Label: HAND SANITIZER 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 April 22, 2020

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  • DOSAGE & ADMINISTRATION

    Keep away from flame or high heat.

  • INACTIVE INGREDIENT

    Water(Aqua, Eau.)

    Propylene Glycol

    Carbomer

    Fragrance (Parfum)

    Tocopheryl Acetate

    DISODIUM EDTA

    Linalool

  • INDICATIONS & USAGE

    Put enough product in your palm to cover hands and rub hands together briskly until dry Children should be supervised when using Hand Sanitizer.

  • ACTIVE INGREDIENT

    alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    Keep away from flame or high heat.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41366-008
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL750 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)  
    WATER (UNII: 059QF0KO0R)  
    2-(2-(2-HYDROXYPROPOXY)PROPOXY)-1-PROPANOL (UNII: 5U049772F7)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    Product Characteristics
    Colorwhite (transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41366-008-01750 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/15/2020
    Labeler - Zhejiang Meimi Technology Co., Ltd. (413668440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Meimi Technology Co., Ltd.413668440manufacture(41366-008)
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