Label: FOAMFRESH ANTIBACTERIAL HAND WASH- chloroxylenol liquid

  • NDC Code(s): 11429-1005-0, 11429-1005-1, 11429-1005-2, 11429-1005-3, view more
    11429-1005-4, 11429-1005-5, 11429-1005-6, 11429-1005-7, 11429-1005-8, 11429-1005-9
  • 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 June 17, 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 Ingredient:

    Water, Sodium Lauryl Sulfate, C10-16 Alkyl Glucoside, Cocamidopropyl Betaine, Lauryl Glucoside, Potassium Hydrolyzed Collagen, DMDM Hydantoin, Propylene Glycol, Fragrance and FDC Blue #1, FDC Yellow #5, FDC Yellow #6.

  • PRINCIPAL DISPLAY PANEL

    FoamFresh

    Antibacterial Hand Wash

    The easiest way to clean

    hands. A fragranced, luxuriant foam,

    it is easily dispensed for an enjoyable

    hand wash. Sense the difference.

    Woodbine Products Company

    915 West Smith Road

    Medina, OH 44256

    www.woodbineproducts.com

    Made in USA

    Stock #4510                    1000 ml. (34 fl. oz.)

    FoamFresh Antibacterial

    Fortified with Collagen

    container label

  • INGREDIENTS AND APPEARANCE
    FOAMFRESH ANTIBACTERIAL HAND WASH 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11429-1005
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11429-1005-159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    2NDC:11429-1005-2250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    3NDC:11429-1005-31000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    4NDC:11429-1005-42125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    5NDC:11429-1005-53785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    6NDC:11429-1005-61500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    7NDC:11429-1005-7750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    8NDC:11429-1005-81250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/19/2018
    9NDC:11429-1005-91100 mL in 1 BOTTLE; Type 0: Not a Combination Product09/28/2012
    10NDC:11429-1005-01125 mL in 1 BOTTLE; Type 0: Not a Combination Product09/28/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/28/2012
    Labeler - Woodbine Products Company (004220323)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(11429-1005)
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