SPL UNCLASSIFIED SECTION
Drug Facts
Mouthwash for Total Care
- Manufacturer
- Oral Spotlight Care Inc
- Effective date
- 2023-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:39:55
Label at a glance#
ProductMouthwash for Total Care
Active ingredientSODIUM FLUORIDE
Label structure10 sections
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Sodium Fluoride 0.045% (.02% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose Anticavity
INDICATIONS & USAGE SECTION
Use aids in the prevention of dental cavities.
WARNINGS SECTION
Warnings
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If more than used is accidentally swallowed, get
medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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 SAFETY INFORMATION
Other information • Store at room temperature.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Deionized Water, Glycerin, Xylitol, Xanthan Gum, Mentha
Arvensis (peppermint) Oil, Sodium Benzoate, Sodium
Saccharin, Monosodium Phosphate, Phosphoric Acid.
OTC - QUESTIONS SECTION
Questions? +1 (646) 9806461
Product Label
Spotlight®
Oral Care
CREATED BY DENTISTS
T
Mouthwash
for Total Care
Aids in Cavity Protection,
& Remineralization
-- 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
Products#
Every source-derived product name is available through these pages.
- Mouthwash for Total Care
- SODIUM FLUORIDE
- FLUORIDE ION
- WATER
- GLYCERIN
- XYLITOL
- XANTHAN GUM
- PEPPERMINT OIL
- SODIUM BENZOATE
- SACCHARIN SODIUM
- SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
- PHOSPHORIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75065-003 | 75065-003-01 |
Ingredients#
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 |
| XANTHAN GUM | TTV12P4NEE | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM | 3980JIH2SW | IACT |
| PHOSPHORIC ACID | E4GA8884NN | IACT |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 199b3979-d6ab-42ea-bdfe-ceda955af783 | 12bfd758-ec50-408d-a470-45a23ba396e4 | 2023-01-18 | Warnings | 199b3979-d6ab-42ea-bdfe-ceda955af783 12bfd758-ec50-408d-a470-45a23ba396e4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.