Label: 75% ETHANOL DISINFECTANT (WASHING-FREE) (instant hand disinfectant- ethanol75% 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 May 29, 2020

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  • DOSAGE & ADMINISTRATION

    store in a cool, dry and ventilated place.

  • INACTIVE INGREDIENT

    WATER

  • INDICATIONS & USAGE

    1.Sanitize hands: Evenly spray or apply the disinfectant to the hand once or twice with the action time of about 1 minutes to achieve the disinfection effect. Surgical hand disinfectant wipe 2 times, with the action time of about 3 minutes to achieve the disinfection

    effect.
    2. Skin disinfection:evenl spray the disinfectant or rub it on the skin surface 2 times,with the action time of about 3 minutes to achieve the disinfection effect.
    3.surface disinfection: spray the stock solution on the surface of the object, keep it wet or wipe the surface of the object 2 times, a sound sterilization will be achieved within 5 minutes.

  • ACTIVE INGREDIENT

    ALCOHOL

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    Disinfection
    Sterilization

  • 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
    75% ETHANOL DISINFECTANT (WASHING-FREE) 
    instant hand disinfectant (ethanol75%) liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53074-002
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL187.5 mL  in 250 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeBULLETSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53074-002-01250 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(53074-002)
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