Label: HAND SANITIZER- hand sanitizer gel 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 November 24, 2020

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  • Active Ingredient(s)

    Alcohol 60% V/V

  • Purpose

    /

  • Use

    Hand Sanitizer Gel Cleans hands in 20 seconds. It is specially formulated to clean and freshen hand without soap and water.

    It contains moisturizers that leave hand soft. It kills germs and bacteria. No need for water and towel.

  • Warnings

    For External Use Only. Keep out of reach of children.

  • Do not use

    /

  • WHEN USING

    /

  • STOP USE

    /

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Apply enough of the product to the palm of your hand to wet your hands completely. Rub your hands together, covering all surfaces, for up to 20 seconds or until they're dry.

    If your hands are visibly dirty, however, wash with soap and water

  • Other information

    /

  • Inactive ingredients

    Carbomer, glycerinl, Aloe extract, Remaining water

  • Package Label - Principal Display Panel

    76599-011-01 30ML76599-011-02 250ML

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76599-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76599-011-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:76599-011-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Guangzhou Meidu Cosmetics Co.,Ltd. (528170214)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Meidu Cosmetics Co.,Ltd.528170214manufacture(76599-011)
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