Drugplain

CloSYS Fluoride Rinse .05 g/100mL

Sodium Fluoride · RINSE · Rowpar Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage
Plain English

CloSYS Fluoride Rinse is a rinse containing sodium fluoride at .05 g/100mL, taken oral. Manufactured by Rowpar Pharmaceuticals, Inc..

Key Facts

Brand Name
CloSYS Fluoride Rinse
Generic Name
Sodium Fluoride
NDC Code (Product)
58578-1234
Manufacturer
Rowpar Pharmaceuticals, Inc.
Strength
.05 g/100mL
Dosage Form
RINSE
Route
ORAL
Marketing Status
Application #
M021
Marketing Start
02/18/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

pyrexia170 reports
fatigue159 reports
nausea158 reports
vomiting156 reports
pain155 reports
weight increased154 reports
nasopharyngitis152 reports
type 2 diabetes mellitus145 reports
peripheral swelling144 reports
urticaria144 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE: Aids in the prevention of dental cavities

Dosage & Administration

DIRECTIONS: Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste · remove cap · pour out and vigorously swish 10 ml (2 tsp) of rinse between your teeth for 1 minute and then spit out · do not swallow the rinse · do not eat or drink for 30 minutes after rinsing • 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.

Warnings

WARNING:

Frequently Asked Questions

What is CloSYS Fluoride Rinse used for?

CloSYS Fluoride Rinse contains Sodium Fluoride. It is a rinse taken oral. Consult your doctor for specific uses.

Is CloSYS Fluoride Rinse a controlled substance?

CloSYS Fluoride Rinse is not classified as a controlled substance by the DEA.

What is the generic name for CloSYS Fluoride Rinse?

The generic name for CloSYS Fluoride Rinse is Sodium Fluoride. There are 12 other brand versions of Sodium Fluoride.

What is the NDC code for CloSYS Fluoride Rinse .05 g/100mL?

The NDC (National Drug Code) for CloSYS Fluoride Rinse .05 g/100mL is 58578-1234, listed by Rowpar Pharmaceuticals, Inc..