Data from FDA - Curated by EPG Health - Last updated 18 December 2019

Indication(s)

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.

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Usage information

Dosing and administration
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 tray(s), 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.

More information

Category Value
Agency product number 8ZYQ1474W7
Orphan designation No
Product NDC 68400-701
Date Last Revised 28-12-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 245593
List of excipients 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.
Storage and handling Other information: Store at a controlled room temperature 59° to 86°F (15°-30°C). Protect from freezing.
Marketing authorisation holder Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.