PURELIFE APF- sodium fluoride aerosol, foam

PureLife APF by

Drug Labeling and Warnings

PureLife APF by is a Prescription medication manufactured, distributed, or labeled by PureLife Dental. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

1.23% Fluoride Ion.

Available from 1.81% Sodium Fluoride and Hydrofluoric Acid.

Purpose:

Fluoride Preventative Treatment Foam.

Indications and Usage:

This is a prescription fluoride treatment foam used to help prevent dental decay.

Warnings:

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 toward open flame. 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 fluoride tray (foam will expand slightly higher than the tray).
• Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth for 1-4 minutes.
• Use a saliva ejector during treatment to minimize ingestion of the product.
• Remove tray(s) and have patient expectorate.
• Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Inactive Ingredients

Distilled Water, Flavor, Hydrofluoric Acid, Isobutane Propane Propellant, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharin, Triethanolamine, Xylitol.

Other Information:

Store at controlled room temperature 59°-86°F (15°-30°C).

Protect from freezing.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PURELIFE APF 
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 68987-021
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5375 g  in 125 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
HYDROFLUORIC ACID (UNII: RGL5YE86CZ)
PHOSPHORIC ACID (UNII: E4GA8884NN)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TROLAMINE (UNII: 9O3K93S3TK)
XYLITOL (UNII: VCQ006KQ1E)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68987-021-12	125 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/27/2013

Labeler - PureLife Dental (828690904)