do not swallow supervise children as necessary until capable of using without supervision Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 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 a doctor. Children under 2 years of age: Consult a dentist doctor.
Drug Facts
Sodium Fluoride 0.22%
(0.1% w/v fluoride ion)
Anticavity toothpaste
aids in the prevention of dental cavities
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.
sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharin, sodium methyl paraben, sodium propyl paraben.
BrightSmiles
Fluoride Gel Toothpaste
NET WT. 1.5 oz (42g)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71074-109-41 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-194e-f424-e053-dadaa90a57ce | Bright Smiles |
| 71074-109-42 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-194e-f424-e053-dadaa90a57ce | Bright Smiles |
| 71074-109-43 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-194e-f424-e053-dadaa90a57ce | Bright Smiles |
| 71074-109-44 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-194e-f424-e053-dadaa90a57ce | Bright Smiles |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71074-109-41 | Bright Smiles | 7.9 g in 1 TUBE | GEL, DENTIFRICE | 7.9 | 1 | |
| 71074-109-42 | Bright Smiles | 17 g in 1 TUBE | GEL, DENTIFRICE | 17 | 1 | |
| 71074-109-43 | Bright Smiles | 24 g in 1 TUBE | GEL, DENTIFRICE | 24 | 1 | |
| 71074-109-44 | Bright Smiles | 42 g in 1 TUBE | GEL, DENTIFRICE | 42 | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71074-109 | 71074-109-41, 71074-109-42, 71074-109-43, 71074-109-44 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Sodium Fluoride | 8ZYQ1474W7 | ACTIM |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| METHYLPARABEN SODIUM | CR6K9C2NHK | IACT |
| PROPYLPARABEN SODIUM | 625NNB0G9N | IACT |
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 |
|---|---|---|---|---|---|---|
| 399ab9a0-bbcc-49be-9af8-c7e7c2b5c4f0 | dcf7a177-c353-4d4f-aab3-c58f574be11c | 2017-01-27 | Warnings | 399ab9a0-bbcc-49be-9af8-c7e7c2b5c4f0 dcf7a177-c353-4d4f-aab3-c58f574be11c |
Adverse event summaries are temporarily unavailable. Other product information remains available.