Label: INSTANT HAND SANITIZER ALOE VERA- 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 3, 2013

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  • ACTIVE INGREDIENT

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

  • PURPOSE

    XtraCare Instant Hand Sanitizer Aloe Vera

    kills 99.9% of germs

    with Moisturizers & Aloe Vera

  • 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

    • for handwashing to decrease bacteria on the skin
    • recommended for repeated use
  • 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
    • supervise children under 6 years in the use of this product
  • INACTIVE INGREDIENT

    water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, titanium dioxide, aloe barbadensis leaf juice.

  • OTHER SAFETY INFORMATION

    • store at 20oC to 25oC (68o to 77oF)
    • may discolor certain fabrics
  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER ALOE VERA 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL146 mL  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64092-312-01236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/03/2013
    Labeler - Great Lakes Wholesale & Marketing, LLC (361925498)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(64092-312)
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