Label: BZK ANTISEPTIC TOWELETTE- 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 December 27, 2017

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  • Drug Facts


  • Active ingredient

    Benzalkonium Chloride, 0.13% w/v

  • Purpose

    First Aid Antiseptic

  • Use

    First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only.

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor.

    Consult a doctor

    in case of deep or puncture wounds, animal bites, or serious burns.

    Stop use and consult a doctor

    if the condition persists or gets worse.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the affected area
    • Apply a small amount of this product on the area 1 to 3 times daily
    • May be covered with a sterile bandage when dry
  • Inactive ingredients

    purified water, sodium bicarbonate

  • SPL UNCLASSIFIED SECTION

    Shanghai Yinjing Medical Supplies Co., Ltd.
    586 Yuanxi RD.Nanhui Industry Park,Shanghai 201300
    Tel:+86-21-6801-6511  Http://www.yinjing.cn
    E-mail: zhl@yinjing.cn
    Made in China
    LOT

  • PRINCIPAL DISPLAY PANEL

    NDC：44019-323-01

    inin      1 pad/pouch

    BZK ANTISEPTIC TOWELETTE

    For External Use Only

  • Product Label

    BZK antiseptic towelette

  • INGREDIENTS AND APPEARANCE
    BZK ANTISEPTIC TOWELETTE  
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-323
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44019-323-011 in 1 POUCH08/03/2016
    11.5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2016
    Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
    Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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