Label: ZYTEC GERM BUSTER HAND SANITIZER- ethanol aerosol, spray

  • Category: HUMAN OTC DRUG LABEL

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 January 31, 2011

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  • Active Ingredients

    Ethyl Alcohol 80%

    Purpose

    Antiseptic

    Uses

    • For handwashing to decrease bacteria on the skin
    • recommended for repeated use

    Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Contents under pressure

    Do not puncture of incinerate

    Do not expose to heat or store at temperatures above 120oF / 50oC or in enclosed places that could overheat.

    Do not use in or near eyes.  In case of contact rinse eyes thoroughly with water.

    Stop use and ask a doctor if, irritation and redness develop and 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.

    Directions

    • spray in palm of hand ans rub over entire surface of hands
    • briskly rub hands together until dry
    • supervise children in the use of this product

    • spray product generously over hands, rub together until product drys.

    Other Information

    • may discolor certain fabric

    Inactive Ingredients

    Water (aqua) , Isobutene, Fragrance,

  • PRINCIPAL DISPLAY PANEL

    MM2
    product label
  • INGREDIENTS AND APPEARANCE
    ZYTEC  GERM BUSTER HAND SANITIZER
    ethanol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETHANOL (UNII: 3K9958V90M) (ETHANOL - UNII:3K9958V90M) ETHANOL224 g  in 400 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-080-0835 g in 1 CAN
    2NDC:50021-080-09400 g in 1 CAN
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/31/2011
    Labeler - Empack (252047519)
    Registrant - Empack (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack252047519manufacture
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