Ionite APF Gel
Generic Name: sodium fluoride
Dosage Form: dental gel
Medically reviewed on February 1, 2018
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.
Store at 59
o - 86 oF (15 o - 30 oC) Protect from freezing
Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products
Citric Acid, Flavor, Hydrofluoric Acid, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham Gum, Xylitol.
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 Neutral Gel contains artificial color, confirm that no known patient allergies exist.
For professional use only.
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
IONITE APF NEUTRAL
sodium fluoride gel
HUMAN PRESCRIPTION DRUG LABEL
Item Code (Source)
Route of Administration
DENTAL, TOPICAL, ORAL
Active Ingredient/Active Moiety
Basis of Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION
4.41 g in 490 g
ANHYDROUS CITRIC ACID
magnesium aluminum silicate
.ALPHA.-TOCOPHEROL ACETATE, DL-
MINT (Mint Parfait)
490 g in 1 BOTTLE
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
unapproved drug other
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Dharma Research, inc.
Dharma Research, inc.