{"adverse_reactions":["ADVERSE REACTIONS Although rare, sodium sulfacetamide may cause local irritation."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids."],"contraindications":["CONTRAINDICATIONS Sulfatol™ Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sulfatol™ Cleanser is not to be used by patients with kidney disease."],"description":["DESCRIPTION Sodium Sulfacetamide is a sulfonamide with antibacterial activity. Sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: Each mL of Sulfatol™ Cleanser (Sodium Sulfacetamide 10%, and Sulfur 5% in a Urea vehicle) contains 100 mg of Sodium Sulfacetamide and 50 mg of Sulfur in an emulsion base containing Urea 10%, BHT, Cetyl Alcohol, Disodium EDTA, Fragrance, Disodium Oleamido MEA Sulfosuccinate, Glyceryl and PEG-100 Stearate, Magnesium Aluminum Silicate, Methylparaben, Propylparaben, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Purified Water, Xanthan Gum. Chemical Structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Sulfatol™ Cleanser Wash affected area once or twice daily or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds, working into a full lather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing off cleanser sooner or using less often."],"effective_time":"20101130","general_precautions":["General If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris but patients should be cautioned about the possibility."],"how_supplied":["HOW SUPPLIED Sulfatol™ Cleanser is available in a 355 mL bottle. NDC 51991-173-26 Storage Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing."],"id":"f52b06f4-2d18-45d9-a383-03e28f5c5159","indications_and_usage":["INDICATIONS Sulfatol™ Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis."],"information_for_patients":["Information for Patients Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs rinse with water. If excessive irritation develops, discontinue use and consult your physician."],"nursing_mothers":["Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of Sulfatol™ Cleanser . However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfatol™ Cleanser is administered to a nursing woman."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 355 mL Bottle Carton Breckenridge Pharmaceutical, Inc. NDC 51991-173-26 Sulfatol™ Cleanser Sodium Sulfacetamide 10%, Sulfur 5% in a Urea vehicle Skin Cleanser For The Topical Treatment Of Acne Vulgaris Acne Rosacea Seborrheic Dermatitis Rx ONLY Net Wt. 355 mL PRINCIPAL DISPLAY PANEL - 355 mL Bottle Carton"],"pediatric_use":["Pediatric Use Safety and effectiveness in children under the age of 12 have not been established."],"precautions":["PRECAUTIONS General If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris but patients should be cautioned about the possibility. Information for Patients Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs rinse with water. If excessive irritation develops, discontinue use and consult your physician. Carcinogenesis, Mutagenesis, and Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential. Pregnancy Category C Animal reproduction studies have not been conducted with Sulfatol™ Cleanser . It also is not known whether Sulfatol™ Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol™ Cleanser should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether sodium sulfacetamide is excreted in human milk following topical use of Sulfatol™ Cleanser . However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sulfatol™ Cleanser is administered to a nursing woman. Pediatric Use Safety and effectiveness in children under the age of 12 have not been established."],"pregnancy":["Pregnancy Category C Animal reproduction studies have not been conducted with Sulfatol™ Cleanser . It also is not known whether Sulfatol™ Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol™ Cleanser should be given to a pregnant woman only if clearly needed."],"set_id":"0add5b14-5ab5-42a1-a4f3-f66e6f566060","spl_product_data_elements":["Sulfatol Cleanser Sulfacetamide Sodium and Sulfur Sulfacetamide Sodium Sulfacetamide Sulfur Sulfur Butylated Hydroxytoluene Cetyl Alcohol Edetate Disodium Glyceryl Monostearate Disodium Oleamido MEA-Sulfosuccinate Polyoxyl 100 Stearate Magnesium Aluminum Silicate Methylparaben Propylparaben Sodium Cocoyl Isethionate Sodium Thiosulfate Stearyl Alcohol Urea Water Xanthan Gum light-yellow"],"spl_unclassified_section":["Rx Only","Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487 Manufactured by: Groupe Parima Inc., Montréal, QC Canada H4S 1X6 06/07"],"storage_and_handling":["Storage Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP Controlled Room Temperature. Protect from freezing."],"teratogenic_effects":["Category C Animal reproduction studies have not been conducted with Sulfatol™ Cleanser . It also is not known whether Sulfatol™ Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfatol™ Cleanser should be given to a pregnant woman only if clearly needed."],"version":"2","warnings":["WARNINGS Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved. FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep bottle tightly closed."]}