Label: MI DEURIUM ANTIBACTERIAL WET WIPES- glyceryl laurate liquid

  • NDC Code(s): 79542-201-01, 79542-201-02
  • Packager: SEOJEON CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 28, 2023

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  • Active ingredient

    Glyceryl laurate 10%

  • Purpose

    Antiseptic

  • Use

    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

    79542-201-01

    79542-201-01

    79542-201-02

    79542-201-02

  • INGREDIENTS AND APPEARANCE
    MI DEURIUM ANTIBACTERIAL WET WIPES 
    glyceryl laurate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79542-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087) GLYCERYL LAURATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79542-201-0140 g in 1 POUCH; Type 0: Not a Combination Product07/10/2020
    2NDC:79542-201-0280 g in 1 POUCH; Type 0: Not a Combination Product07/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/10/2020
    Labeler - SEOJEON CO., LTD (694781990)
    Registrant - SEOJEON CO., LTD (694781990)
    Establishment
    NameAddressID/FEIBusiness Operations
    SEOJEON CO., LTD694781990manufacture(79542-201)
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