Label: ETHANOL MONOTONIC DISINFECTANT- ethanol monotonic disinfectan liquid

  • 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. dry. well ventilated place,away from light.

  • INACTIVE INGREDIENT

    Pure Water

  • INDICATIONS & USAGE

    1、Hand disinfection: Stock solution inunction disinfects, action time lasts 1-3minutes
    2、Object surface disinfection: Stock solution inunction disinfects or sake disinfection articles,action time lasts 1.5-3 minutes.

  • ACTIVE INGREDIENT

    Ethyl alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    1、This product is for external use and cannot be taken orally. Keep out of reach of children.
    2、Be flammable andl stay away from fire.
    3、Use sparingly for people with alcohol
    allergies.
    4 、Store in a cool. dry. well ventilated place.away from light.
    5、Do not dlisinfect fat-soluble surfaces.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ETHANOL MONOTONIC DISINFECTANT 
    ethanol monotonic disinfectan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54983-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54983-001-01100 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(54983-001)
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