INDICATIONS AND USAGE
Topex® Fluoride Gels are indicated for topical application to teeth to aid in the prevention of dental caries.
The non-acidic nature of Neutral pH (NaF) is recommended for patients with ceramic or composite restorations.
Treatment frequency should not exceed 4 treatments per year.
DOSAGE AND ADMINISTRATION
1. Remove cap from bottle, remove induction seal. DO NOT USE IF SEAL IS BROKEN.
2. Replace cap and shake well.
3. Fill applicator tray no more than 1/3 full with Fluoride gel.
4. Dry tooth surface and insert tray in mouth.
5. Use suction throughout treatment.
6. 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)
7. Remove tray and have patient expectorate excess gel. Do not swallow.
8. Instruct patient not to eat, drink, or rinse for 30 minutes after treatment.
DOSAGE FORMS AND STRENGTHS
APF topical gel contains 2.59% sodium fluoride (1.23% fluoride ion).
NaF topical gel contains 2.0% sodium fluoride (0.9% fluoride ion).
CONTRAINDICATIONS
Hypersensitivity to fluoride. Do not use if patient has a known allergy to fluoride or any of the other ingredients in this product.
WARNINGS AND PRECAUTIONS
Do not swallow. Harmful if swallowed.
Keep out of reach of children.
May contain FD&C Yellow #5 & 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.
ADVERSE REACTIONS
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.
OVERDOSAGE
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.
DESCRIPTION
Topex® Fluoride Gels are a family of topical fluoride gel products for professional application in trays.
