SPOTLIGHT PREGNANCY- sodium fluoride paste

Spotlight Pregnancy by

Drug Labeling and Warnings

Spotlight Pregnancy 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:
older: Brush teeth vithouroughly, 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, Pentasodium

Triphosphate, Sodium Bicarbonate, Cocamidopropyl Betaine,

Cellulose Gum, Titanium Dioxide, Flavor, Cyanocobalamin,

Folic Acid, Calcium Gluconate, Sodium Saccharin

QUESTIONS

Questions?  +1 (646) 9806461

PRINCIPAL DISPLAY PANEL

Spotlight

Oral Care

CREATED BY DENTISTS

 Pregnancy

Toothpaste

Mild Mint Flavor

Contains

Fluoride | Calcium Gluconate

Cyanocobalamin | Folic Acid

Fluoride Anticavity

Pregnancy Toothpaste

NET WT 3.5oz (100g)

MADE IN THE USA

Spotlight Oral Care, 90 South Dale, Suite #8

Saint Paul, Minnesota, USA 55102

res

INGREDIENTS AND APPEARANCE

SPOTLIGHT PREGNANCY 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-004
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)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CYANOCOBALAMIN (UNII: P6YC3EG204)
FOLIC ACID (UNII: 935E97BOY8)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-004-01	100 g in 1 TUBE; Type 0: Not a Combination Product	03/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/12/2021	12/31/2023

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)