OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride
DENTI WHOO CTS GERM FREE-F
- Manufacturer
- SUN LIFE SCIENCE CO LTD
- Effective date
- 2022-05-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:54:20
Label at a glance#
ProductDENTI WHOO CTS GERM FREE-F
Active ingredientSODIUM FLUORIDE
Label structure8 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
Sodium Fluoride
Citric Acid
Sodium Citrate
Stevioside
Xylitol
Chitosan
Citrus paradisi(Grapefruit) Fruit extract
Saponaria Officinalis Extract
hamomilla Recutita (Matricaria) Leaf Extra
Mentol
Fragnance
Glycerin
Water
OTC - PURPOSE SECTION
Tooth-decay prevention, Odor removal from the mouth
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
INDICATIONS & USAGE SECTION
Put about 10 to 15ml in your mouth, gargle for about 30 seconds, and spit it out.
WARNINGS SECTION
1.General Attention
1) Please observe the prescribed usage and capacity.
2) Do not use it for children under the age of six.
3) Use it under the supervision of guardian when using it for children over the age of seven.
4) This product contains fluorine, so if you drink it incorrectly, consult your doctor or pharmacist.
2. Storage Precautions
1) Keep out of reach of children.
2) Avoid direct sunlight and store in a cool place as much as possible.
3) Do not replace it in other containers to prevent misuse and to preserve quality.
DOSAGE & ADMINISTRATION SECTION
For dental use only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 86157-0003-1 | 2023-07-28 | C162847 | 48780-1 | 0191ceaa-6d0e-198a-e063-dbdaa90aec3e | dbf8efb8-43b0-b15e-e053-2995a90a1379 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 86157-0003-1 | DENTI WHOO CTS GERM FREE-F | 250 mL in 1 BOTTLE | LIQUID | 250 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 86157-0003 | DENTI WHOO CTS GERM FREE-F (SODIUM FLUORIDE) LIQUID [SUN LIFE SCIENCE CO LTD] | 2 | Legacy NDC, 1 package rows | 20230303_dbf8efb8-43b0-b15e-e053-2995a90a1379.zip |
Products#
Every source-derived product name is available through these pages.
- DENTI WHOO CTS GERM FREE-F
- sodium fluoride
- WATER
- XYLITOL
- GLYCERIN
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 86157-0003 | 86157-0003-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
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 |
|---|---|---|---|---|---|---|
| dfe04d1a-2215-2128-e053-2995a90a6ee3 | dbf8efb8-43b0-b15e-e053-2995a90a1379 | 2022-05-25 | Warnings | dfe04d1a-2215-2128-e053-2995a90a6ee3 dbf8efb8-43b0-b15e-e053-2995a90a1379 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.