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:53045-253
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
STRAWBERRY (Strawberry Shortcake)
Imprint Code
Contains
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:53045-253-44
126 g in 1 BOTTLE; Type 0: Not a Combination Product