Document
DailyMed Label: Topex 60 Second Fluoride Foam
Title
DailyMed Label: Topex 60 Second Fluoride Foam
Date
2024
Document type
DailyMed Prescription
Name
Topex 60 Second Fluoride Foam
Generic name
sodium fluoride
Manufacturer
Dentsply LLC. Professional Division Trading as "Sultan Healthcare"
Product information
NDC: 0699-0151
Product information
NDC: 0699-0150
Product information
NDC: 0699-0152
Product information
NDC: 0699-0153
Product information
NDC: 0699-0154
Product information
NDC: 0699-0152
Product information
NDC: 0699-0152
Product information
NDC: 0699-0153
Product information
NDC: 0699-0153
Product information
NDC: 0699-0151
Product information
NDC: 0699-0151
Product information
NDC: 0699-0154
Product information
NDC: 0699-0154
Product information
NDC: 0699-0150
Product information
NDC: 0699-0150
Description
Topex® Fluoride Foams are a family of topical fluoride foam products for professional application in trays. The family consists of APF Foam (1.23% fluoride ion at a pH between 3.0-4.5) and Neutral pH Foam (0.9% fluoride ion at a pH between 6.5 -7.5). Topex® Foam Fluoride products do not contain chlorofluorocarbon propellants.
Indications
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.
Dosage
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.
Dosage forms
APF topical Foam contains 2.73% 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
Do not swallow. Harmful if swallowed.
Keep out of reach of children.
This product is not intended for home or unsupervised consumer use.
Contents under pressure. Do not puncture or incinerate canister.
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.
Package label
strawberry
1 organization
1 product
Product
Sodium Fluoride F 18