SPL UNCLASSIFIED SECTION
Drug Facts
Drug Facts
Active ingredient
Potassium nitrate 5.0%
Sodium fluoride 0.24%
Purpose
Potassioum nitrate .......... Desinsitizer
Sodium fluoride ............... Anticavity
Use • Aids in the prevention of dental decay.
• Helps reduce painful sensitivity of the teeth to cold,
heat, acids, sweets, or contact.
Warnings
• Sensitive teeth may indicate a serious problem that may
need prompt care by a dentist. • See your dentist if the
problem persists or worsens.
• Do not use this product longer than 4 weeks unless
recommended by a dentist or doctor.
Keep out of reach of children under 6 years of age. If
more than used for brushing is accidentally swallowed, get
medical help or contact a Poison Control Center right away.
Directions
• Adults and children 2 years of age and older: Apply at
least a 1 inch strip of the product onto a soft bristle
toothbrush. Brush teeth thoroughly for at least 1 minute
twice a day (morning and evening) or as recommended by a
dentist or doctor.
• Make sure to brush all sensitive areas of the teeth.
• Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
Sorbitol, Hydrated Silica, Water (purified), Glycerin,
Calcium Carbonate, Sodium Bicarbonate,
Cocamidopropyl Betaine, Flavor, Cellulose Gum, Sodium
Saccharin, Tricalcium Phosphate, Titanium Dioxide
Questions? +1 (646) 9806461
Spotlight
Oral Care
CREATED BY DENTISTS
R
Toothpaste
for Rebuilding
Teeth
_______ Active Ingredients _________
Sodium Potassium
Fluoride Nitrate
_______________________________
NET WT 3.5oz (100g)
MADE IN THE USA
Spotlight Oral Care, 90 South Dale, Suite #8
Saint Paul, Minnesota, USA 55102
SpotlightOralCare.com
#LoveYourSmile
Carton
Tube
res
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75065-008 | 75065-008-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POTASSIUM NITRATE | RU45X2JN0Z | ACTIB |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIB |
| SORBITOL | 506T60A25R | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CALCIUM CARBONATE | H0G9379FGK | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| COCAMIDOPROPYL BETAINE | 5OCF3O11KX | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED | K679OBS311 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| f4969ee2-edab-4366-bbe6-c9d890037db6 | 8801a0da-5eda-49b0-b165-5abb6a25a01e | 2023-01-18 | Warnings | f4969ee2-edab-4366-bbe6-c9d890037db6 8801a0da-5eda-49b0-b165-5abb6a25a01e |
Adverse event summaries are temporarily unavailable. Other product information remains available.