Label: SEOJEON ANTIBACTERIAL WIPES- benzalkonium chloride liquid

  • 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 November 15, 2022

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  • Active ingredient(s)

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Use(s)

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only

  • Do not use

    ● in children less than 2 months of age

    ● on open skin wounds

  • When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    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.

  • Directions

    ● Place enough product on hands to cover all surfaces. Rub hands together until dry.

    ● Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    ● Store between 15-30C (59-86F)

    ● Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    purified water,sodium coco pg-dimonium chloride phosphate , methylpropanediol, laurylpyridinium chloride, caprylhydroxamic acid, alcohol, levulinic acid, sodium levulinate

  • Package Label

    80969-501-01 45g Label 1

    80969-501-01 45g Label 2

    80969-501-02 90g Label 1

    80969-501-02 90g Label 2

  • INGREDIENTS AND APPEARANCE
    SEOJEON ANTIBACTERIAL WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80969-501
    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
    LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80969-501-0145 g in 1 POUCH; Type 0: Not a Combination Product02/26/2021
    2NDC:80969-501-0290 g in 1 POUCH; Type 0: Not a Combination Product02/26/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/26/2021
    Labeler - STRONGHOLD TRADING LLC (117694134)
    Registrant - SEOJEON CO., LTD (694781990)
    Establishment
    NameAddressID/FEIBusiness Operations
    SEOJEON CO., LTD694781990manufacture(80969-501)
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