PURELIFE APF- sodium fluoride aerosol, foam 
PureLife Dental

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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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.

PLFoamStrawberry

PURELIFE APF 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68987-020
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5375 g  in 125 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68987-020-12125 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/27/2013
Labeler - PureLife Dental (828690904)

Revised: 5/2014
 
PureLife Dental