Spotlight Oral Care Fluoride Anticavity Pregnancy Toothpaste

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]

SPOTLIGHT PREGNANCY- 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 Fluoride Anticavity Pregnancy Toothpaste

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:
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 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?  +1 (646) 9806461

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

Preg TPaste

res

SPOTLIGHT PREGNANCY 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75065-004
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)  
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-004-01100 g in 1 TUBE; Type 0: Not a Combination Product03/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/12/202112/31/2023
Labeler - Oral Spotlight Care Inc (117405870)
Registrant - Oral Spotlight Care Inc (117405870)

Revised: 1/2023
Document Id: a5c32136-2d8d-4bd0-b01b-ef0048fd5234
Set id: 2ff05a69-5d47-4f34-b6a1-9a9fe35f43bb
Version: 2
Effective Time: 20230118