Topex 60 Second Fluoride Gel

For topical application to aid in the prevention of dental caries.

Treatment frequency should not exceed 4 treatments per year.

1. DO NOT USE IF SEAL IS BROKEN. Shake well before using.

2. Fill applicator tray no more than 1/3 full with Fluoride gel.

3. Dry tooth surface and insert tray in mouth.

4. Use suction throughout treatment.

5. Have patient bite down for a minimum of 60 seconds to a maximum of 4 minutes. (A slight biting or chewing motion will provide interproximal coverage)

6. Remove tray and have patient expectorate excess gel. Do not swallow.

7. Instruct patient not to eat, drink, or rinse for 30 minutes after treatment.

This topical gel contains 1.23% sodium fluoride ion.

Hypersensitivity to fluoride. Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.

• Do not swallow. Harmful if swallowed.
• Keep out of reach of children.
• May contain FD&C Yellow #5 or FD&C Yellow #6.
• This product is not intended for home or unsupervised consumer use.
• Safety and effectiveness below age 3 have not been

established. There have been no long-term animal studies
with this product to evaluate carcinogenic, mutagenic, or
impairment of fertility potential. Laboratory studies have
indicated that repeated use of APF may dull porcelain,
composite restorations and sealants.

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticarial, gastric distress, headache, and weakness.

If treatment dose is swallowed (less than 100 mg F), administer milk, limewater, or calcium-type antacid. In case of larger doses (1 pint contains 4.5 grams F ion, which is a lethal dose), use ipecac syrup emetic and immediately seek medical help.

Topex® Fluoride Gels are a family of topical fluoride gel products for professional application in trays.

Store between 68° - 77°F (20° - 25°C). Do not allow to freeze.

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