Label: WHITENING FOAMING-TOOTHPASTE- sodium fluoride gel, dentifrice

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

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Drug Label Information

Updated October 4, 2011

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  • ACTIVE INGREDIENT

    active ingredients: sodium fluoride, allantoin
  • INACTIVE INGREDIENT

    inactive ingredients: ethanol sodium lauryl sulfact, xylitol, sodium saccharin, ginger, mugwort extract, cnidium extract, mint, methylparaben, water
  • PURPOSE

    for dental care
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children
  • INDICATIONS & USAGE

    brush teeth with your tooth brush or gargle after spraying it into your mouth
  • WARNINGS

    store at room temperature
  • DOSAGE & ADMINISTRATION

    use when needed
    dental use only
  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    WHITENING FOAMING-TOOTHPASTE 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75902-2001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.001 mL  in 1 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.0005 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    GINGER (UNII: C5529G5JPQ)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)  
    MINT (UNII: FV98Z8GITP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75902-2001-150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/04/2011
    Labeler - Dio Corporation (631085206)
    Registrant - Dio Corporation (631085206)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dio Corporation631085206manufacture
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