Your browser does not support JavaScript! IONITE APF FOAM (SODIUM FLUORIDE) AEROSOL, FOAM [DHARMA RESEARCH, INC.]
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RxNorm Names

IONITE APF FOAM (sodium fluoride) aerosol, foam
[Dharma Research, inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

Entire Label

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

IONITE APF  FOAM
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:53045-251
Route of AdministrationDENTAL, TOPICAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5498 g  in 126 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL 
DECYL GLUCOSIDE 
WATER 
HYDROFLUORIC ACID 
PHOSPHORIC ACID 
SODIUM BENZOATE 
SODIUM LAURETH SULFATE 
SACCHARIN SODIUM 
XYLITOL 
POLOXAMER 407 
TROLAMINE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Concord Grape) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53045-251-44126 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/22/2013
Labeler - Dharma Research, inc. (078444642)
Registrant - Dharma Research, inc. (078444642)
Establishment
NameAddressID/FEIBusiness Operations
Dharma Research, inc.078444642manufacture(53045-251)

Revised: 4/2013
 
Dharma Research, inc.

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