Label: EXACT-RX SODIUM SULFACETAMIDE AND SULFER 10%/5% CLEANSER- sodium sulfacetamide, sulfur lotion

  • NDC Code(s): 42808-113-06, 42808-113-12
  • 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

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

  • INDICATIONS & USAGE

    INDICATIONS: Sodium Sulfacetemide 10% and Sulfer 5% Cleanser

    is indicated for he topical control of acne vulgaris, acne rosacea and

    seborrheic dermatitis.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR USE: Wash affected area once or twice daily, or

    as directed by your physician. Avoid contat 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 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% & Sulfer 5% Cleanser is

    contraindicated in persons with know or suspected hypersensitivity to sulfonamides,

    sulfer or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfer %5%

    Cleanser is not to be used by patients with kidney disease.

    CAUTION: If redness or irritaiton occurs, discontinue use.

  • INACTIVE INGREDIENT

    IA SS

  • STORAGE AND HANDLING

    Store at 20 to 25C (68 to 77F). See USP Controlled Room Temperature. 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

    pi

  • PRINCIPAL DISPLAY PANEL

    SSS 6SSS 12

  • INGREDIENTS AND APPEARANCE
    EXACT-RX SODIUM SULFACETAMIDE AND SULFER 10%/5% CLEANSER 
    sodium sulfacetamide, sulfur lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:42808-113
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM THIOSULFATE (UNII: HX1032V43M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TRIACETIN (UNII: XHX3C3X673)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42808-113-06170 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2011
    2NDC:42808-113-12340 g 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)