KENAF WET WIPE KIDS (ALLANTOIN) LIQUID [MEDICELL BIO CO., LTD.]

KENAF WET WIPE KIDS (ALLANTOIN) LIQUID [MEDICELL BIO CO., LTD.]
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NDC 72944-0002-1
Set ID 86106dd8-b20b-15ee-e053-2991aa0aa7b2
Category HUMAN OTC DRUG LABEL
Packager MEDICELL BIO CO., Ltd.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Allantoin 0.5%

  • INACTIVE INGREDIENT

    Water, etc

  • PURPOSE

    wet tissue

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply to skin and wipe

  • WARNINGS

    1. For external use only.

    1) Do not use over the wound and irritated skin with eczema or infections

    2) Discontinue using the product if signs of irritations and/or rashes occur and seek professional medical help

    2. Keep the cover closed tight after use

    3. Do not put the left over contents back into the container to avoid deterioration

    1) Avoid contact with eyes

    2) Keep out of reach of children

    3) Store in a cool and dry place, away from direct sun light

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    KENAF WET WIPE KIDS 
    allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72944-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72944-0002-1190 g in 1 POUCH; Type 0: Not a Combination Product04/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/09/2017
    Labeler - MEDICELL BIO CO., Ltd. (689843703)
    Registrant - MEDICELL BIO CO., Ltd. (689843703)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDICELL BIO CO., Ltd.689843703manufacture(72944-0002)

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