Label: 75% ALCOHOL HAND SANITIZER- 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 21, 2020

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  • DOSAGE & ADMINISTRATION

    Store below 30 °C

  • INACTIVE INGREDIENT

    ALCOHOL

    WATER

    GLYCERIN

    CARBOMER

    TRIETHANOLAMINE

    DMDM HYDANTOIN

    TOCOPHEROL

    ALOE BARBADENSIS LEAF EXTRACT

  • INDICATIONS & USAGE

    For external use, take a proper amount and rub your hands for disinfection. The action time is 1 minute.

  • ACTIVE INGREDIENT

    ALCOHOL

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    1. Topical disinfection gel, avoid oral administration;
    2. Keep it out of reach of children;
    3. Flammable and should keep it away from fire sources.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40303-003
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Color    Score    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40303-003-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/21/2020
    Labeler - Guangzhou Beauty Cosmetics Co., Ltd. (403039604)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Beauty Cosmetics Co., Ltd.403039604manufacture(40303-003)
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