Label: EXACT-RX SODIUM SULFACETAMIDE WASH 10%- sodium sulfacetamide liquid

  • NDC Code(s): 42808-103-06, 42808-103-12
  • Packager: Exact-Rx, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 8, 2021

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  • INDICATIONS & USAGE

    INDICATIONS: Sodium Sulfacetemide 10% Wash is intended

    for topical application in the following scaling dermatoses:

    seborrheic dermatisis 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 know 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 25C (77F); excursions permitted to 15 to 30C (59 to

    86F). See USP Controlled Room. Protect from freezing.

    See bottle for lot number and expiration date

  • DESCRIPTION

    Manufactured in the U.S.A. for

    Exact-Rx, Inc., Melville, NY 11747

  • PATIENT PACKAGE INSERT

    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: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.

    HOW SUPPLIED: Sodium Sulfacetamide Wash 10% is available in a 6 fl oz (170 mL) bottle, NDC 42808-101-06, and in a 12 fl oz
    (354.8 mL) bottle, NDC 42808-101-12.

    Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

    00-101-205-00
    Iss:12/16

  • PRINCIPAL DISPLAY PANEL

    103-06

  • PRINCIPAL DISPLAY PANEL

    103-12

  • INGREDIENTS AND APPEARANCE
    EXACT-RX SODIUM SULFACETAMIDE WASH 10% 
    sodium sulfacetamide liquid
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42808-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5) SULFACETAMIDE SODIUM100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GUAR GUM (UNII: E89I1637KE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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:42808-103-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
    2NDC:42808-103-12354.8 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/01/2011
    Labeler - Exact-Rx, Inc. (137953498)