SPL UNCLASSIFIED SECTION
Kit contains:
Anticavity Toothpaste for Bad Breath
Foaming Anticavity Mouthwash for Bad Breath
Mouth Spray for Bad Breath
Spotlight Oral Care Kit for Bad Breath
- Manufacturer
- Oral Spotlight Care Inc
- Effective date
- 2023-01-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:39:58
Label at a glance#
ProductSpotlight Oral Care Kit for Bad Breath
Active ingredientSODIUM FLUORIDE
Label structure11 sections
Label contents#
Full prescribing information#
Drug Facts
Active ingredient (Anticavuty Toothpaste only)
Sodium Fluoride 0.24% (0.10% W/V fluoride ion)
Active ingredient (Foaming Anticavity Mouthwash for Bad Breath only)
Sodium Fluoride 0.05% (0.02% W/V fluoride ion)
OTC - PURPOSE SECTION
Purpose Anticavity
INDICATIONS & USAGE SECTION
Use Aids in the prevention of dental decay.
WARNINGS SECTION
Warnings
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If more than used for
brushing is accidentally swallowed, get medical help or
contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions (Anticavuty Toothpaste only)
Adults and children 2 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 doctor. |
Children under 6 years of age | Instruct in good brushing and rinsing habits (to minimize swallowing), Supervise children as necessary until |
Children under 2 years of age | Consult a dentist or doctor. |
Directions (Foaming Anticavity Mouthwash for Bad Breath only)
Adults and children 6 years of age and older | Use once a day after brushing your swish 10 milliliters 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. |
Children under 12 years of age | Instruct in good brushing and rinsing habits (to minimize swallowing), Supervise children as necessary until |
| Children under 6 years of age | Consult a dentist or doctor. |
OTHER SAFETY INFORMATION
Other Information
Do not use if outer container is open or if sticker seal on
the lid is missing or broken.
INACTIVE INGREDIENT SECTION
Inactive Ingredients (Anticavity Toothpaste only)
Sorbitol, Water (purified), Hydrated Silica, Glycerin,
Sodium Bicarbonate, Pentasodium Triphosphate,
Cocamidopropyl Betaine, Cellulose Gum, Titanium Dioxide,
Zinc Lactete, Flavor
Inactive Ingredients (Foaming Anticavity Mouthwash for Bad Breath only)
Water (purified), Xylitol, Poloxamer 407, Cocamidopropyl
Betaine, Chinese Mint (Mentha Arvensis) Oil, Sodium
Saccharin, Tocopherol, Zinc Citrate, Sodium Chloride,
Benzoic Acid, Benzyl Alcohol
OTC - QUESTIONS SECTION
Questions? +1 (646) 9806461
Kit for Bad Breath Labeling
Spotlight Oral Care
B
Kit for Bad Breath
Contains
Sodium Fluoride
Fluoride AnticavityToothpaste NetWt. 3.5 oz (100 g) +
Auoride Anticavity Foaming Mouthwash for Bad Breath1fl oz (30 ml)+
Mouth Sprayfor Bad Breath 0.7ft oz (20 ml)
MADE IN THE USA
Distributed by Spotlight Oral Care INC,
90 South Dale, Suite #8, Saint Paul, Minnesota, USA 55102
res
Products#
Every source-derived product name is available through these pages.
- Spotlight Oral Care Kit for Bad Breath
- Kit for Bad Breath
- Spotlight Oral Care for Gum Health
- SODIUM FLUORIDE
- FLUORIDE ION
- SORBITOL
- WATER
- HYDRATED SILICA
- GLYCERIN
- SODIUM BICARBONATE
- SODIUM TRIPOLYPHOSPHATE ANHYDROUS
- COCAMIDOPROPYL BETAINE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- TITANIUM DIOXIDE
- ZINC LACTATE
- Anticavity Fluoride Foaming Mouthwash for Bad Breath
- XYLITOL
- POLOXAMER 407
- MENTHA ARVENSIS LEAF OIL
- SACCHARIN SODIUM
- TOCOPHEROL
- ZINC CITRATE
- SODIUM CHLORIDE
- BENZOIC ACID
- BENZYL ALCOHOL
- Mouth Spray for Bad Breath
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75065-010 | 75065-010-05 |
| 75065-006 | 75065-006-02 |
| 75065-012 | 75065-012-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| dce522a8-0477-44f2-bc99-908b4b20c74a | 58905f30-a13a-4ba5-90fa-62e50af766f2 | 2023-01-18 | Warnings | dce522a8-0477-44f2-bc99-908b4b20c74a 58905f30-a13a-4ba5-90fa-62e50af766f2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.