MADE BY DENTISTS, INC. WHITENING- sodium fluoride paste 
Made By Dentists, 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%

Purpose  Anticavity

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:
Sorbitol, Water, Hydrated Silica, Xylitol, Sodium
Tripolyphosphate, Flavor, Cocamidopropyl Betaine,
Cellulose Gum, Titanium Dioxide, Potassium
Sorbate, Sodium Saccharin, Citric Acid, Hydrogen
Peroxide, Sodium Bicarbonate

Questions?  +1 (646) 980-6461

Whitening Toothpaste Product Labeling

Whitening Toothpaste

Made By Dentists​™

NET WT 4.2 Oz / 120g

MADE IN THE USA

@Copyright: 2022 Made By Dentists

439 S. Cedros Avenue, Suite 402.

Solana Beach, CA, 92075

Carton

Whitening box-017

Tube

Whitening tube-017

res

MADE BY DENTISTS, INC. WHITENING 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-017
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)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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:75065-017-061 in 1 CARTON01/24/2023
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 finalpart35501/24/2023
Labeler - Made By Dentists, Inc. (117405870)
Registrant - Made By Dentists, Inc. (117405870)

Revised: 1/2023
Document Id: e739d916-df68-4ef5-bc66-e06c24f0ab86
Set id: 374fed0e-ae5d-4062-8d55-696498b60714
Version: 1
Effective Time: 20230126
 
Made By Dentists, Inc.