Label: INSTANT HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 February 2, 2010

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 65% (ANTISEPTIC)

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN

  • WARNINGS

    • FOR EXTERNAL USE ONLY.
    • FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USE AND ASK A DOCTOR IF

    SKIN IRRITATION OR REDNESS DEVELOPS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • OTHER INFORMATION

    STORE AT A TEMPERATURE BELOW 1100F (430C).

  • Package Front and Back Labels

    • 2OZ Front and Back Labels: topcare2.jpg
      2OZ Labels
    • 8OZ Front and Back Labels:topcare8.jpg
      8OZ Labels
  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER  WITH MOISTURIZERS AND VITAMIN E
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65.0000 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-253-0259 mL in 1 BOTTLE, PLASTIC
    2NDC:36800-253-08236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33302/02/2010
    Labeler - Topco Associates llc (006935977)
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