Spotlight Oral Care for Rebuilding Teeth

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 21:40:00

Label at a glance#

ProductSpotlight Oral Care for Rebuilding Teeth
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Potassium nitrate 5.0%

Sodium fluoride 0.24%

OTC - PURPOSE SECTION

Purpose  

Potassioum nitrate .......... Desinsitizer

Sodium fluoride ............... Anticavity

INDICATIONS & USAGE SECTION

Use • Aids in the prevention of dental decay.
• Helps reduce painful sensitivity of the teeth to cold,
heat, acids, sweets, or contact.

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

Inactive Ingredients
Sorbitol, Hydrated Silica, Water (purified), Glycerin,
Calcium Carbonate, Sodium Bicarbonate,
Cocamidopropyl Betaine, Flavor, Cellulose Gum, Sodium
Saccharin, Tricalcium Phosphate, Titanium Dioxide

OTC - QUESTIONS SECTION

Questions?  +1 (646) 9806461

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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Tube

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-00875065-008-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4969ee2-edab-4366-bbe6-c9d890037db68801a0da-5eda-49b0-b165-5abb6a25a01e2023-01-18WarningsExact identifier
spl id: f4969ee2-edab-4366-bbe6-c9d890037db6
spl set id: 8801a0da-5eda-49b0-b165-5abb6a25a01e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.