Label: IONITE APF- sodium fluoride gel

  • 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 January 1, 2013

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

  • STORAGE AND HANDLING

    • Store at 59o - 86oF (15o - 30oC)
    • Protect from freezing
    • Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
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  • INACTIVE INGREDIENT


    Citric Acid, Flavor, Hydrofluoric Acid, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan Gum, Xylitol.

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  • WARNINGS AND PRECAUTIONS

    • Keep out of the reach of children.
    • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
    • Do not use on patients with an allergy Fluoride.
    • Ionite APF Gel contains artificial color, confirm that no kno.wn patient allergies exist.
    • For professional use only.

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  • INSTRUCTIONS FOR USE

    • Shake well before use.
    • This is a four minute or one minute Fluoride gel for in-office patient use.
    • For best results, use at least twice a year.
    • After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
    • Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness)
    • Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes
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  • INGREDIENTS AND APPEARANCE
    IONITE APF 
    sodium fluoride gel
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-207
    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 6.027 g  in 490 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    HYDROFLUORIC ACID (UNII: RGL5YE86CZ)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor VANILLA (French Vanilla) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53045-207-17 490 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/01/2013
    Labeler - Dharma Research, inc. (078444642)
    Registrant - Dharma Research, inc. (078444642)
    Establishment
    Name Address ID/FEI Business Operations
    Dharma Research, inc. 078444642 manufacture(53045-207)
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