Data from FDA - Curated by EPG Health - Last updated 31 December 2017

Indication(s)

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.

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Advisory information

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

Usage information

Dosing and administration
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.

More information

Category Value
Agency product number Q80VPU408O
Orphan designation No
Product NDC 0699-0702,0699-0701
Date Last Revised 27-11-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling STORAGE AND HANDLING Store between 68° - 77°F (20° - 25°C). Do not allow to freeze.
Marketing authorisation holder Dentsply LLC. Professional Division Trading as "Sultan Healthcare"