Label: ZEP FS ANTIMICROBIAL FOAMING HAND CLEANER- benzalkonium chloride liquid

  • NDC Code(s): 66949-996-01, 66949-996-25
  • Packager: Zep Inc.
  • 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 12/13

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  • Active ingredient

    Benzalkonium Chloride

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  • Purpose

    Antiseptic Hand Wash

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  • Uses

    • Hand washing to decrease bacteria on the skin.
    • For use in food processing facilities.
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  • Warnings

    For external use only.

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  • DO NOT USE

    Do not use in the eyes; if in eyes, rinse promptly and thoroughly with water.

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  • STOP USE

    Stop use and ask doctor if skin irritation or redness persists for more than 72 hours.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets. Children must be supervised in use of this product.

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  • Directions

    • Wet hands with water.
    • Place hands under dispenser and apply liquid soap.
    • Massage soap into hands and writsts, emphasizing back of hands, knuckles and cuticles.
    • Rise hands thoroughly and dry.
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  • Other information

    • Store at 20 to 25°C (68 to 77°F).
    • Do not freeze.
    • Dispose in accordance with all applicable federal, state and local regulations.
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  • Inactive ingredients

    Water, Cocamidopropyl Betaine, Lauramine Oxide, PEG-6 Cocamide, DMDM Hydantoin and Iodopropynyl Butylcarbamate

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  • Questions or comments?

    Call 1-800-I-BUY-ZEP (1-800-428-9937)

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  • INGREDIENTS AND APPEARANCE
    ZEP FS ANTIMICROBIAL FOAMING HAND CLEANER 
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:66949-996
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.0013 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    COCAMIDOPROPYL BETAINE  
    LAURAMINE OXIDE  
    PEG-6 COCAMIDE  
    DMDM HYDANTOIN  
    IODOPROPYNYL BUTYLCARBAMATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66949-996-01 1000 mL in 1 BOTTLE, PLASTIC
    2 NDC:66949-996-25 2500 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 04/12/2006
    Labeler - Zep Inc. (030471374)
    Establishment
    Name Address ID/FEI Business Operations
    Zep Inc. 030471374 manufacture(66949-996)
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