Label: FOAMFRESH ANTIBACTERIAL HAND WASH - chloroxylenol liquid

  • NDC Code(s): 11429-1005-1, 11429-1005-2, 11429-1005-3, 11429-1005-4, view more
    11429-1005-5, 11429-1005-6
  • Packager: Woodbine Products Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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

  • ACTIVE INGREDIENT

    Active Ingredient

    Chloroxylenol 0.25%

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  • PURPOSE

    Purpose

    Antibacterial

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  • INDICATIONS & USAGE

    Uses:

    For hand washing to decrease bacteria on the skin.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions:

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

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  • STORAGE AND HANDLING

    Other Information:

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

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  • 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.

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  • 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

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  • INGREDIENTS AND APPEARANCE
    FOAMFRESH ANTIBACTERIAL HAND WASH  
    chloroxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11429-1005
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURYL SULFATE  
    COCAMIDOPROPYL BETAINE  
    LAURYL GLUCOSIDE  
    DMDM HYDANTOIN  
    PROPYLENE GLYCOL  
    FD&C BLUE NO. 1  
    FD&C YELLOW NO. 6  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11429-1005-1 59 mL in 1 BOTTLE, PLASTIC
    2 NDC:11429-1005-2 250 mL in 1 BOTTLE, PLASTIC
    3 NDC:11429-1005-3 1000 mL in 1 BOTTLE, PLASTIC
    4 NDC:11429-1005-4 2125 mL in 1 BOTTLE, PLASTIC
    5 NDC:11429-1005-5 3785 mL in 1 BOTTLE, PLASTIC
    6 NDC:11429-1005-6 1500 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/28/2012
    Labeler - Woodbine Products Company (004220323)
    Establishment
    Name Address ID/FEI Business Operations
    Woodbine Products Company 004220323 manufacture(11429-1005)
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