Indications and uses
helps protect against cavities.
Fluoride Gel
- Manufacturer
- Yangzhou Tracey Daily Chemical Plastic Co., Ltd.
- Effective date
- 2019-10-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:00:48
Label at a glance#
ProductFluoride Gel
Active ingredientSODIUM FLUORIDE
Label structure6 sections
Dosage and administration
Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician. Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years:Ask a dentist or a physician.
Label contents#
Full prescribing information#
Active ingredients
Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)
Purpose
anticavity
Uses
helps protect against cavities.
Warnings
Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Directions
Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.
Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2 years:Ask a dentist or a physician.
INACTIVE INGREDIENT
Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 73343-002-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-524c-a910-e053-dadaa90a0b85 | Charm-Tex Fluoride Gel Toothpaste 73343-002 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73343-002-01 | Fluoride Gel | 43 g in 1 TUBE | PASTE | 43 | 1 | |
| 73343-002-01 | Fluoride Gel | 1 in 1 BOX | PASTE | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Fluoride Gel
- Sodium Fluoride
- CARBOCYSTEINE LYSINE MONOHYDRATE
- SORBITOL
- SODIUM LAURYL SULFATE
- METHYL PARAOXON
- PROPYLPARABEN SODIUM
- WATER
- SODIUM SILICATE
- POTASSIUM SODIUM SACCHARATE
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 73343-002 | 73343-002-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CARBOCYSTEINE LYSINE MONOHYDRATE | QA5ZP9OL3E | IACT |
| SORBITOL | 506T60A25R | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| METHYL PARAOXON | UE1A2XL95H | IACT |
| PROPYLPARABEN SODIUM | 625NNB0G9N | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM SILICATE | IJF18F77L3 | IACT |
| POTASSIUM SODIUM SACCHARATE | 73U34YC90U | 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 |
|---|---|---|---|---|---|---|
| 94df0a78-8fd0-2d98-e053-2995a90afe14 | 94df04cc-a430-c57a-e053-2995a90a7fb4 | 2019-10-14 | Warnings | 94df0a78-8fd0-2d98-e053-2995a90afe14 94df04cc-a430-c57a-e053-2995a90a7fb4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.