Label: BZK ANTISEPTIC SWAB- benzalkonium chloride solution

  • NDC Code(s): 73288-003-01
  • Packager: NINGBO TIANBO FIRST AID PRODUCT 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 April 28, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient: Benzalkonium Chloride 0.4%

  • PURPOSE

    Purpose: First Aide Antiseptic

  • INDICATIONS & USAGE

    Uses: For external use. Help prevent infection. Antiseptic cleasing of face, hand, and body withour soap and water.

  • WARNINGS

    Warnings:

    For external use only

  • 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. If usual redness, swelling, or other symptoms occur, consult a physician immediately.

  • DOSAGE & ADMINISTRATION

    Directions: Tear open packet, unfold towelette and use to clease desire skin area. Discard towelette appropriately after single use.

  • OTHER SAFETY INFORMATION

    Do not use in the eyes or over large area of the body.

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Sodium Bicarbonate, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BZK ANTISEPTIC SWAB 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73288-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73288-003-012 in 1 PACKAGE08/29/2019
    10.85 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/29/2019
    Labeler - NINGBO TIANBO FIRST AID PRODUCT CO., LTD. (413680615)
    Registrant - NINGBO TIANBO FIRST AID PRODUCT CO., LTD. (413680615)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lights Medical Manufacture Co., Ltd.529128649manufacture(73288-003)