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FDA LABEL GENERIC: Sodium Fluoride MFR: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

Gelato 0.02 Mg/mg Oral Gel

Table of Contents

Active ingredient: Purpose:
Indications and usage:
Warnings:
Dosage and administration:
Other information:
Inactive ingredients:
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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, Manesium 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.