Prescribing information (package insert) - Gelato APF
Active ingredient: Purpose:
Fluoride Ion 1.23% .................................Fluoride Treatment Gel
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
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 twice a year.
- 1. After thorough prophylaxis, 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:
- Do not store above 25°C/77°F. Do not freeze.
Inactive ingredients:
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.