Label: ANTIBACTERIAL FOAM HAND WASH- chloroxylenol liquid

  • NDC Code(s): 63039-1005-3
  • Packager: Chemco Products Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 14, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Chloroxylenol 0.25%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses:

    For hand washing to decrease bacteria on the skin.

  • WARNINGS

    Warnings:

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    Children must be supervised in use of this product.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    For maximum efficiency, pump foam into dry hands, lather vigorously for 30 seconds, rinse and dry.

  • STORAGE AND HANDLING

    Other Information:

    Store at 20 to 25 C. (68 to 77 F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Decyl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol, Fragrance, and FDC Blue #1, FDC Yellow #5, FDC Yellow #6.

  • PRINCIPAL DISPLAY PANEL

    Total Performance

    Antibacterial

    Foam Hand Wash

    Dist.By:

    Chemco

    Products Company

    Paramount, CA 90723

    800-266-2116     chemcoprod.com

    Made in the U.S.A.

    Stock # WB994310

    1000 ml (34 fl. oz.)

    container label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL FOAM HAND WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63039-1005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63039-1005-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/11/2014
    Labeler - Chemco Products Company (063798714)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(63039-1005)
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