PureLife APF

PureLife Dental

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• PureLife APF Indications and Usage
• Warnings
• Dosage and Administration
• Other Information
• Inactive Ingredients

FULL PRESCRIBING INFORMATION

Active Ingredient

Fluoride Ion 1.23%.

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Purpose

Anticaries Treatment

PureLife APF 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 #3, FD&C Blue #1, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.