{"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 TRIAZ (benzoyl peroxide) 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 classified as a keratolytic. Benzoyl peroxide (C 14 H 10 O 4 ) is represented by the following chemical structure: TRIAZ 3% and 6% Foaming Cloths contain, respectively, benzoyl peroxide 3% and 6% as the active ingredient in a cleanser-based formulation consisting of: purified water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer 1342 NF, sodium hydroxide NF, glycolic acid, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP. TRIAZ 9% Foaming Cloths contains benzoyl peroxide 9% as the active ingredient in a cleanser-based formulation consisting of: puried water USP, sodium cocoyl isethionate, sodium methyl cocoyl taurate, cetyl alcohol NF, sodium lauryl sulfoacetate and disodium laureth sulfosuccinate, carbomer copolymer type B NF, glycolic acid, sodium hydroxide NF, hydroxypropyl methylcellulose, zinc lactate, sodium PCA, glycerin USP, docusate sodium USP, sodium hyaluronate, and simethicone USP. Chemical 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":"20110303","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 SIZE NDC NUMBER TRIAZ 3% Foaming Cloths 3.2 g. Individual foil-wrapped cloths, 60 per box NDC 99207-224-60 TRIAZ 6% Foaming Cloths 3.2 g. Individual foil-wrapped cloths, 60 per box NDC 99207-225-60 TRIAZ 9% Foaming Cloths 3.2 g. Individual foil-wrapped cloths, 60 per box NDC 99207-226-60 Store at 15°–25°C (59°–77°F)."],"how_supplied_table":["
SIZE NDC NUMBER
TRIAZ 3% Foaming Cloths 3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-224-60
TRIAZ 6% Foaming Cloths 3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-225-60
TRIAZ 9% Foaming Cloths 3.2 g. Individual foil-wrapped cloths, 60 per box
NDC 99207-226-60
"],"id":"b0c66c33-cdfe-4fec-82f3-1718bbc11b50","indications_and_usage":["INDICATIONS AND USAGE TRIAZ 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."],"mechanism_of_action":["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."],"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 - 60 Cloth Carton (3%) NDC 99207-224-60 TRIAZ ® (benzoyl peroxide) 3% Foaming Cloths 60 Cloths Net wt. 3.2 g each Principal Display Panel - 60 Cloth Carton (3%)","PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (6%) NDC 99207-225-60 TRIAZ ® (benzoyl peroxide) 6% Foaming Cloths 60 Cloths Net wt. 3.2 g each Principal Display Panel - 60 Cloth Carton (6%)","PRINCIPAL DISPLAY PANEL - 60 Cloth Carton (9%) NDC 99207-226-60 TRIAZ ® (benzoyl peroxide) 9% Foaming Cloths 60 Cloths Net wt. 3.2 g each Principal Display Panel - 60 Cloth Carton (9%)"],"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 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."],"set_id":"71921545-1d14-45a2-8e35-790682fe9b1a","spl_product_data_elements":["Triaz benzoyl peroxide benzoyl peroxide benzoyl peroxide water cetyl alcohol sodium lauryl sulfoacetate disodium laureth sulfosuccinate sodium hydroxide glycolic acid hypromelloses zinc lactate sodium pyrrolidone carboxylate glycerin docusate sodium hyaluronate sodium silicon dioxide dimethicone Triaz benzoyl peroxide benzoyl peroxide benzoyl peroxide water cetyl alcohol sodium lauryl sulfoacetate disodium laureth sulfosuccinate sodium hydroxide glycolic acid hypromelloses zinc lactate sodium pyrrolidone carboxylate glycerin docusate sodium hyaluronate sodium silicon dioxide dimethicone Triaz benzoyl peroxide benzoyl peroxide benzoyl peroxide water cetyl alcohol sodium lauryl sulfoacetate disodium laureth sulfosuccinate glycolic acid sodium hydroxide hypromelloses zinc lactate sodium pyrrolidone carboxylate glycerin docusate sodium hyaluronate sodium silicon dioxide dimethicone"],"spl_unclassified_section":["Rx Only","U.S. Patent 5,648,389 and Patents Pending Manufactured for: Medicis, The Dermatology Company, Scottsdale, AZ 85256 by: Tapemark, West St. Paul, MN 55118 Made in U.S.A. Prescribing information as of July 2009 www.Triaz.com 15100077"],"storage_and_handling":["Store at 15°–25°C (59°–77°F)."],"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":"14","warnings":["WARNINGS When using this product, avoid unnecessary sun exposure and use a sunscreen. Keep out of reach of children."]}