Label: ZYTEC GERM BUSTER HAND SANITIZER- ethanol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 28, 2011

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  • Active Ingredient

    Ethyl Alcohol 65%

    Purpose

    Antiseptic

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeat use

    Warnings

    For external use only

    Flammable, keep away from fire or flame.

    Do not use in the 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.

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • supervise children in the use of this product

    • wet hands generously with product,  rub hands together gently until dry.

    Other Information

    • store at 20o to 25o  (68o to 77oF)
    • may discolor fabrics

    Inactive Ingredients

    Aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), isopropyl alcohol,

    aminomethyl propanol, carbomer, glycerin, isopropyl myristate, propylene glycol,

    methyl gluceth-10, polysorbate 20, fragrance, water.

  • Product Labels

    MM1
    label
  • INGREDIENTS AND APPEARANCE
    ZYTEC  GERM BUSTER HAND SANITIZER
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ETHANOL (UNII: 3K9958V90M) (ETHANOL - UNII:3K9958V90M) ETHANOL143 g  in 238 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-065-01238 g in 1 BOTTLE, PUMP
    2NDC:50021-065-0252 g in 1 BOTTLE, PLASTIC
    3NDC:50021-065-03104 g in 1 BOTTLE, PLASTIC
    4NDC:50021-065-04908 g in 1 BOTTLE, PUMP
    5NDC:50021-065-05475 g in 1 BOTTLE, PUMP
    6NDC:50021-065-06713 g in 1 BOTTLE, PUMP
    7NDC:50021-065-07908 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/28/2011
    Labeler - Empack (252047519)
    Registrant - Empack (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack252047519manufacture
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