Label: INSTANT HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 April 15, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                     Purpose

    Ethyl Alcohol 62%...................Antibacterial

  • PURPOSE

    Uses: hand sanitizer to help reduce bacteria on the skin that may cause disease.

  • WARNINGS

    Warnings
    For external use only.
    Flammable, keep away from fire or flame.

  • WHEN USING

    When using this product

    avoid contact with face, eyes and broken skin.  If eye contact occurs flush thoroughly with water and seek medical advice.

  • STOP USE

    Stop use and ask a doctor if; irritation and redness develop and persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions: wet hands thoroughly with product and rub into skin until dry.
    For children under 6, use under adult supervision.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water(aqua), Carbomer, PEG-18 Dimethicone, Triethanolamine, Tocopheryl Acetate, Aloe vera, Fragrance

  • DESCRIPTION


    Distributed by Tekweld Inc.  
    180 Central Avenue
    FARMINGDALE, NY 11735

    Made in China                                        MFG: 90807

  • PRINCIPAL DISPLAY PANEL

    INSTANT HAND SANITIZER

    Kills 99/99 % of Germs Instantly!

    2 FL OZ (60ml)

  • PRINCIPAL DISPLAY PANEL

    alcoholgel

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31190-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31190-400-6060 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/15/2010
    Labeler - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Registrant - Shanghai Kejing Cleaning Products Co., Ltd. (526877847)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Kejing Cleaning Products Co., Ltd.526877847manufacture
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