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

  • NDC Code(s): 58657-472-06, 58657-472-07, 58657-472-08, 58657-472-12, view more
    58657-472-13
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 17, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    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 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 C 8H 9N 2NaO 3S·H2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate.

    The structural formula is:

    struct

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

  • INDICATIONS

    SODIUM SULFACETAMIDE 10% - SULFUR 5% CLEANSER is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

  • CONTRAINDICATIONS:

    Sodium Sulfacetamide 10% & Sulfur 5% Cleanser is contraindicated in persons with know or suspected hypersensitivity to
    sulfonamides, sulfur or any other component of this preparation. Sodium
    Sulfacetamide 10% & 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.
    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.

  • OTHER SAFETY INFORMATION

    NOTICE: Protect from freezing and excessive heat. The product may tend to
    darken slightly on storage. Slight discoloration does not impair the efficacy
    or safety of the product. Keep bottle tightly closed.


    Occasionally, a slight discoloration of fabric may occur when an excessive
    amount of the product is used and comes in contact with white fabrics.
    This discoloration, however, presents no problem, as it is readily removed
    by ordinary laundering without bleaches.

  • DOSAGE AND ADMINISTRATION

    USE: Wash affected area 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. See label booklet for Full Prescribing Information.
    FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC
    USE. (KEEP AWAY FROM EYES).
    KEEP OUT OF REACH OF CHILDREN.

  • Package Label

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  • INGREDIENTS AND APPEARANCE
    SODIUM SULFACETAMIDE AND SULFUR 
    sulfacetamide sodium, sulfur liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58657-472
    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
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    1-ETHYL CITRATE (UNII: Y7R23627P5)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TRIACETIN (UNII: XHX3C3X673)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-472-06170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2021
    2NDC:58657-472-07170.3 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2021
    3NDC:58657-472-12340 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2021
    4NDC:58657-472-13340.2 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2021
    5NDC:58657-472-08227 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/15/2021
    Labeler - Method Pharmaceuticals, LLC (060216698)