IONITE APF FOAM- sodium fluoride aerosol, foam

Ionite APF by

Drug Labeling and Warnings

Ionite APF by is a Prescription medication manufactured, distributed, or labeled by Dharma Research, inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INACTIVE INGREDIENT

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

WARNINGS AND PRECAUTIONS

• 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.

INSTRUCTIONS FOR USE

• 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.

STORAGE AND HANDLING

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

PRINCIPAL DISPLAY PANEL

2013 53045_251.jpg

2013 53045_251.jpg

INGREDIENTS AND APPEARANCE

IONITE APF  FOAM
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 53045-251
Route of Administration	DENTAL, TOPICAL, ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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	GRAPE (Concord Grape)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53045-251-44	126 g in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2013

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	Business Operations
Dharma Research, inc.		078444642	manufacture(53045-251)