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Ionite APF Foam

Generic Name: sodium fluoride
Dosage Form: foam

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.

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-30o C)

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)
Revised: 04/2013
 
Dharma Research, inc.



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