Gelato APF

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

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient:
• Purpose:
• Gelato APF Indications and Usage:
• Warnings:
• Instructions for Use:
• Inactive Ingredients:
• Other Information:

FULL PRESCRIBING INFORMATION

Active Ingredient:

1.23% Fluoride Ion. Available from 1.81% Sodium Fluoride and Hydrofluoric Acid.

Purpose:

Fluoride Preventative Treatment Foam.

Indications and Usage:

This is a prescription fluoride treatment foam used to help prevent dental decay.

Warnings:

Do not swallow. Keep out of reach of children. Contents under pressure. Do not place in hot water or near radiators, stoves or other sources of heat. Do not puncture or incinerate container. Do not spray toward open flame. For Professional Use Only.

Instructions for Use:

• Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
• To dispense, invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than the fluoride tray).
• Air dry teeth thoroughly and insert tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
• Use a saliva ejector during treatment to minimize ingestion of product.
• Remove tray(s) and have patient expectorate.
• Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Inactive Ingredients:

Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Sodium Benzoate, Sodium Laureth Sulfate, Sodium Saccharine, Triethanolamine, Xylitol, Propellant A31.

Other Information:

Store at controlled room temperature 59°-86°F (15°-30°C).

Protect from freezing.

Shake well before each use.

Invert can completely and depress nozzle to dispense.