Label: PURUS ANTIBACTERIAL WIPES- glyceryl laurate, levulinic acid, caprylhydroxamic acid, alcohol cloth

  • 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 September 2, 2020

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  • ACTIVE INGREDIENT

    glyceryl laurate, laurylpyridinium chloride, caprylhydroxamic acid, alcohol, levulinic acid

  • INACTIVE INGREDIENT

    sodium coco pg-dimonium chloride phosphate, sodiu levulinate, methyl propanediol, water

  • PURPOSE

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

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    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.

  • WARNINGS

    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 thoroughly with water.

    Stop use and ask a doctor if 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.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PURUS ANTIBACTERIAL WIPES 
    glyceryl laurate, levulinic acid, caprylhydroxamic acid, alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77504-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087) GLYCERYL LAURATE0.0448 g  in 56 g
    LEVULINIC ACID (UNII: RYX5QG61EI) (LEVULINIC ACID - UNII:RYX5QG61EI) LEVULINIC ACID0.028 g  in 56 g
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) (CAPRYLHYDROXAMIC ACID - UNII:UPY805K99W) CAPRYLHYDROXAMIC ACID0.0112 g  in 56 g
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.0112 mL  in 56 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77504-0004-156 g in 1 PACKAGE; Type 0: Not a Combination Product09/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/02/2020
    Labeler - The fab Korea Co., Ltd. (694885775)
    Registrant - The fab Korea Co., Ltd. (694885775)
    Establishment
    NameAddressID/FEIBusiness Operations
    The fab Korea Co., Ltd.694885775manufacture(77504-0004)
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