Label: YOUKE AN- benzalkonium chloride disinfectant spray liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 20, 2020

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  • ACTIVE INGREDIENT

    benzalkonium chloride

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Kills 99.99% of germs

  • DOSAGE & ADMINISTRATION

    a little

  • INDICATIONS & USAGE

    It shall be directly sprayed onto skin, wounds, mucosa and infected parts. It can be applied several times a day to bring continuous antiseptic effects on skin surface for lasting protection.

  • INACTIVE INGREDIENT

    Propylene glycol

    Sodium dihydrogen phosphate dihydrate

    Disodium hydrogen phosphate

    Disodium edetate, dihydrate

    water

  • WARNINGS

    1.This product is one kind of solution for external use, and is never for internal usage.
    2.Activity of this product may be affected by anion surfactant or soap, and cannot be used together.
    3.It is forbidden for people who are allergic to this product.
    4.Turbidity or deposits may appear at a low temperature. It can be placed in warm waterfor heating, or used after it is dissolved through shaking.
    5.It shall be sealed and kept in a dark and dry place.
    6.Mucosa disinfection is only used for diagnosis and treatment by a medical institution.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    YOUKE AN 
    benzalkonium chloride disinfectant spray liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54749-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM0.072 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Colorwhite (transparent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54749-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/06/2020
    Labeler - HUNAN ZONWE PHARMACEUTICAL CO., LTD. (547493962)
    Establishment
    NameAddressID/FEIBusiness Operations
    HUNAN ZONWE PHARMACEUTICAL CO., LTD.547493962manufacture(54749-001)
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