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

Indication(s)

INDICATIONS AND USAGE Topex® Fluoride Foams 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.

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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 can. If this is the first time using can, break the protective shipping tab by gently lifting up the trigger. 2. Shake can thoroughly for at least 10 seconds before each use. 3. Completely invert can and slowly depress trigger to dispense foam into a fluoride tray 4. Air dry teeth thoroughly and insert tray into patient’s mouth. Have patient close into the tray and use a slight chewing motion to ensure interproximal coverage. 5. Leave tray in contact with teeth between 1-4 minutes. Use a saliva ejector during treatment to minimize ingestion of product 6. Remove tray after elapsed time and have patient expectorate. Instruct patient to refrain from drinking, eating, or rinsing for 30 minutes after treatment. Treatment frequency should not exceed 4 treatments per year.

More information

Category Value
Agency product number 8ZYQ1474W7
Orphan designation No
Product NDC 0699-0152,0699-0153,0699-0150,0699-0151,0699-0154
Date Last Revised 21-12-2017
Type HUMAN PRESCRIPTION DRUG
Storage and handling STORAGE AND HANDLING Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]
Marketing authorisation holder Dentsply LLC. Professional Division Trading as "Sultan Healthcare"