CloSYS .916 mg/g
Sodium fluoride · PASTE, DENTIFRICE · Rowpar Pharmaceuticals, Inc.
CloSYS is a paste, dentifrice containing sodium fluoride at .916 mg/g, taken oral. Manufactured by Rowpar Pharmaceuticals, Inc..
Key Facts
- Brand Name
- CloSYS
- Generic Name
- Sodium fluoride
- NDC Code (Product)
58578-0759- Manufacturer
- Rowpar Pharmaceuticals, Inc.
- Strength
- .916 mg/g
- Dosage Form
- PASTE, DENTIFRICE
- Route
- ORAL
- Marketing Status
- Application #
- M021
- Marketing Start
- 01/06/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses Helps prevent and reduce plaque and gingivitis. Helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums.
Dosage & Administration
Directions Adults and children 12 years and over Vigorously swish 20 milliliters of rinse between your teeth for 30 seconds and then spit out. Do not swallow rinse. Children 6 years to under 12 years Supervise use. Children under 6 years Do not use.
Warnings
Warnings Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Frequently Asked Questions
What is CloSYS used for?
CloSYS contains Sodium fluoride. It is a paste, dentifrice taken oral. Consult your doctor for specific uses.
Is CloSYS a controlled substance?
CloSYS is not classified as a controlled substance by the DEA.
What is the generic name for CloSYS?
The generic name for CloSYS is Sodium fluoride. There are 12 other brand versions of Sodium fluoride.
What is the NDC code for CloSYS .916 mg/g?
The NDC (National Drug Code) for CloSYS .916 mg/g is 58578-0759, listed by Rowpar Pharmaceuticals, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)