OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride - 0.243% (0.11% w/v fluoride ion)
Freshmint
- Manufacturer
- New World Imports, Inc
- Effective date
- 2020-10-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:10:44
Label at a glance#
ProductFreshmint
Active ingredientSodium Fluoride
Label structure8 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Anticavity
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
INDICATIONS & USAGE SECTION
Helps protect against cavities
WARNINGS SECTION
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get meidcal help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each mean or at least twice a day, or as directed by a dentist or physician.
Children 2 to 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 physician
INACTIVE INGREDIENT SECTION
Treated Water, Sorbitol, Carbopol, Sodium Lauryl Sulfate, Flavor, Polyethylene Glycol 1500, Sodium Saccharin, Precipiated Silica, Sodium Carboxymethyl Cellulose, Methylparaben, Propylparaben.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Freshmint
- Sodium Fluoride
- Fluoride Ion
- Water
- Sorbitol
- CARBOMER HOMOPOLYMER TYPE C
- Sodium Lauryl Sulfate
- Polyethylene Glycol 1500
- Saccharin Sodium
- Silicon Dioxide
- Carboxymethylcellulose Sodium
- Methylparaben
- Propylparaben
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 51824-066 | 51824-066-28, 51824-066-25 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Sodium Fluoride | 8ZYQ1474W7 | ACTIM |
| Water | 059QF0KO0R | IACT |
| Sorbitol | 506T60A25R | IACT |
| CARBOMER HOMOPOLYMER TYPE C | 4Q93RCW27E | IACT |
| Sodium Lauryl Sulfate | 368GB5141J | IACT |
| Polyethylene Glycol 1500 | 1212Z7S33A | IACT |
| Saccharin Sodium | SB8ZUX40TY | IACT |
| Silicon Dioxide | ETJ7Z6XBU4 | IACT |
| Carboxymethylcellulose Sodium | K679OBS311 | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | 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 |
|---|---|---|---|---|---|---|
| 46903e8d-f153-5ddc-e063-6394a90a354e | fd92c8b3-29dc-4a4b-b12c-fa6451d46b78 | 2025-12-22 | Warnings | fd92c8b3-29dc-4a4b-b12c-fa6451d46b78 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.