{"adverse_reactions":["ADVERSE REACTIONS: Allergic contact dermatitis has been reported with topical benzoyl peroxide therapy."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, and Impairment of Fertility: Data from several studies using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: The mechanism of action of benzoyl peroxide has not been determined but may be related to its antibacterial activity against Propionibacterium acnes and its ability to cause drying and peeling. Benzoyl peroxide reduces the concentration of free fatty acids in the sebum. Little is known about the percutaneous penetration, metabolism and excretion of benzoyl peroxide, although it is likely that benzoic acid is a major metabolite. There is no evidence of systemic toxicity caused by benzoyl peroxide in humans."],"contraindications":["CONTRAINDICATIONS: These products are contraindicated in patients with a history of hypersensitivity to benzoyl peroxide or to any of the other ingredients of the preparations."],"description":["DESCRIPTION: BenzaShave® 5% and BenzaShave® 10% (benzoyl peroxide 5% and 10%) are topical shaving cream preparations for use in the treatment of pseudofolliculitis ( p. barbae ; ingrown hairs, razor bumps) and acne vulgaris associated with shaving. Benzoyl peroxide is an oxidizing agent which possesses antibacterial properties and is classified as a keratolytic agent. Benzoyl peroxide (C 14 H 10 O 4 ) is represented by the following chemical structure. BenzaShave® 5% Each gram of Benzashave® (benzoyl peroxide 5%) contains: benzoyl peroxide 50mg, purified water, edetate disodium, propylparaben, methylparaben, carbomer interpolymer A, sodium coco-sulfate, sodium lauroamphoacetate, glycerin, stearic acid, myristic acid, dimethicone copolyol, mineral oil and coconut acid. BenzaShave® 10% Each gram of Benzashave® (benzoyl peroxide 10%) contains: benzoyl peroxide 100mg, purified water, edetate disodium, propylparaben, methylparaben, carbomer interpolymer A, sodium coco-sulfate, sodium lauroamphoacetate, glycerin, stearic acid, myristic acid, dimethicone copolyol, mineral oil and coconut acid. chemical structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Wet area to be shaved. Apply a small amount of Benzashave® with fingertips. Gently rub over entire area and shave."],"effective_time":"20120426","general_precautions":["General: For external use only. This preparation should not be used in or near the eyes or on mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy. After the reaction clears, treatment may often be resumed with less frequent application."],"how_supplied":["HOW SUPPLIED: Benzashave® (benzoyl peroxide 5%), 4 oz (113.4 g) tube, NDC 10337-805-41. Benzashave® (benzoyl peroxide 10%), 4 oz (113.4 g) tube, NDC 10337-806-41. KEEP OUT OF REACH OF CHILDREN. Store at Controlled Room Temperature 15°-25°C (59°-77°F) FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. For control number and expiration date, see crimp of tube. Manufacture for: DERMarts® Division DOAK DERMATOLOGICS A Subsidiary of Bradley Pharmaceuticals, Inc. 383 Route 46 West Fairfield, NJ 07004-2402 USA www.doakderm.com Manufactured by: Groupe PARIMA, Inc. Montreal, QC, H4S 1X6 CANADA IN-IL249 ISS: 08/05"],"id":"c7db8ad2-ec64-4e6c-8978-34a68564e131","indications_and_usage":["INDICATIONS AND USAGE: A medicated shaving cream containing 5% or 10% benzoyl peroxide that effectively intervenes to aid in the treatment of pseudofolliculitis ( p. barbae , ingrown hairs, razor bumps) and acne vulgaris associated with shaving. This formula primes and lifts hair follicles, promoting a clean, close shave."],"information_for_patients":["Information for Patients: Avoide contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult a physician. May bleach hair and colored fabric."],"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":["PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CONTAINER NDC 10337-805-41 Rx Only BENZASHAVE ® 5% (benzoyl peroxide 5%) Medicated Shaving Cream DOAK DERMATOLOGICS Net Wt. 4oz (113.4 g) PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CONTAINER","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CARTON NDC 10337-805-41 Rx Only BENZA SHAVE ® 5% (benzoyl peroxide 5%) Medicated Shaving Cream DOAK DERMATOLOGICS Net Wt. 4oz (113.4g) PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CARTON","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CONTAINER NDC 10337-806-41 Rx Only BENZASHAVE ® 10% (benzoyl peroxide 10%) Medicated Shaving Cream DOAK DERMATOLOGICS Net Wt. 4oz (113.4 g) PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CONTAINER","PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CARTON NDC 10337-806-41 Rx Only BENZASHAVE ® 10% (benzoyl peroxide 10%) Medicated Shaving Cream DOAK DERMATOLOGICS Net Wt. 4oz (113.4g) PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 113.4 G CARTON"],"pediatric_use":["Pediatric Use: Safety and effectiveness in pediatric patients have not been established."],"precautions":["PRECAUTIONS: General: For external use only. This preparation should not be used in or near the eyes or on mucous membranes. If severe irritation develops, discontinue use and institute appropriate therapy. After the reaction clears, treatment may often be resumed with less frequent application. Information for Patients: Avoide contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult a physician. May bleach hair and colored fabric. Carcinogenesis, Mutagenesis, and Impairment of Fertility: Data from several studies using mice known to be highly susceptible to cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is unknown. 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 data available on the effect of benzoyl peroxide on the 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 pediatric patients have not been established."],"set_id":"bfecae3c-8d59-4395-a74a-ed9bf435c2da","spl_product_data_elements":["Benzashave benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE WATER EDETATE DISODIUM PROPYLPARABEN METHYLPARABEN CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) SODIUM COCO-SULFATE SODIUM LAUROAMPHOACETATE GLYCERIN STEARIC ACID MYRISTIC ACID MINERAL OIL COCONUT ACID Benzashave benzoyl peroxide BENZOYL PEROXIDE BENZOYL PEROXIDE WATER EDETATE DISODIUM PROPYLPARABEN METHYLPARABEN CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) SODIUM COCO-SULFATE SODIUM LAUROAMPHOACETATE GLYCERIN STEARIC ACID MYRISTIC ACID DIMETHICONE MINERAL OIL COCONUT ACID"],"version":"3"}