Label: BZK ANTIBACTERIAL- benzalkonium chloride swab

  • NDC Code(s): 69139-400-01
  • Packager: YIWU HAODING MEDICAL CO.,LTD
  • 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 March 3, 2023

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  • Active Ingredients

    Benzalkonium Chloride  0.10%

    Purpose

    Antiseptic

  • Use

    skin clean and degerming

  • Warnings

    for external use only.

    flammable, keep away fro fire or flame

    if swallowed, get medical help or contact Poison control Center right away.

  • do not use

    • in large quantities
    • over large areas of the body
    • in eyes

    stop use and ask a doctor if conditions worsen or persist

  • Directions

    for adults and childre of 2 years and over use on hands and face to clean and refresh, allow skin to air dry.

    for childre under 2 years ask a doctor before use.

    other information:

    not intended for use of delicate or sensitive skin.

  • Inactive Ingredient

    water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BZK ANTIBACTERIAL 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69139-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69139-400-011 in 1 PACKAGE03/04/2023
    10.8 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/04/2023
    Labeler - YIWU HAODING MEDICAL CO.,LTD (421362384)
    Establishment
    NameAddressID/FEIBusiness Operations
    YIWU HAODING MEDICAL CO.,LTD421362384manufacture(69139-400)
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