Label: IONITE APF FOAM- sodium fluoride aerosol, foam

  • Category: HUMAN PRESCRIPTION DRUG LABEL

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Drug Label Information

Updated October 27, 2020

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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

  • 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.
  • 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.
  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    RevB.jpg

  • INGREDIENTS AND APPEARANCE
    IONITE APF  FOAM
    sodium fluoride aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53045-250
    Route of AdministrationDENTAL, TOPICAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5498 g  in 126 g
    Inactive Ingredients
    Ingredient NameStrength
    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    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53045-250-44126 g in 1 BOTTLE; Type 0: Not a Combination Product04/22/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/22/2013
    Labeler - Dharma Research, Inc. (078444642)
    Registrant - Dharma Research, Inc. (078444642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Research, Inc.078444642manufacture(53045-250)
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