CloSYS
Hydrogen Peroxide · Rinse · Oral, Dental
Active ingredient
ACTIVE INGREDIENT: Sodium fluoride 0.21% (0.11% w/v fluoride ion)
Purpose
PURPOSE: Anticavity
Uses
USES: aids in the prevention of dental decay
Warnings
WARNINGS: Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
DIRECTIONS: Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: · instruct in good brushing and rinsing habits (to minimize swallowing). · supervise children as necessary until capable of using without supervision. · do not swallow Children under 2 years of age: Consult a dentist or doctor
Inactive ingredients
INACTIVE INGREDIENTS: water, hydrated silica, stabilized chlorine dioxide, cellulose gum, disodium hydrogen phosphate, titanium dioxide, peppermint oil, sodium dihydrogen phosphate, sodium myristoyl sarcosinate (coconut derived), sucralose, menthol crystals
Questions?
Questions or comments? Call 1-800-643-3337
Label text from the FDA structured product label by Rowpar Pharmaceuticals, Inc. (revised Mar 31, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 3 products
- Hydrogen Peroxide in 1 product
CloSYS NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 58578-0613 | Hydrogen Peroxide 1.5 g/100mL Rinse | Rowpar Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 58578-0749 | Sodium Fluoride 1.1 mg/g Paste, Dentifrice | Rowpar Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 58578-0759 | Sodium Fluoride .916 mg/g Paste, Dentifrice | Rowpar Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 58578-1234 | Sodium Fluoride .05 g/100mL Rinse | Rowpar Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
Frequently asked questions
What is CloSYS used for?
USES: aids in the prevention of dental decay
Who makes CloSYS?
CloSYS is listed by 1 labeler in the FDA NDC directory, including Rowpar Pharmaceuticals, Inc..