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Ionite APF Foam

Package insert / prescribing information
Generic name: sodium fluoride
Dosage form: foam
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Oct 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. Read further information about unapproved drugs.

Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

  • Do not swallow.
  • Keep out of reach of children.
  • Contents under pressure.
  • Do not place in hot water or near radiators, stoves or other sources of heat.
  • Do not puncture or incinerate container. Do not spray towards open flames.
  • For professional use only.
  • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
  • To dispense,invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
  • Air dry teeth thoroughly and inset tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
  • Use a saliva ejector during treatment to minimize ingestion of product.
  • Remove the tray(s) and have patient expectorate.
  • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Store at a controlled room temperature 59o-86oF (15o-30oC).

IONITE APF FOAM
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53045-253
Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5498 g in 126 g
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL
DECYL GLUCOSIDE
WATER
HYDROFLUORIC ACID
PHOSPHORIC ACID
SODIUM BENZOATE
SODIUM LAURETH SULFATE
SACCHARIN SODIUM
XYLITOL
POLOXAMER 407
TROLAMINE
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY (Strawberry Shortcake) Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:53045-253-44 126 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/22/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
Name Address ID/FEI Operations
Dharma Research, inc. 078444642 manufacture(53045-253)
Dharma Research, inc.