Label: SODIUM SULFACETAMIDE WASH 10%- sodium sulfacetamide liquid

  • NDC Code(s): 82429-127-08
  • Packager: Gabar Health Sciences Corp.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 January 29, 2024

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

View All Sections
  • INDICATIONS & USAGE

    INDICATIONS: Sodium Sulfacetamide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE: Wash affected areas twice daily(morning and evening) or as directed by your physician. Rinse thoroughly and pat dry. See package insert for complete product information.

  • WARNINGS

    FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES).

  • WARNINGS

    KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

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

  • CONTRAINDICATIONS

    CONTRAINDICATIONS:Sodium Sulfacetamide 10% Wash is contraindicated in persons with known or suspected hypersensitivity to sulfonamides.

  • INACTIVE INGREDIENT

    Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: citric acid, cocamidopropyl betaine, disodium EDTA, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate, sodium thiosulfate and xanthan gum.

  • STORAGE AND HANDLING

    Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room. Protect from freezing.

    See bottle for lot number and expiration date.

  • SPL UNCLASSIFIED SECTION

    Manufactured for and distributed by:
    Gabar Health Sciences Corp
    Atlanta, GA 30354

  • Adverse Reaction

    Although rare, sodium sulfacetamide may cause local irritation.

    Call your doctor for medical advice about side effects.

    To report a serious adverse event or obtain product information, call 1-470-737-9424.

  • PRINCIPAL DISPLAY PANEL

    SODIUM SULFACETAMIDE 10% WASH

    (sodium sulfacetamide 10%)

    Rx Only

    FOR EXTERNAL USE ONLY.

    NOT FOR OPHTHALMIC USE.

    Description: Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: citric acid, cocamidopropyl betaine, disodium EDTA, glyceryl stearate, methylparaben, PEG-6 caprylic/capric glycerides, PEG-60 almond glycerides, PEG-150 pentaerythrityl tetrastearate, polysorbate 60, purified water, sodium lauryl sulfate, sodium thiosulfate and xanthan gum.

    HOW SUPPLIED: Sodium Sulfacetamide Wash 10% is available in a 8 fl oz (227g) bottle, NDC 82429-127-08.

    Manufactured for and distributed by Gabar Health Sciences Corp.

    Atlanta, GA 30354

    Rev 4/23

    label

  • INGREDIENTS AND APPEARANCE
    SODIUM SULFACETAMIDE WASH 10% 
    sodium sulfacetamide liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:82429-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CAPRYLOCAPROYL POLYOXYLGLYCERIDES 6 (UNII: GO50W2HWO8)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82429-127-08227 g in 1 BOTTLE; Type 0: Not a Combination Product10/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/20/2023
    Labeler - Gabar Health Sciences Corp. (118401847)
    Registrant - Gabar Health Sciences Corp. (118401847)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!