Label: DISINFECTANT ALCOHOL liquid

  • Category: HUMAN OTC DRUG LABEL

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 3, 2020

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  • DOSAGE & ADMINISTRATION

    This is flammable product and required to be far away of any fire source.

  • INACTIVE INGREDIENT

    WATER

    HYDROGEN PEROXIDE

    GLYCEROL

  • INDICATIONS & USAGE

    Apply to skin directly or with clean gauze, cotton or swab.For rubbing apply liberally and rub with hands.

  • ACTIVE INGREDIENT

    alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • WARNINGS

    For external use only.flammable, Keep away from fire or flame,produces serious gastric disturbances if taken interally

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT ALCOHOL 
    disinfectant alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55449-003
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL354.75 mL  in 473 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55449-003-01473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2020
    Labeler - Jiangsu Doer biotechnology Co., Ltd (554529820)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Doer biotechnology Co., Ltd554529820manufacture(55449-003)
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