Label: IONITE APF- sodium fluoride gel 

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

Drug Label Information

Updated 01/13

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 LABEL Item Code (Source) NDC:53045-207
    Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 6.027 g  in 490 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    MAGNESIUM ALUMINUM SILICATE  
    FD&C RED NO. 40  
    SACCHARIN SODIUM  
    SODIUM BENZOATE  
    TITANIUM DIOXIDE  
    XYLITOL  
    ANHYDROUS CITRIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    XANTHAN GUM  
    CARBOMER HOMOPOLYMER TYPE C  
    PHOSPHORIC ACID  
    HYDROFLUORIC ACID  
    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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