{"adverse_reactions":["Although rare, sodium sulfacetamide may cause local irritation."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate carcinogenic potential."],"clinical_pharmacology":["The most widely accepted mechanism of action of sulfonamides is the woods-fields 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 halflife 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":["Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is not to be used by patients with kidney disease."],"description":["Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl)sulfonyl]-acetamide monosodium salt, monohydrate. The structural formula is: Structure"],"dosage_and_administration":["Wash affected areas once or twice daily, or as directed by your physician. Avoid contact with eyes or mucous membranes. Wet skin and leberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full leather, rinse thoroughly and pat dry. If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often. FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPTHALMIC USE. (KEEP AWAY FROM EYES). KEEP OUT OF REACH OF CHILDREN (Shake well before use)"],"effective_time":"20260123","how_supplied":["Sodium Sulfacetamide 9.8% & Sulfur 4.8 % Cleanser is available in 10 oz (285 g) bottle, NDC 87026-205-10."],"id":"4915e4eb-5308-d2db-e063-6394a90a67b3","inactive_ingredient":["Aloe Vera Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Disodium EDTA, Glycerin, Glyceryl Stearate SE, PEG-100 Stearate, Phenocyethanol, Purified Water, Sodium Laureth Sulfate, Sodium Thiosulfate, Strearyl Alcohol, Triacetin, Xanthan Gum."],"indications_and_usage":["Sodium Sulfacetamide 9.8% & Sulfur 4.8% 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 the human milk following topical use of Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser. However, small amounts of orally administered sulfonamides have milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is administered to a nursing woman."],"openfda":{"brand_name":["SODIUM SULFACETAMIDE, SULFUR"],"generic_name":["SODIUM SULFACETAMIDE 9.8% SULFUR 4.8%"],"is_original_packager":[true],"manufacturer_name":["Aspen Medical LLC"],"package_ndc":["87026-205-10"],"product_ndc":["87026-205"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["TOPICAL"],"rxcui":["1494169"],"spl_id":["4915e4eb-5308-d2db-e063-6394a90a67b3"],"spl_set_id":["4915e4eb-5307-d2db-e063-6394a90a67b3"],"substance_name":["SULFACETAMIDE SODIUM","SULFUR"],"unii":["4NRT660KJQ","70FD1KFU70"]},"package_label_principal_display_panel":["Aspen Medical NDC 87026-205-10 Rx Only Sodium Sulfacetamide & Sulfur Sodium Sulfacetamide 9.8% Sulfur 4.8% 9.8%/4.8% Cleanser For External Use only NET WT. 10 OZ. (285 g) Label"],"pediatric_use":["PEDIATRIC USE Safety and effectiveness in children under the age of 12 have not been established."],"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 & 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 Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser. It is also not known whether Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser should be given to a pregnant woman only if clearly needed. PEDIATRIC USE Safety and effectiveness in children under the age of 12 have not been established. NURSING MOTHERS It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser. However, small amounts of orally administered sulfonamides have milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser is administered to a nursing woman."],"pregnancy":["PREGNANCY Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser. It is also not known whether Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser should be given to a pregnant woman only if clearly needed."],"set_id":"4915e4eb-5307-d2db-e063-6394a90a67b3","spl_product_data_elements":["SODIUM SULFACETAMIDE, SULFUR Sodium Sulfacetamide 9.8% Sulfur 4.8% BUTYLATED HYDROXYTOLUENE TRIACETIN SULFACETAMIDE SODIUM SULFACETAMIDE EDETATE DISODIUM SULFUR SULFUR SODIUM THIOSULFATE ALOE BARBADENSIS LEAF POWDER GLYCERYL STEARATE SE PHENOXYETHANOL CETOSTEARYL ALCOHOL COCAMIDOPROPYL BETAINE WATER CITRIC ACID GLYCERIN PEG-100 STEARATE SODIUM LAURETH SULFATE XANTHAN GUM"],"spl_unclassified_section":["Rx Only FOR EXTERNAL USE ONLY. NOT FOR INTRA VAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES)","This bottle is not filled to the top but does contain 10 oz of product as identified on the front panel of the bottle.","USA Manufactured For: Aspen Medical LLC 8 The Green Ste. B Dover, DE 19901 Rev. 10/25"],"storage_and_handling":["Store at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature. Protect from freezing. In case of accidental ingestion contact a Poison Control Center immediately. Keep container tightly closed. You may report side effects by calling the FDA at 1-800-FDA-1088"],"user_safety_warnings":["CAUTION If redness or irritation occurs, discontinue use. Call your doctor for medial advice about side effect."],"version":"1","warnings":["Although it is 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."]}