Spotlight Oral Care Toothpaste for Gum Health

Spotlight Oral Care for Gum Health by

Drug Labeling and Warnings

Spotlight Oral Care for Gum Health 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 GUM HEALTH- 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 Gum Health

Drug Facts

Active ingredient  Sodium Fluoride 0.24%

Purpose  Anticavity

Use  aids in the prevention of dental decay.

Warnings

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: Brush teeth thoroughly, preferably after each meal or
at least twice a day, or as directed by a dentist or doctor.
Instruct children under 6 years of age in good brushing
and rinsing habits (to minimize swallowing), and only use a
pea size amount Supervise children as necessary until
capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients
Sorbitol, Water (purified), Hydrated Silica, Glycerin,
Sodium Bicarbonate, Pentasodium Triphosphate,
Cocamidopropyl Betaine, Cellulose Gum, Titanium Dioxide,
Zinc Lactete, Flavor

Questions?  +1 (646) 9806461

Product Labeling

Spotlight

Oral Care

CREATED BY DENTISTS

G

Toothpaste

for Gum

Health

_______ Active Ingredient _________

              Sodium Fluoride

___________________________

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

006 Cartn

Tube

006 Tube

res

SPOTLIGHT ORAL CARE FOR GUM HEALTH 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75065-006
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ZINC LACTATE (UNII: 2GXR25858Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-006-021 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 finalpart35506/11/202112/31/2023
Labeler - Oral Spotlight Care Inc (117405870)
Registrant - Oral Spotlight Care Inc (117405870)

Revised: 1/2023