MADE BY DENTISTS WHITENING- 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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Made By Dentists​™ Whitening Toothpaste

Drug Facts

Active ingredient: Sodium Fluoride 0.24%

PurposeAnticavity

Use: Aids in the prevention of cavities.

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 swall-
  owing), 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:

Questions or comments?

+1 (646) 980-6461

Product Labeling

Made By Dentists​™

Whitening

Toothpaste

Fresh Mint Flavor

Fluoride Anticavity Toothpaste

NET WT 4.2 Oz / 120 g

MADE IN THE USA

90 South Dale, Suite 8, Saint Paul,

Minnesota, USA 55102

Carton

Whitng 015 Crtn

Tube

Whitng 015 Tube

res

MADE BY DENTISTS WHITENING 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-015
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 (UNII: 5HK03SA80J)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75065-015-061 in 1 CARTON07/15/2022
1120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/15/2022
Labeler - Oral Spotlight Care Inc (117405870)
Registrant - Oral Spotlight Care Inc (117405870)

Revised: 7/2022
Document Id: b1a56a39-231e-4fe5-890a-b99950550f10
Set id: a4f68d70-4a4f-4414-bf27-6a2a3da6bd21
Version: 2
Effective Time: 20220722
 
Oral Spotlight Care Inc