Label: ADVANCE ANTIBACTERIAL WIPES- benzalkonium chloride swab

  • 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 January 26, 2021

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.1% ….………………………Antimicrobial

  • Purpose

    Antimicrobial, Hand Wipes

  • Use

    • To help reduce bacteria on the skin.
    • For use when soap and water are not available.
  • Warnings

    For external use only.

  • Do not use

    • Do not use if you are allergic to any of the ingredients.
    • Do not get into eyes. In case of contact, rinse eyes thoroughly with water.
    • Avoid contact with broken skin.
    • Do not inhale or ingest.
  • WHEN USING


    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years and over;

     Apply wipe thoroughly to hands.

     Allow to dry without wiping.

     Children under 2 years, ask a doctor before use.

  • Other information

    • Store at room temperature.
    • Keep away from direct sunlight.
    • Dispose of used wipes in trash receptacle after use.
    • Do not flush.
  • Inactive ingredients

    Water, Propylene Glycol, Phenoxyethanol, Glycerin, Sodium Benzoate, Sodium Citrate, Disodium EDTA, Polysorbate 20, Citric

    Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate.

  • Package Label - Principal Display Panel

    Advance Antibacterial Wipes

  • INGREDIENTS AND APPEARANCE
    ADVANCE ANTIBACTERIAL WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79178-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79178-300-5050 in 1 PACKAGE; Type 0: Not a Combination Product01/19/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/19/2021
    Labeler - NP Korea (689007752)
    Registrant - NP Korea (689007752)
    Establishment
    NameAddressID/FEIBusiness Operations
    NP Korea689007752label(79178-300)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daol G&C Co., Ltd.693891755manufacture(79178-300)
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