Prescribing information (package insert) - Iris 60 Second APF
Active Ingredients:
1.23% Fluoride Ion
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 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 of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
- After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
- Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
- 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, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol