Prescribing information (package insert) - Burkhart
Active Ingredient:
Fluoride Ion 1.23%
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid
Purpose:
Fluoride Treatment Gel
Indications and Usage:
- A stable thixotropic fluoride treatment gel used to help prevent dental decay.
- For Professional Use Only. This product is not intended for home or unsupervised 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 prophylaxsis, fill two single or one dual tray, 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 room temperature 59° to 86°F (15°-30°C).
Protect from freezing.
Inactive Ingredients:
Citric Acid, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.