Label: IONITE APF FOAM- sodium fluoride aerosol, foam

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

Drug Label Information

Updated 04/13

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  • INACTIVE INGREDIENT

    Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

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  • WARNINGS AND PRECAUTIONS

    • Do not swallow.
    • Keep out of reach of children.
    • Contents under pressure.
    • Do not place in hot water or near radiators, stoves or other sources of heat.
    • Do not puncture or incinerate container. Do not spray towards open flames.
    • For professional use only.
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  • INSTRUCTIONS FOR USE

    • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
    • To dispense,invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
    • Air dry teeth thoroughly and inset tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
    • Use a saliva ejector during treatment to minimize ingestion of product.
    • Remove the tray(s) and have patient expectorate.
    • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.
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  • STORAGE AND HANDLING

    Store at a controlled room temperature 59o-86oF (15o-30o C)

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  • INGREDIENTS AND APPEARANCE
    IONITE APF  FOAM
    sodium fluoride aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-250
    Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5498 g  in 126 g
    Inactive Ingredients
    Ingredient Name Strength
    CASTOR OIL (UNII: D5340Y2I9G)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53045-250-44 126 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/22/2013
    Labeler - Dharma Research, inc. (078444642)
    Registrant - Dharma Research, inc. (078444642)
    Establishment
    Name Address ID/FEI Business Operations
    Dharma Research, inc. 078444642 manufacture(53045-250)
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