{"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: Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is contraindicated in persons with know or suspected hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is not to be used by patients with kidney disease."],"description":["DESCRIPTION Each gram of sodium sulfacetamide 10% and sulfur 5% cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a cleanser containing Aloe Vera leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenoxyethanol, Purified Water, Sodium laureth sulfate, Sodium Thiosulfate, Stearyl alcohol, Triacetin, Xanthan Gum. Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C 8 H 9 N 2 NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION USE: 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 cleanser off sooner or using less often. See label booklet for Full Prescribing Information. FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN."],"effective_time":"20260601","how_supplied":["HOW SUPPLIED Sodium Sulfacetamide 10% & Sulfur 5% Cleanser NDC 63629-9259-1: 170 g in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504"],"id":"404f3bc8-e28d-4045-bb52-05edd784e2f7","indications_and_usage":["INDICATIONS SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis."],"openfda":{"brand_name":["Sodium Sulfacetamide and Sulfur"],"generic_name":["SULFACETAMIDE SODIUM, SULFUR"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["58657-472"],"package_ndc":["63629-9259-1"],"product_ndc":["63629-9259"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"rxcui":["999613"],"spl_id":["404f3bc8-e28d-4045-bb52-05edd784e2f7"],"spl_set_id":["aaa87a7b-1ff7-43df-b82b-66dee775d851"],"substance_name":["SULFACETAMIDE SODIUM","SULFUR"],"unii":["4NRT660KJQ","70FD1KFU70"]},"other_safety_information":["NOTICE: Protect from freezing and excessive heat. The product may tend to darken slightly on storage. Slight discoloration does not impair the efficacy or safety of the product. Keep bottle tightly closed. Occasionally, a slight discoloration of fabric may occur when an excessive amount of the product is used and comes in contact with white fabrics. This discoloration, however, presents no problem, as it is readily removed by ordinary laundering without bleaches."],"package_label_principal_display_panel":["Sodium Sulfacetamide 10% & Sulfur 5% Cleanser Extended Label label extended label"],"recent_major_changes":[""],"set_id":"aaa87a7b-1ff7-43df-b82b-66dee775d851","spl_product_data_elements":["Sodium Sulfacetamide and Sulfur SULFACETAMIDE SODIUM, SULFUR BUTYLATED HYDROXYTOLUENE ALOE VERA LEAF 1-ETHYL CITRATE CETYL ALCOHOL EDETATE DISODIUM GLYCERYL STEARATE SE PEG-100 STEARATE COCAMIDOPROPYL BETAINE TRIACETIN WATER SODIUM THIOSULFATE SODIUM LAURYL SULFATE STEARYL ALCOHOL XANTHAN GUM GLYCERIN PHENOXYETHANOL SULFACETAMIDE SODIUM SULFACETAMIDE SULFUR SULFUR structure"],"spl_unclassified_section":["Rx Only"],"version":"104","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. Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF REACH OF CHILDREN."]}