) containing 60 x 3.2 g individually-wrapped benzoyl peroxide 3% foaming cloths with NDC 13925-123-60 SE BPO 6% Foaming Cloths (NDC 13925-115-01) containing 60 x 3.2 g individually-wrapped benzoyl peroxide 6% foaming cloths with NDC 13925-115-60 SE BPO 9% Foaming Cloths (NDC 13925-140-01) containing 60 x 3.2 g Individually-wrapped benzoyl peroxide 9% foaming cloths with NDC 13925-140-60"],"id":"f7411ef8-e67b-4c77-b4bf-f6b4d26d2bed","indications_and_usage":["INDICATIONS AND USAGE SE BPO 3%, 6%, and 9% Foaming Cloths are indicated for the topical treatment of acne vulgaris."],"information_for_patients":["Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician."],"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":{},"overdosage":["OVERDOSAGE 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."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - CARTON NDC 13925- 123 -01 SE BPO 3% Foaming Cloths (benzoyl peroxide) R x Only 60 Foaming Cloths Net. wt. 3.2 g each For External Use Only SETON PHARMACEUTICALS Carton Label PRINCIPAL DISPLAY PANEL - CARTON NDC 13925- 115 -01 SE BPO 6% Foaming Cloths (benzoyl peroxide) R x Only 60 Foaming Cloths Net. wt. 3.2 g each For External Use Only SETON PHARMACEUTICALS Carton Label PRINCIPAL DISPLAY PANEL - CARTON NDC 13925- 140 -01 SE BPO 9% Foaming Cloths (benzoyl peroxide) R x Only 60 Foaming Cloths Net. wt. 3.2 g each For External Use Only SETON PHARMACEUTICALS Carton Label","PRINCIPAL DISPLAY PANEL - CARTON NDC 13925- 115 -01 SE BPO 6% Foaming Cloths (benzoyl peroxide) R x Only 60 Foaming Cloths Net. wt. 3.2 g each For External Use Only SETON PHARMACEUTICALS Carton Label PRINCIPAL DISPLAY PANEL - CARTON NDC 13925- 140 -01 SE BPO 9% Foaming Cloths (benzoyl peroxide) R x Only 60 Foaming Cloths Net. wt. 3.2 g each For External Use Only SETON PHARMACEUTICALS Carton Label","PRINCIPAL DISPLAY PANEL - CARTON NDC 13925- 140 -01 SE BPO 9% Foaming Cloths (benzoyl peroxide) R x Only 60 Foaming Cloths Net. wt. 3.2 g each For External Use Only SETON PHARMACEUTICALS Carton Label"],"pediatric_use":["Pediatric Use: Safety and effectiveness in children have not been established."],"precautions":["PRECAUTIONS General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes. Information for Patients: Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. Contact with any colored material (including hair and fabric) may result in bleaching or discoloration. If excessive irritation develops, discontinue use and consult your physician. Carcinogenesis, Mutagenesis, Impairment of Fertility: Data from several studies employing a strain of mice that are highly susceptible to developing cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. Benzoyl peroxide has not been found to be mutagenic (Ames Test) and there are no published data indicating it impairs fertility. Pregnancy: Teratogenic Effects: 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. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child. 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 have not been established."],"pregnancy":["Pregnancy:"],"set_id":"f7411ef8-e67b-4c77-b4bf-f6b4d26d2bed","spl_product_data_elements":["SE BPO 3% Foaming Cloths Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) HYALURONATE SODIUM CETYL ALCOHOL SILICON DIOXIDE GLYCERIN HYPROMELLOSES SODIUM COCOYL ISETHIONATE SODIUM METHYL COCOYL TAURATE SODIUM LAURYL SULFOACETATE DISODIUM LAURETH SULFOSUCCINATE SODIUM PYRROLIDONE CARBOXYLATE ZINC LACTATE CITRIC ACID MONOHYDRATE SODIUM CITRATE WATER SODIUM HYDROXIDE DOCUSATE SODIUM SE BPO 6% Foaming Cloths Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) HYALURONATE SODIUM CETYL ALCOHOL SILICON DIOXIDE GLYCERIN HYPROMELLOSES SODIUM COCOYL ISETHIONATE SODIUM METHYL COCOYL TAURATE SODIUM LAURYL SULFOACETATE DISODIUM LAURETH SULFOSUCCINATE SODIUM PYRROLIDONE CARBOXYLATE ZINC LACTATE CITRIC ACID MONOHYDRATE SODIUM CITRATE WATER SODIUM HYDROXIDE DOCUSATE SODIUM SE BPO 9% Foaming Cloths Benzoyl Peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) HYALURONATE SODIUM CETYL ALCOHOL SILICON DIOXIDE GLYCERIN HYPROMELLOSES SODIUM COCOYL ISETHIONATE SODIUM METHYL COCOYL TAURATE SODIUM LAURYL SULFOACETATE DISODIUM LAURETH SULFOSUCCINATE SODIUM PYRROLIDONE CARBOXYLATE ZINC LACTATE CITRIC ACID MONOHYDRATE SODIUM CITRATE WATER SODIUM HYDROXIDE DOCUSATE SODIUM"],"spl_unclassified_section":["R x Only"],"storage_and_handling":["STORAGE Store at 15º–25ºC (59º–77ºF). Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. FOR EXTERNAL USE ONLY. Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence. Manufactured For: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 06/10 Seton Pharmaceuticals"],"teratogenic_effects":["Teratogenic Effects: 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. There are no available data on the effect of benzoyl peroxide on the later growth, development and functional maturation of the unborn child."],"version":"1","warnings":["WARNINGS When using this product, avoid unnecessary sun exposure and use a sunscreen. Keep out of reach of children."]}