SPL UNCLASSIFIED SECTION
Drug Facts
Drug Facts
Active ingredient Sodium Fluoride 0.05%
Purpose Anticavity
Use aids in the prevention of dental cavities
Warnings
Some people may experience tooth sensitivity or gum
discomfort when using whitening products. This discomfort is
temporary and not harmful. If you experience more than mild
tooth sensitivity, stop use and consult your dentist or doctor.
Keep out of reach of children. If more than used for rinsing
is accidentally swallowed, get medical help or contact a
Poison Control Center right away.
Directions
■ adults and children 12 years of age and older:
■ use twice a day after brushing your teeth with a toothpaste
■ vigorously swish 10 milliliters (2 teaspoonfuls) of rinse between
your teeth for 1 minute and then spit out.
■ do not swallow the rinse
■ do not eat or drink for 30 minutes after rinsing
habits (to minimize swallowing).
■ supervise children as necessary until capable of using without supervision
■ children under 12 years of age: consult a dentist or doctor
Other information ■ store at room temperature
Inactive Ingredients
Glycerin, Water, Xylitol, Hydrogen Peroxide, Poloxamer 407,
Sodium Saccharin, Carrageenen, Glycolipids, Mentha
Piperita (peppermint) oil , Sodium Benzoate
Questions? +1 (646) 9806461
Spotlight
Oral Care
CREATED BY DENTISTS
W
Mouthwash
for Whitening
Teeth
Peppermint Flavor
NET WT. 16.9 fl oz (500 mL)
MADE IN THE USA
Spotlight Oral Care, 90 South Dale, Suite #8
Saint Paul, Minnesota, USA 55102
res
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 75065-001 | 75065-001-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| CARRAGEENAN | 5C69YCD2YJ | IACT |
| PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS | PB22NX2CJL | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| SODIUM BENZOATE | OJ245FE5EU | 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 |
|---|---|---|---|---|---|---|
| dc196a56-98a8-4125-966b-2c6c84011f52 | 64328e9f-ede7-42c5-a604-2983ffcd6918 | 2023-01-18 | Warnings | dc196a56-98a8-4125-966b-2c6c84011f52 64328e9f-ede7-42c5-a604-2983ffcd6918 |
Adverse event summaries are temporarily unavailable. Other product information remains available.