Label: SODIUM SULFACETAMIDE, SULFUR- sulfacetamide sodium and sulfur liquid

  • NDC Code(s): 69367-247-06, 69367-247-12
  • 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 May 27, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx Only

    FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

  • DESCRIPTION

    Each gram of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser contains 100 mg of sodium sulfacetamide and 50 mg of sulfur in a formulation containing ammonium lauryl sulfate, butylated hydroxytoluene, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, glyceryl stearate SE, guar gum, methylparaben, PEG-100 stearate, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

    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:

    Chemical Structure
  • 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 known, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.

  • INDICATIONS

    Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

  • CONTRAINDICATIONS

    Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is not to be used by patients with kidney disease.

  • WARNINGS

    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. 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. In case of accidental ingestion contact a poison control center immediately. Keep container tightly closed.

  • 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 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% and Sulfur 5% Cleanser. It is also not known whether Sodium Sulfacetamide 10% and Sulfur 5% Cleanser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Sulfacetamide 10% and Sulfur 5% Cleanser should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of Sodium Sulfacetamide 10% and Sulfur 5% Cleanser. 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 Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in children under the age of 12 have not been established.

  • ADVERSE REACTIONS

    Although rare, sodium sulfacetamide may cause local irritation.

    Call your doctor for medical advice about side effects. To report a serious adverse event, please contact Westminster Pharmaceuticals at 1-844-221-7294

  • DOSAGE AND ADMINISTRATION

    Apply Sodium Sulfacetamide 10% and Sulfur 5% Cleanser once or twice daily to affected areas, or as directed by your physician. 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 off Sodium Sulfacetamide 10% and Sulfur 5% Cleanser sooner or using less often.

  • HOW SUPPLIED

    Sodium Sulfacetamide 10% and Sulfur 5% Cleanser is available in 6 oz. (170.3 g) bottles, NDC 69367-247-06 and 12 oz. (340.2 g) bottles, NDC 69367-247-12.

    Store at 15°C to 30°C (59°F to 86°F). Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

    All prescription substitutions and/or recommendations using this product shall be made subject to state and federal statutes as applicable. NOTE: This is not an Orange Book product. No representation is made as to generic status or bioequivalency. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person's professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients and chemical formulation information provided herein.

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Westminster Pharmaceuticals, LLC
    Nashville, TN 37217

    Rev. 05/20

  • PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label

    NDC 69367-247-06
    Rx Only

    Sodium
    Sulfacetamide 10%
    and Sulfur 5%
    Cleanser

    FOR EXTERNAL USE ONLY

    6 oz (170.3 g)

    Westminster
    Pharmaceuticals

    PRINCIPAL DISPLAY PANEL - 170.3 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    SODIUM SULFACETAMIDE, SULFUR 
    sulfacetamide sodium and sulfur liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69367-247
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 g
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69367-247-06170.3 g in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    2NDC:69367-247-12340.2 g in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER05/05/2020
    Labeler - Westminster Pharmaceuticals, LLC (079516651)