Label: SUREWELL SANITIZING WIPES- alcohol, glyceryl laurate, sodium levulinate, laurylpyridinium chloride, caprylhydroxamic acid 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 August 22, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL, GLYCERYL LAURATE, SODIUM LEVULINATE, LAURYLPYRIDINIUM CHLORIDE, CAPRYLHYDROXAMIC ACID

  • PURPOSE

    ANTIMICROBIAL

  • direction

    Open cover, pull needed number of sheets, reseal after each use.

  • Do not use

    Do not use: Do not apply it on skin where you have eczema, wounded, irritated.

    storage and cautions for handling
    A) Avoid storing under direct sunlight, hot and cool place.
    B) keep the sticker or stopper closed after use.
    C) Do not throw in the flush toilet it. because it may be clogged if it is thrown away in the flush toilet
    D) If wet tissue put back into the package with contaminated hands, it may be deteriorated.
    recommended to use within 1 month of opening.

  • Stop use and ask a doctor,

    If anyone of following symptoms such as red spot, swollenness and/or itching, occurs when using cosmetics, or symptoms appear by direct sunlight. stop using it and consult a doctor immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATION

    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.

  • Inactive

    Water, Methylpropanediol, Sodium coco pg-dimonium chloride phosphate, Levulinic acid

  • label

    79892-301-01

    79892-301-01

  • INGREDIENTS AND APPEARANCE
    SUREWELL SANITIZING WIPES 
    alcohol, glyceryl laurate, sodium levulinate, laurylpyridinium chloride, caprylhydroxamic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79892-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3 g  in 100 g
    GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087) GLYCERYL LAURATE6 g  in 100 g
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) (CAPRYLHYDROXAMIC ACID - UNII:UPY805K99W) CAPRYLHYDROXAMIC ACID4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LAURYLPYRIDINIUM CHLORIDE (UNII: KJM5A6A3YL) 5 g  in 100 g
    SODIUM LEVULINATE (UNII: VK44E1MQU8) 5 g  in 100 g
    COCOTRIMONIUM CHLORIDE (UNII: KB94658IHQ)  
    LEVULINIC ACID (UNII: RYX5QG61EI)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79892-301-0190 g in 1 POUCH; Type 0: Not a Combination Product08/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/22/2020
    Labeler - Ifons Corp. (078792164)
    Registrant - Ifons Corp. (078792164)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASUNG CO.,LTD688310506manufacture(79892-301)