Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habtis (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Sodium fluoride 0.243%
(0.14 w/v fluoride ion)
Anticavity
Aids in the prevention of dental cavities
Warnings
Do not swallow
Do not use in eye area
If more than used for brushing is swallowed, get medical help or contact a Poison Control Center right away.
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing and rinsing habtis (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
Water
Sorbitol
Glycerin
Hydrated Silica
Xylitol
Sodium Phosphate
Xanthan Gum
Sodium Lauroyl Sarcosinate
Tetrapotassium Pyrophosphate
1,2-Hexanediol
Cellulose Gum
Sucralose
Lauryl Glucoside
Methyl Diisopropyl Propionamide
Sodium Gluconate
Zinc Lactate
D&C Red No. 33
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44038-0324 | HISMILE (SODIUM FLUORIDE) GEL [ACCUPAC LLC] | 3 | Unmatched | 20250507_227a0fee-771c-3cd1-e063-6394a90af7f3.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 44038-0324 | 44038-0324-1 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 28737ea0-e457-49c1-e063-6294a90a51d6 | 227a0fee-771c-3cd1-e063-6394a90af7f3 | 2024-12-04 | Warnings | 28737ea0-e457-49c1-e063-6294a90a51d6 227a0fee-771c-3cd1-e063-6394a90af7f3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.