IONITE APF FOAM- sodium fluoride aerosol, foam
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.

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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	Item Code (Source)	NDC:53045-250
Route of Administration	DENTAL, TOPICAL, ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5498 g in 126 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XYLITOL (UNII: VCQ006KQ1E)
POLOXAMER 407 (UNII: TUF2IVW3M2)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53045-250-44	126 g in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		04/22/2013

Labeler - Dharma Research, Inc. (078444642)

Registrant - Dharma Research, Inc. (078444642)

Name	Address	ID/FEI	Business Operations
Establishment
Dharma Research, Inc.		078444642	manufacture(53045-250)