Label: DIO PORORO KIDS FOAMING- sodium fluoride paste, dentifrice

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

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Drug Label Information

Updated June 1, 2017

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  • ACTIVE INGREDIENT

    sodium fluoride, allantoin


  • INACTIVE INGREDIENT

    xylityl, glucosyl stevia, sodium lauroyl sarcosinate, hydroxyapatite, methylparaben, natural strawberry flavor, camellia sinensis leaf ext, water


  • PURPOSE

    for dental care



  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    spray out 1 time in mouth and gargle for 30 seconds
    spray out 1 time in mouth and use toothbrush



  • WARNINGS

    store at room temperature


  • DOSAGE & ADMINISTRATION

    for dental use only

  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DIO PORORO KIDS FOAMING 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75902-3001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 g  in 100 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75902-3001-150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/04/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/04/2014
    Labeler - Dio Corporation (631085206)
    Registrant - Dio Corporation (631085206)
    Establishment
    NameAddressID/FEIBusiness Operations
    KMPharmaceutical Co., Ltd.688679158manufacture(75902-3001)
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