Label: E-2 FOOD PROCESSING FOAM HAND WASH - benzalkonium chloride liquid

  • NDC Code(s): 63039-1002-3
  • Packager: Chemco 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

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.13%

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  • PURPOSE

    Purpose

    Antimicrobial

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  • INDICATIONS & USAGE

    Uses:

    For hand washing to decrease bacteria on the skin.

    Recommended for repeated use.


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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.

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

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  • DOSAGE & ADMINISTRATION

    Directions:

    Pump a small amount of foam into palm of hand.

    Rub thoroughly over all surfaces of both hands for 15 seconds.

    Rinse with potable water.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid.

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  • PRINCIPAL DISPLAY PANEL

    Total Performance

    E-2 Food Processsing

    Foam Hand Wash

    Dist. By:

    Chemco

    Products Company

    Paramount, CA 90723

    800-266-2116 chemcoprod.com

    Made in the U.S.A.

    Stock # WB994360

    1000 ml (34 fl. oz.)

    container label

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  • INGREDIENTS AND APPEARANCE
    E-2 FOOD PROCESSING FOAM HAND WASH 
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63039-1002
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    COCO GLUCOSIDE  
    LAURTRIMONIUM CHLORIDE  
    COCAMIDOPROPYLAMINE OXIDE  
    CITRIC ACID MONOHYDRATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63039-1002-3 1000 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 03/31/2014
    Labeler - Chemco Products Company (063798714)
    Establishment
    Name Address ID/FEI Business Operations
    Woodbine Products Company 004220323 manufacture(63039-1002)
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