Label: FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH- chloroxylenol solution

  • NDC Code(s): 11429-1010-1, 11429-1010-3, 11429-1010-7, 11429-1010-8
  • Packager: Woodbine 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 20, 2018

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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 vigorous for 30 seconds, rinse and dry.

  • STORAGE AND HANDLING

    Other Information:

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

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Sodium Lauryl Sulfate, Lauryl Glucoside, Cocamidopropyl Betaine, Decyl Glucoside. Potassiom Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol and Fragrance

  • PRINCIPAL DISPLAY PANEL

    FOAMFresh

    DYE FREE

    ANTIBACTERIAL

    Hand WASH

    Sense the

    Difference

    Stock # 5110DF

    1250 ml (42 fl.oz.)

    container label

  • INGREDIENTS AND APPEARANCE
    FOAMFRESH DYE FREE ANTIBACTERIAL HAND WASH 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 2.5 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1010-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
    2NDC:11429-1010-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
    3NDC:11429-1010-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
    4NDC:11429-1010-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/20/2018
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1010)
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