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 teaspoonfuls) 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 neces...
do not use if safety seal is broken or missing
Sodium fluroide 0.05% (0.02% w/v fluoride ion)
Anticavity
Use: Aids in the prevention of dental cavities
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
adults and children 6 years of age and older:
Children under 6 years of age: consult a dentist or doctor
water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose
Questions or comments? Call 1-800-643-3337
Specially formulated For Adults 55+
Non-Irritating: for Sensitive Mouths
•Alcohol-Free • Sulfate-Free
• Non-Burning • Non-Irritating
Gentle MINT FLAVOR with Fluoride
CloSYS SilverTM helps with:
• Mild to moderate sensitivity & dry mouth
• Strengthening enamel
• Anticavity protection
• Dentist recommended to help relieve discomfort due to canker sores or chemotherapy sores
FOR YOUR PROTECTION, this bottle has been sealed with an inner cap. DO NOT USE if the seal is broken. For maximum effectiveness, store at room temperature.
Oral Care as We Age
As we age we become more vulnerable to developing chronic diseases. Research points to possible links between adult gum conditions and various diseases like; heart disease, diabetes, stroke, pneumonia, osteoporosis, and more. CloSYS, while not a prevention or cure for these diseases, helps fight the challenges of adult oral conditions.
The CloSYS 100% Satisfaction Guarantee
It’s simple: If you’re not absolutely satisfied for any reason with CloSYS Oral Health Products we’ll refund your purchase in full.
DISTRIBUTED BY:
Rowpar Pharmaceuticals, Inc.
Scottsdale, AZ 85260
1 (800) 643-3337
closys.com
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58578-1234-2 | CloSYSFluoride Rinse | 100 mL in 1 BOTTLE | RINSE | 100 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58578-1234 | CLOSYS FLUORIDE RINSE (SODIUM FLUORIDE) RINSE [ROWPAR PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20160221_e164f877-3163-4c16-afae-ff83efb079d9.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58578-1234 | 58578-1234-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| WATER | 059QF0KO0R | IACT |
| CHLORINE DIOXIDE | 8061YMS4RM | IACT |
| SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE | B70850QPHR | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| PEPPERMINT | V95R5KMY2B | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| CloSYS Fluoride Rinse | SODIUM FLUORIDE | Rowpar Pharmaceuticals, Inc. | 1a994f24-99ee-4b27-aab0-e816931a22c8 | 2025-12-23 | Warnings | 58578-1234-2 58578-1234 58578123402 |
| 7c8f9907-c6df-4bf8-8be7-fc0540e3540d | e164f877-3163-4c16-afae-ff83efb079d9 | 2018-01-17 | Warnings | e164f877-3163-4c16-afae-ff83efb079d9 |
Adverse event summaries are temporarily unavailable. Other product information remains available.