Label: IONITE APF FOAM- sodium fluoride aerosol, foam

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 22, 2013

If you are a consumer or patient please visit this version.

  • 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
    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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