{"adverse_reactions":["ADVERSE REACTIONS: Allergic contact dermatitis and dryness have been reported with topical Benzoyl Peroxide therapy."],"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: ZoDerm ® Redi-Pads™ 4.5% is intended for topical administration and contain benzoyl peroxide for use in the treatment of acne vulgaris. Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. Benzoyl peroxide (C14H10O4) is represented by the following chemical structure: ZoDerm ® Redi-Pads™ (Benzoyl Peroxide 4.5%) contain 4.5% solution of benzoyl peroxide on a textured pad. Each gram of medicated solution contains 45 mg benzoyl peroxide, urea (10%), purified water, edentate disodium, carbomer interpolymer A, triethanolamine and glycerin. zoderm-redi-pads-01.jpg"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: ZoDerm ® Redi-Pads™ : Apply to affected areas once or twice a day, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds avoiding eyes. Lightly rinse and pat dry."],"effective_time":"20120120","how_supplied":["HOW SUPPLIED: ZoDerm ® Redi - Pads™ (Benzoyl Peroxide 4.5%) contain 30 Foil Pouches, each with a single-use medicated pad (6 mL each), NDC 10337-752-10. Store at controlled room temperature 15°-25° C (59°-77° F). Protect from freezing. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Patent Pending Manufactured for: DOAK DERMATOLOGICS A SUBSIDIARY OF BRADLEY PHARMACEUTICALS INC. Fairfield, NJ 07004-2402 USA www.doakderm.com Manufactured by: Pegasus Laboratories, Inc. Pensacola, FL 32514 IL238-R2 Rev. 01/07"],"id":"fd879b4d-4ba0-4701-a1ea-1ba6b053792f","indications_and_usage":["INDICATION AND USAGE: ZoDerm ® Redi-Pads™ are indicated for the topical treatment of acne vulgaris."],"openfda":{},"overdosage":["OVERDOSAGE: If excessive scaling, erythema or edema occurs, the use of this preparation 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":["PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - CARTON zoderm-redi-pads-02.jpg"],"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 micethat is highly susceptible to developing cancer suggestthat benzoyl peroxide acts as a tumor promoter. Theclinical significance of these findings to humans isunknown. Benzoyl peroxide has not been found to bemutagenic (Ames Test) and there are no published dataindicating it impairs fertility. Pregnancy: Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conductedwith benzoyl peroxide. It is not known whether benzoylperoxide can cause fetal harm when administeredto a pregnant woman or can affect reproductioncapacity. Benzoyl peroxide should be used by a pregnantwoman only if clearly needed. There are no availabledata on the effect of benzoyl peroxide on the latergrowth, development and functional maturation of theunborn 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."],"set_id":"dde5e3c0-840d-4add-95ed-1c326661079f","spl_product_data_elements":["Zoderm benzoyl peroxide benzoyl peroxide benzoyl peroxide water urea EDETATE DISODIUM GLYCERIN TROLAMINE CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)"],"version":"2","warnings":["WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen."]}