{"adverse_reactions":["ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237."],"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% and Sulfur 5% Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur, or any other component of this preparation. This drug is not to be used by patients with kidney disease."],"description":["Rx Only DESCRIPTION: Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Lotion contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a lotion of benzyl alcohol, capric/caprylic triglyceride, cetyl alcohol, dimethicone, disodium EDTA, glycerin, glyceryl stearate and PEG 100 stearate, phenoxyethanol (and) methylparaben (and) butylparaben (and) ethylparaben (and) propylparaben, polyacrylamine (and) C13-14 isoparaffin (and) laureth-7, sodium thiosulfate, water, and zinc oxide. 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 3 S·H 2 O with molecular weight of 254.24. Chemically, sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is: structure"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Cleanse affected areas. Apply a thin layer to the affected areas with light massaging, 1 to 3 times daily, or as directed by a physician."],"effective_time":"20161202","how_supplied":["HOW SUPPLIED: Sodium Sulfacetamide 10% and Sulfur 5% Lotion is available in the following sizes: 30 g bottles, NDC 42792-107-01 60 g bottles, NDC 42792-107-02 Store between 15°C and 30°C (between 59°F and 86°F). Keep bottle tightly closed. KEEP OUT OF REACH OF CHILDREN. Manufactured for: Austin Pharmaceuticals, LLC 501 Silverside Road, PMB# 16 Wilmington, DE 19809 vA1 Rev. 04/2012"],"id":"42b101f5-49d4-58ce-e054-00144ff88e88","indications_and_usage":["INDICATIONS: Sodium Sulfacetamide 10% and Sulfur 5% Lotion is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis."],"openfda":{},"package_label_principal_display_panel":["label1 label2"],"set_id":"fe60005f-7ea9-4848-a89c-3d8b4641787d","spl_product_data_elements":["SODIUM SULFACETAMIDE, SULFUR SODIUM SULFACETAMIDE, SULFUR BENZYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL DIMETHICONE EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE PEG-100 STEARATE PHENOXYETHANOL METHYLPARABEN BUTYLPARABEN ETHYLPARABEN PROPYLPARABEN POLYACRYLAMIDE (1500 MW) C13-14 ISOPARAFFIN LAURETH-7 SODIUM THIOSULFATE WATER ZINC OXIDE SULFACETAMIDE SODIUM SULFACETAMIDE SULFUR SULFUR"],"version":"3","warnings_and_cautions":["WARNINGS AND PRECAUTIONS: FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this product 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. 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 epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential. Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product 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 this product. However, small amounts of orally administered sulfonamides have been reported to be excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established."]}