Label: ZONSEN BZK ANTISEPTIC- benzalkonium chloride swab

  • NDC Code(s): 72932-002-00
  • Packager: Wuhan Zonsen Medical Products 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 May 20, 2019

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  • Drug Facts

  • Active Ingredients

    Benzalkonium Chloride 0.133%

    Purpose

    First Aid Antiseptic

  • Use

    Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water.

  • Warnings

    • For external use only.

    Do not use

    in the eyes. If this happens, rinse thoroughly with water.

    Stop use and ask a doctor 

    if irritation and redness develop and persists for more than 72 hours.

    Keep out of reach of children.

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

  • Directions

    • Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.
  • Other information

    Store at room temperature 15°C-30°C(59°F-86°F)

  • Inactive Ingredients:

    purified water, sodium bicarbonate

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    ZONSEN BZK ANTISEPTIC 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72932-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.33 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72932-002-001 in 1 POUCH04/01/2019
    11.5 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 finalpart333A04/01/2019
    Labeler - Wuhan Zonsen Medical Products Co., Ltd. (554474517)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wuhan Zonsen Medical Products Co., Ltd.554474517manufacture(72932-002)
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