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Purelife APF

Generic Name: sodium fluoride
Dosage Form: gel

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.

Active Ingredient

Fluoride Ion 1.23%.

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Purpose

Anticaries Treatment

Indications and Usage

  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.

Warnings

  • Keep out of reach of children.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
  • Read directions carefully before using.

Dosage and Administration

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxis, fill two single or one dual try, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information

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

Protect from freezing.

Inactive Ingredients

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.

Purelife APF 
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68987-011
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 5.6 g  in 454 g
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
FD&C GREEN NO. 3  
FD&C YELLOW NO. 5  
TITANIUM DIOXIDE  
MAGNESIUM ALUMINUM SILICATE  
PHOSPHORIC ACID  
POLYSORBATE 20  
SODIUM BENZOATE  
SACCHARIN SODIUM  
WATER  
XANTHAN GUM  
XYLITOL  
Product Characteristics
Color green Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68987-011-15 454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/18/2012
Labeler - PureLife Dental (828690904)
Revised: 05/2014
 
PureLife Dental



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