Label: HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E- 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, 2010

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62% (ANTISEPTIC)

  • USES AND DIRECTIONS

    • USES: TO HELP REDUCE BACTERIA ON THE SKIN.
    • DIRECTIONS: PUT A SMALL AMOUNT INTO YOUR PALM AND BRISKLY RUB HANDS TOGETHER UNTIL DRY.
  • WARNINGS

    • FOR EXTERNAL USE ONLY.IN CASE OF ACCIDENTAL INGESTION, SEEK MEDICAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    WHEN USING THIS PRODUCT

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

    STOP USE AND ASK A DOCTOR IF

    SKIN IRRITATION OR REDNESS DEVELOPS.

    KEEP OUT OF REACH OF CHILDREN

    FOR CHILDREN UNDER 6, USE ONLY WITH ADULT SUPERVISION. NOT RECOMMENDED FOR USE ON INFANTS.

  • OTHER INFORMATION

    FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME.

  • PACKAGE FRONT AND BACK LABELS

    • 8OZ FRONT AND BACK LABELS: HCF8OZ.jpg
      8OZ FRONT AND BACK LABELS
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  WITH MOISTURIZERS AND VITAMIN E
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62.0000 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-225-08237 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/05/2010
    Labeler - HEB (007924756)
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