SPL UNCLASSIFIED SECTION
Drug Facts
Drug Facts
Sodium Fluoride 0.05% (.02% w/v fluoride ion)
Purpose Anticavity
Use aids in the prevention of dental cavities.
Warnings
Keep out of reach of children.
If more than used is accidentally swallowed, get
medical help or contact a Poison Control Center right away.
Directions
• Adults and children 6 years of age and older:
• Use once 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.
• Instruct children under 12 years of age in good rinsing
habits (to minimize swallowing).
• Supervise children as necessary until capable of using
without supervision
• Children under 6 years of age: Consult a dentist or doctor
Other information • Store at room temperature.
Inactive ingredients
Deionized Waler, Glycerin, Xylital, Sorbitol, Poloxamer 407,
Glycolipid, Mentha Arvensis (peppemint) Oil, Xanthan Gum,
Potassium Sorbate, Carrageenan, Sodium Benzoate, Sodium
Saccharin, Carthamus Tinctorius, Allantoin, Beta Vulgaris,
Spirulina Maxima
Questions? +1 (646) 9806461
Spotlight®
Oral Care
CREATED BY DENTISTS
G
Mouthwash
for Gum Health
Aids in Relieving Symptoms
of Bad Breath, Inflamed
& Bleeding Gums
-- Active Ingredient --
Sodium Fluoride
--- Alcohol Free --
Anticavity Fuoride Mouthwash
Peppermint Flavor
IMPORTANT: Read directions for proper use.
NET WT. 16.9 fl oz (500mL)
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 |
|---|---|
| 75065-002 | 75065-002-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| XYLITOL | VCQ006KQ1E | IACT |
| SORBITOL | 506T60A25R | IACT |
| POLOXAMER 407 | TUF2IVW3M2 | IACT |
| PSEUDOMONAS GLUCOSE FERMENTATION RHAMNOLIPIDS | PB22NX2CJL | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| POTASSIUM SORBATE | 1VPU26JZZ4 | IACT |
| CARRAGEENAN | 5C69YCD2YJ | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SAFFLOWER | 4VBL71TY4Y | IACT |
| ALLANTOIN | 344S277G0Z | IACT |
| BETA VULGARIS | 4G174V5051 | IACT |
| SPIRULINA MAXIMA | 9K7IG15M0Q | 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 |
|---|---|---|---|---|---|---|
| b7d9ebe5-beef-4753-97ba-082c95998766 | 04fab543-e6dd-4f34-9f22-e39e86abb6bd | 2023-11-19 | Warnings | b7d9ebe5-beef-4753-97ba-082c95998766 04fab543-e6dd-4f34-9f22-e39e86abb6bd |
Adverse event summaries are temporarily unavailable. Other product information remains available.