Data from FDA - Curated by EPG Health - Last updated 31 December 2017

Indication(s)

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.

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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 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.

More information

Category Value
Agency product number 8ZYQ1474W7
Orphan designation No
Product NDC 69301-027
Date Last Revised 26-12-2017
Type HUMAN PRESCRIPTION DRUG
List of excipients 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
Marketing authorisation holder Top Quality Manufacturing, Inc.