Burkhart
Burkhart is an FDA drug label for the active ingredient SODIUM FLUORIDE manufactured by Burkhart Dental Supply Inc administered by DENTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20220202.
- Generic name
- SODIUM FLUORIDE
- Manufacturer
- Burkhart Dental Supply Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- DENTAL
- Dosage form
- N/A
- NDC
- 43498-105
- Application
- N/A
- Label effective
- 20220202
Indications & Usage
Indications and Usage: A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.
Dosage & Administration
Dosage and Administration: Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Contraindications
Not available.
Warnings
Warnings: Keep out of reach of children. Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away. Read directions carefully before using.
Adverse Reactions
Not available.