Label: INSTANT HAND SANITIZER - ORIGINAL- ethyl alcohol 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 July 5, 2013

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  • ACTIVE INGREDIENT

    Active Ingredient                              Purpose

    Ethyl Alcohol 62.0%......................Antimicrobial

  • PURPOSE

    XtraCare Instant Hand Sanitizer - Original

    Kills 99.9% of Germs with Moisturizers & Vitamin E

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    USE: 

    • hand sanitizer to help reduce bacteria on the skin that may cause disease
  • WARNINGS

    Warnings:

    for external use only.

    Flammable. Keep away from heat and 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 persist for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Directions:

    • wet hands thoroughly with product
    • briskly rub hands together until dry
    • children under 6 years of age should be supervised by an adult when using.
  • INACTIVE INGREDIENT

    Inactive ingredients:

    carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water, fragrance.

  • PRINCIPAL DISPLAY PANEL

    bottle label

    package label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER - ORIGINAL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-317
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33 mL  in 53 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-317-022 in 1 PACKAGE
    1NDC:64092-317-0153 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/05/2013
    Labeler - Great Lakes Wholesale & Marketing, LLC (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(64092-317)
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