Label: WATER-FREE ANTIBACTERIAL 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 11, 2020

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  • DOSAGE & ADMINISTRATION

    Store in a cool. ary, well ventilated place. away from light.

  • INACTIVE INGREDIENT

    Carbo-mer

    Pure Water

    Ethyl alcohol

    Essence

    Gycerinum

    Corrosion remover

    Triethanolamine

  • INDICATIONS & USAGE

    Take appropriate amount of this product for the hand. no need to wash an.d simply rub until dry.

  • ACTIVE INGREDIENT

    Ethyl alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1、This product is for external use and can not be taken oraly.
    2、Be flammable and stay away from fire.
    3、Use sparingly for people with alcohol allergies.
    4、Store in a cool dry, well ventilated place. away from light.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    WATER-FREE ANTIBACTERIAL HAND SANITIZER 
    water-free antibacterial hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54983-002
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL270 mL  in 450 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLTRIETHANOLAMMONIUM METHOSULFATE (UNII: 2O049AX07H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    METHYL BENZOATE (UNII: 6618K1VJ9T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54983-002-01450 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/08/2020
    Labeler - Zhejiang Tengyu New Material Technology Co., Ltd. (549825566)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Tengyu New Material Technology Co., Ltd.549825566manufacture(54983-002)
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