SPOTLIGHT ORAL CARE FOR GUM HEALTH- sodium fluoride paste

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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient  Sodium Fluoride 0.24%

PURPOSE

Purpose  Anticavity

INDICATIONS & USAGE

Use  aids in the prevention of dental decay.

WARNINGS

Warnings

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 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 INGREDIENT

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

QUESTIONS

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

Tube

res

INGREDIENTS AND APPEARANCE

SPOTLIGHT ORAL CARE FOR GUM HEALTH 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-006
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-006-02	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 final	part355	06/11/2021	12/31/2023

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)