Spotlight Oral Care Toothpaste for Rebuilding Teeth

Spotlight Oral Care for Rebuilding Teeth by

Drug Labeling and Warnings

Spotlight Oral Care for Rebuilding Teeth by is a Otc medication manufactured, distributed, or labeled by Oral Spotlight Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPOTLIGHT ORAL CARE FOR REBUILDING TEETH- potassium nitrate, sodium fluoride paste 
Oral Spotlight Care Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Spotlight Oral Care Toothpaste for Rebuilding Teeth

Drug Facts

Active ingredient

Potassium nitrate 5.0%

Sodium fluoride 0.24%

Purpose  

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

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

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

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.

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.

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

Questions?  +1 (646) 9806461

Product Labeling

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

008 Cartn

Tube

008 Tube

res

SPOTLIGHT ORAL CARE FOR REBUILDING TEETH 
potassium nitrate, sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75065-008
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5.0 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-008-021 in 1 CARTON06/11/2021
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/11/202112/31/2023
Labeler - Oral Spotlight Care Inc (117405870)
Registrant - Oral Spotlight Care Inc (117405870)

Revised: 1/2023