Label: SODIUM SULFACETAMIDE 10 % AND SULFUR 5 % CLEANSER- sodium sulfacetamide and sulfur liquid
- NDC Code(s): 83720-537-06, 83720-537-12
- Packager: Oncor Pharmaceuticals
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 10, 2024
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- SPL UNCLASSIFIED SECTION
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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:
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 ammonium 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.
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CLINICAL PHARMACOLOGY
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 half-life has variously been reported as 7 to 12.8 1 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.
- INDICATIONS & USAGE
- CONTRAINDICATIONS
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WARNINGS
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.
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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.
CARSINOGENESIS, 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 Sodium Sulfacetamide 10% & Sulfur 5% Cleanser. It is also not known whether Sodium Sulfacetamide 10% & Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% & Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.
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NURSING MOTHERS
NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted inthe human milk following topical use of Sodium Sulfacetamide 10% & Sulfur 5% 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 10% & Sulfur 5% Cleanser isadministered to a nursing woman.
- PEDIATRIC USE
- ADVERSE REACTIONS
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DOSAGE & ADMINISTRATION
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 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.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label
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INGREDIENTS AND APPEARANCE
SODIUM SULFACETAMIDE 10 % AND SULFUR 5 % CLEANSER
sodium sulfacetamide and sulfur liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83720-537 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM 100 mg in 1 g SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 50 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM LAURETH SULFATE (UNII: BPV390UAP0) SODIUM THIOSULFATE (UNII: HX1032V43M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TRIACETIN (UNII: XHX3C3X673) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83720-537-06 170 g in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2024 2 NDC:83720-537-12 340 g in 1 BOTTLE; Type 0: Not a Combination Product 05/10/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/10/2024 Labeler - Oncor Pharmaceuticals (119032580) Registrant - Oncor Pharmaceuticals (119032580)
