Label: SODIUM SULFACETAMIDE, SULFUR- sulfacetamide sodium and sulfur liquid
- NDC Code(s): 69367-244-10
- Packager: Westminster Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated April 11, 2023
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- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Each gram of Sodium Sulfacetamide 9.8% and Sulfur 4.8% Cleanser contains 98 mg of sodium sulfacetamide and 48 mg of colloidal sulfur in a vehicle consisting of 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 C8H9N2NaO3S∙H2O with molecular weight of 254.24. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform and in ether.
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CLINICAL PHARMACOLOGY
Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive Gram-positive and Gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There is no clinical data available on the degree and rate of systemic absorption of this product when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.
The following in vitro data is available but the clinical significance is unknown. Organisms that show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces. 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
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.
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PRECAUTIONS
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes.
General
Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation.
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. If the use of this product produces signs of hypersensitivity or other untoward reactions, discontinued use of the preparation. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. Systemic toxic reactions such as granulocytosis, 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. Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas. Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed. 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
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. The use of this product also should be discontinued promptly and the physician notified if any arthritis, fever or sores in the mouth develop. Avoid contact with eyes, eyelids, lips and mucous membranes.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide. The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.
Pregnancy
Category C
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
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DOSAGE AND ADMINISTRATION
Wash affected areas once or twice daily, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing cleanser off sooner or using less frequently.
See booklet for full prescribing information.
- STORAGE
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 285 g Bottle Label
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INGREDIENTS AND APPEARANCE
SODIUM SULFACETAMIDE, SULFUR
sulfacetamide sodium and sulfur liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM 98 mg in 1 g SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 48 mg in 1 g Inactive Ingredients Ingredient Name Strength AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CETYL ALCOHOL (UNII: 936JST6JCN) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) GUAR GUM (UNII: E89I1637KE) METHYLPARABEN (UNII: A2I8C7HI9T) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM THIOSULFATE (UNII: HX1032V43M) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TRIACETIN (UNII: XHX3C3X673) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69367-244-10 285 g in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 05/05/2020 Labeler - Westminster Pharmaceuticals, LLC (079516651)
