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 supervi...
Sodium fluoride 0.05% (0.02% w/v fluoride ion)
Anticavity
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.
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.
Do not use if safety seal is broken or missing
water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose
Questions or comments? Call 1-800-643-3337
473ml Inner Label
473 mL Carton
100 ml Label
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0647692627018 | GTIN-13: 0647692627018 EAN-13: 0647692627018 GTIN-12: 647692627018 UPC-A: 647692627018 GTIN storage (14 digits): 00647692627018 | 100mlbottle.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58578-1234-1 | CloSYSFluoride Rinse | 1 in 1 BOX | RINSE | 1 | 8 | |
| 58578-1234-1 | CloSYSFluoride Rinse | 473 mL in 1 BOTTLE | RINSE | 473 | 8 | |
| 58578-1234-2 | CloSYSFluoride Rinse | 100 mL in 1 BOTTLE | RINSE | 100 | 8 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58578-1234 | 58578-1234-1, 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 | 58578-1234-1 58578-1234-2 58578-1234 58578123401 58578123402 42ecdcc7-82b3-49f6-bff8-0b38c247433e 1a994f24-99ee-4b27-aab0-e816931a22c8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.