Drugplain

CloSYS 1.1 mg/g

Sodium Fluoride · PASTE, DENTIFRICE · Rowpar Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage
Plain English

CloSYS is a paste, dentifrice containing sodium fluoride at 1.1 mg/g, taken dental. Manufactured by Rowpar Pharmaceuticals, Inc..

Key Facts

Brand Name
CloSYS
Generic Name
Sodium Fluoride
NDC Code (Product)
58578-0749
Manufacturer
Rowpar Pharmaceuticals, Inc.
Strength
1.1 mg/g
Dosage Form
PASTE, DENTIFRICE
Route
DENTAL, ORAL
Marketing Status
Application #
M021
Marketing Start
10/20/2017

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea202 reports
fatigue196 reports
pyrexia193 reports
vomiting190 reports
pain177 reports
weight increased160 reports
nasopharyngitis159 reports
weight decreased158 reports
pneumonia155 reports
dizziness150 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 dental. 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 1.1 mg/g?

The NDC (National Drug Code) for CloSYS 1.1 mg/g is 58578-0749, listed by Rowpar Pharmaceuticals, Inc..