OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride
Seavue Anti-caries Gel
- Manufacturer
- Xiling (Zhenjiang) Medical Technology Co., Ltd.
- Effective date
- 2025-09-21
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:38:05
Label at a glance#
ProductSeavue Anti-caries Gel
Active ingredientSODIUM FLUORIDE
Label structure11 sections
Label contents#
Full prescribing information#
OTC - ASK DOCTOR SECTION
Do not use in children under 6 years of age unless directed by a dentist or physician.
OTC - DO NOT USE SECTION
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children under 6 years of age.
OTC - PURPOSE SECTION
Anticavity
OTC - WHEN USING SECTION
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
DOSAGE & ADMINISTRATION SECTION
Sodium fluoride 0.3% (w/w)
Aids in the prevention of dental cavities and helps strengthen tooth enamel.
WARNINGS SECTION
For oral use only
Keep out of reach of children under 6 years of age.
Do not use in children under 6 years of age unless directed by a dentist or physician.
Avoid contact with eyes and skin. If contact occurs, rinse thoroughly with water.
Do not use for deep cavities close to the pulp unless directed by a dentist.
Do not use if the safety seal is broken or missing.
INACTIVE INGREDIENT SECTION
Carbomer, Glycerin, Potassium Nitrate, Triethanolamine, Purified Water
INDICATIONS & USAGE SECTION
Directions
Tray Method:
Rinse mouth and clean teeth before use.
Fill dental tray evenly with gel and place over dental arch.
Leave in place for 5 minutes.
Remove tray, spit out gel, and rinse mouth thoroughly.
Brush Method:
Apply a small amount of gel evenly to teeth using a toothbrush or cotton swab.
Leave on for 3–5 minutes.
Rinse mouth thoroughly.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 87118-004-01 | Seavue Anti-caries Gel | 1 g in 1 BOX | GEL | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Seavue Anti-caries Gel
- Sodium fluoride
- CARBOMER
- FLUORIDE ION
- GLYCERIN
- TRIETHANOLAMINE
- WATER
- POTASSIUM NITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 87118-004 | 87118-004-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOMER | 0A5MM307FC | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| GLYCERIN | PDC6A3C0OX | IACT |
| TRIETHANOLAMINE | 9O3K93S3TK | IACT |
| WATER | 059QF0KO0R | IACT |
| POTASSIUM NITRATE | RU45X2JN0Z | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| Seavue Anti-caries Gel | SODIUM FLUORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4c6086-b96d-8fa4-e063-6294a90ad800 | 2025-09-21 | Warnings | 87118-004-01 87118-004 87118000401 3f4c6086-b96e-8fa4-e063-6294a90ad800 3f4c6086-b96d-8fa4-e063-6294a90ad800 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.