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

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 October 23, 2023

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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

    Inactive

  • 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

  • PRINCIPAL DISPLAY PANEL

    6120

  • 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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    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)