Gelato X APF

Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient:
• Purpose:
• Gelato X APF Indications and Usage:
• Warnings:
• Dosage and Administration:
• Other Information:
• Inactive Ingredients:

FULL PRESCRIBING INFORMATION

Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

Anticaries Treatment

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.

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 two times 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:

• Store at a controlled room temperature 59°-86°F (15°-30°C).
• Protect from freezing.

Inactive Ingredients:

Citric Acid, FD&C Blue #1, FD&C Red #40, FD&C Yellow #5 (tartrazine) as a color additive, FD&C Yellow #6, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol