OTC - ACTIVE INGREDIENT SECTION
Sodium monofluorophosphate
Glancure Tooth
- Manufacturer
- K.Boeun Pharmaceutical Co.,Ltd.
- Effective date
- 2020-09-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:29:21
Label at a glance#
ProductGlancure Tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
Silicon Dioxide, D-Sorbitol Solution, Water, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthan ?Gum, Peppermint Oil, Flavor, Enzymatically Modified Stevia, Citrus Paradisi (Grapefruit) Seed Extract, Raspberry Extract, Xylitol, L-Menthol, Red Cabbage Color, Lavender Oil, Chamomile Extract, Eucalyptus Extract
OTC - PURPOSE SECTION
for dental care
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF THE CHILDREN
INDICATIONS & USAGE SECTION
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 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
WARNINGS SECTION
Do not swallow.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
For dental use only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 74724-0015-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a7e7-d83d-e063-dadaa90ab31f | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 74724-0015-1 | Glancure Tooth | 40 g in 1 TUBE | PASTE | 40 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 74724-0015 | GLANCURE TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE [K.BOEUN PHARMACEUTICAL CO.,LTD.] | 1 | Legacy NDC, 1 package rows | 20200915_af548050-c2b9-a847-e053-2995a90a6105.zip |
Products#
Every source-derived product name is available through these pages.
- Glancure Tooth
- Sodium monofluorophosphate
- XANTHAN GUM
- XYLITOL
- FLUORIDE ION
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 74724-0015 | 74724-0015-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| XANTHAN GUM | TTV12P4NEE | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| SODIUM MONOFLUOROPHOSPHATE | C810JCZ56Q | ACTIM |
| SILICON DIOXIDE | ETJ7Z6XBU4 | 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 |
|---|---|---|---|---|---|---|
| af545c24-f82c-a23e-e053-2995a90abde5 | af548050-c2b9-a847-e053-2995a90a6105 | 2020-09-15 | Warnings | af545c24-f82c-a23e-e053-2995a90abde5 af548050-c2b9-a847-e053-2995a90a6105 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.