Label: INSTANT HAND SANITIZER (ETHANOL 75%) (instant hand gel- ethanol 75% 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 May 29, 2020

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  • DOSAGE & ADMINISTRATION

    Keep away from light and store in a cool, dry and ventilated place.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Extract、Acrylates / C10-30 Alkyl Acrylate Crosspolymer、Tetrahydroxypropyl Ethylenediamine、Glycerol、Aqua

  • INDICATIONS & USAGE

    Apply an appropriate amount of the product evenly on the hands,faces and skin of other necessary parts of the body, gently rub and massage until it is absorbed.

  • ACTIVE INGREDIENT

    Ethanol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1. This product is a topical disinfectant and should not be taken orally.
    2. Place the product out of reach of children.
    3. Inflammable, keep away from fire source.
    4. Store the product in a cool, dark and dry place.
    5. This product is not suitable for disinfection of fat-soluble surfaces.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER (ETHANOL 75%) 
    instant hand gel (ethanol 75%) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53074-007
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    EDETOL (UNII: Q4R969U9FR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53074-007-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/29/2020
    Labeler - ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD (530743277)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG ANJI HUABU INDUSTRIAL CO., LTD530743277manufacture(53074-007)
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