Purelife APF Foam

Name: Purelife APF Foam

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.

Other Information

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

Protect from freezing.

PURELIFE APF 
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68987-021
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.5375 g  in 125 g
Inactive Ingredients
Ingredient Name Strength
Water  
HYDROFLUORIC ACID  
PHOSPHORIC ACID  
POLOXAMER 407  
SODIUM BENZOATE  
SODIUM LAURETH-3 SULFATE  
SACCHARIN SODIUM  
TROLAMINE  
XYLITOL  
Product Characteristics
Color white Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description
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)
Revised: 05/2014   PureLife Dental

For Healthcare Professionals

Applies to fluoride topical: mucous membrane powder for reconstitution, mucous membrane solution, topical cream, topical gel, topical kit, topical paste, topical solution, topical swab

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been reported.[Ref]

Oncologic

It has been shown that fluoride ion has potential to induce chromosome aberrations in cultured human and animal cells at doses much higher than those to which humans are exposed. In vivo data are conflicting.[Ref]

Some side effects of Purelife APF Foam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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