Label: SULFACETAMIDE SODIUM AND SULFUR cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42582-500-21 - Packager: Bi-Coastal Pharma International LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 18, 2022
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DESCRIPTION
Sulfacetamide sodium is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sulfacetamide sodium is N-[(4-aminophenyl) sulfonyI]-acetamide, monosodium salt, monohydrate. The structural formula is:
Each gram of sulfacetamide sodium USP 9% and sulfur USP 4.5% contains 90 mg of Sodium Sulfacetamide USP and 45 mg of Sulfur USP in a cream containing: Aloe Barbadensis (Aloe Vera) Leaf Extract, Butylated Hydroxytoluene, Camellia Oleifera (Green Tea) Leaf Extract, Cetyl Alcohol, Disodium Oleamido MEA Sulfosuccinate, Edetate Disodium, Fragrance, Glycerin, Glyceryl Monostearate, Magnesium Aluminum Silicate, Methylparaben, PEG-100 Stearate, Propylparaben, Purified Water, Sodium Cocoyl Isethionate, Sodium Methyl Cocoyl Taurate, Sodium Thiosulfate, Stearyl Alcohol, Xanthan Gum.
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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, sulfacetamide sodium 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.
- INDICATIONS
- CONTRAINDICATIONS
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WARNINGS
Although rare, sensitivity to sulfacetamide sodium 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 container tightly closed.
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PRECAUTIONS
General
lf 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 longterm therapy. The object of this therapy is to achieve desquamation without irritation, but sulfacetamide sodium 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
Longterm studies in animals have not been performed to evaluate carcinogenic potential.
Pregnancy
Category C
Animal reproduction studies have not been conducted with sulfacetamide sodium and sulfur lotion. It is also not known whether sulfacetamide sodium and sulfur wash can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sulfacetamide sodium and sulfur wash should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether sulfacetamide sodium is excreted in the human milk following topical use of sulfacetamide sodium and sulfur lotion. 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 sulfacetamide sodium and sulfur wash is administered to a nursing woman.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 454 g Bottle Carton
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INGREDIENTS AND APPEARANCE
SULFACETAMIDE SODIUM AND SULFUR
sulfacetamide sodium and sulfur creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42582-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM 90 mg in 1 g SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 45 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CETYL ALCOHOL (UNII: 936JST6JCN) DISODIUM OLEAMIDO MONOETHANOLAMINE SULFOSUCCINATE (UNII: 5M1101WGSY) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) SODIUM THIOSULFATE (UNII: HX1032V43M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42582-500-21 1 in 1 CARTON 06/01/2011 1 454 g in 1 BOTTLE; Type 6: Drug/Biologic Combination Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/01/2011 Labeler - Bi-Coastal Pharma International LLC (078397428) Registrant - Bi-Coastal Pharma International LLC (078397428)
