Ionite APF

IONITE APF- sodium fluoride gel
Dharma Research, inc.

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 — 86o F (15o — 30o C)
  • Protect from freezing
  • Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products


Citric Acid, FD & C Red No. 40 (C.I. 16035), Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xanthan 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 APF Gel contains artificial color, confirm that no kno.wn 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

20200514_202_RevB
(click image for full-size original)

IONITE APF
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53045-202
Route of Administration DENTAL, 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
CITRIC ACID MONOHYDRATE
FD&C RED NO. 40
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
WATER
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE, DL-
XANTHAN GUM
XYLITOL
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53045-202-17 490 g in 1 BOTTLE None
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 (53045-202)

Revised: 11/2020 Dharma Research, inc.

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