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Ionite APF Gel

Generic name: sodium fluoride
Dosage form: dental gel

Medically reviewed by Drugs.com. Last updated on Nov 1, 2020.

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


Citric Acid, FD & C Green No. 3 (C.I. 42053), FD & C Yellow No. 5 (C.I. 19140), Flavor, 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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53045-235
Route of Administration DENTAL, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 4.41 g in 490 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C GREEN NO. 3
FD&C YELLOW NO. 5
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
POTASSIUM HYDROXIDE
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE, DL-
XANTHAN GUM
XYLITOL
Product Characteristics
Color Score
Shape Size
Flavor MINT (Mint Parfait) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:53045-235-17 490 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 Operations
Dharma Research, inc. 078444642 manufacture(53045-235)
Dharma Research, inc.

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