FDA Label for Ionite Apf
View Indications, Usage & Precautions
Ionite Apf Product Label
The following document was submitted to the FDA by the labeler of this product Dharma Research, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Inactive Ingredient
Citric Acid, FDandC Red No. 40 (C.I. 16035), 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.
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.
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
* Please review the disclaimer below.