Label: DR.LIBEAUTE THERMAL SPRING WATER- allantoin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 30, 2021

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  • ACTIVE INGREDIENT

    allantoin

  • INACTIVE INGREDIENT

    water, glycerin, butylene glycol, etc.

  • PURPOSE

    skin protecttant, hydrate

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    clean face and pat dry.

    pour toner onto the soft side onf pad or your palm and dab over the face, neck, and chest

    (please refer to the directions on the label)

  • WARNINGS

    For external use only.

    When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation or sensitization develops.

    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
    DR.LIBEAUTE THERMAL SPRING WATER 
    allantoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74084-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74084-0011-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2021
    2NDC:74084-0011-2100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/30/2021
    Labeler - Ongoong Co Ltd (695625965)
    Registrant - Ongoong Co Ltd (695625965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ongoong Co Ltd695625965label(74084-0011) , manufacture(74084-0011)
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