SPOTLIGHT ORAL CARE FOR SENSITIVE TEETH- potassium nitrate, sodium fluoride paste

Spotlight Oral Care for Sensitive Teeth by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5.0%

Sodium fluoride 0.24%

PURPOSE

Purpose

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

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

INDICATIONS & USAGE

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

WARNINGS

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

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

Directions

Adults and children 12 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 12 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive ingredients
Sorbitol, Water (purified), Hydrated Silica, Glycerin,
Tricalcium Phosphate, Flavor, Xanthan Gum,
Cocamidopropyl Betaine, Sodium Saccharin,
Sodium Benzoate, Titanium Dioxide

QUESTIONS

Questions?  +1 (646) 9806461

Product Labeling

Spotlight

Oral Care

CREATED BY DENTISTS

S

Toothpaste

for Sensitive

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

Tube

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INGREDIENTS AND APPEARANCE

SPOTLIGHT ORAL CARE FOR SENSITIVE TEETH 
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-009
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5.0 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-009-02	1 in 1 CARTON	06/11/2021
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/11/2021

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)