ZYTEC GERM BUSTER HAND SANITIZER (ETHANOL) AEROSOL, SPRAY [EMPACK]

ZYTEC GERM BUSTER HAND SANITIZER (ETHANOL) AEROSOL, SPRAY [EMPACK]
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NDC 50021-080-08, 50021-080-09
Set ID 283cdcc1-0c4c-11e0-81e0-0800200c9a66
Category HUMAN OTC DRUG LABEL
Packager Empack
Generic Name
Product Class
Product Number
Application Number PART356
  • 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,

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  • PRINCIPAL DISPLAY PANEL

    MM2
    product label
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  • INGREDIENTS AND APPEARANCE
    ZYTEC  GERM BUSTER HAND SANITIZER
    ethanol aerosol, spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:50021-080
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ETHANOL (UNII: 3K9958V90M) (ETHANOL - UNII:3K9958V90M) ETHANOL 224 g  in 400 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50021-080-08 35 g in 1 CAN
    2 NDC:50021-080-09 400 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/31/2011
    Labeler - Empack (252047519)
    Registrant - Empack (252047519)
    Establishment
    Name Address ID/FEI Business Operations
    Empack 252047519 manufacture
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