Fluoridex
Fluoridex is an FDA drug label for the active ingredient STANNOUS FLUORIDE RINSE manufactured by DEN-MAT HOLDINGS, LLC administered by ORAL. 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 20231120.
- Generic name
- STANNOUS FLUORIDE RINSE
- Manufacturer
- DEN-MAT HOLDINGS, LLC
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 59883-004
- Application
- M021
- Label effective
- 20231120
Active ingredients
Indications & Usage
Use Aids in the prevention of dental cavities
Dosage & Administration
Directions Adults and children 6 years of age and older: Do not use before mixing with water Use once a day after brushing your teeth with a toothpaste Separate provided graduated cup from the mixing cap Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate Add warm water to 1 oz. fill line Place the mixing cap onto the filled cap until it snaps closed Shake thoroughly then remove mixing cap Use immediately after preparing the rinse Vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out Do not swallow the rinse Repeat the procedure with the remaining half of the prepared solution Do not eat or drink for 30 minutes after rinising Instruct children under 12 years of age in good rinsing habits (to minimize swallowing) Supervise children as necessary until capable of using without supervision Children under 6 years of age Consult a dentist or doctor
Contraindications
Not available.
Warnings
Do not swallow the rinse
Adverse Reactions
Not available.