MADE BY DENTISTS, INC. REBUILDING- potassium nitrate, 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 Rebuilding Toothpaste

Drug Facts

Active ingredient:

Potassium Nitrate 5.0%

Sodium Fluoride 0.24%

Purpose

Potassium Nitrate ....  Desensitizer

Sodium Fluoride ....... Anticavity

Use: Aids in the prevention of cavities. Helps
Reduce painful sensitivity of teeth to cold,
heat, acids, sweets, or contact.

Warnings:

Sensitive teeth may indicate a serious problem
that may need prompt care by a dentist. See
your dentist if the problem persists or worsens.
Do not use this product longer than 4 weeks
unless recommended by a dentist or doctor.

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 12 years of age and older:
  Apply at least a 1-inch strip of the product onto a
  soft bristle toothbrush. Brush teeth thoroughly for
  at least 1 minute twice a day, (morning and evening)
  or as recommended by a dentist or doctor.
• Make sure to brush all sensitive areas of the teeth.
• Children under 12 years of age: Consult a dentist
  or doctor.

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

Questions?  +1 (646) 980-6461

Rebuilding Toothpaste Product Labeling

Rebuilding Toothpaste

Made By Dentists ​™

Fresh Mint Flavor

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

Rebuilding carton-019

Tube

Rebuilding  tube-019

res

MADE BY DENTISTS, INC. REBUILDING 
potassium nitrate, sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-019
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75065-019-061 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 not finalpart35601/24/2023
Labeler - Made By Dentists, Inc. (117405870)
Registrant - Made By Dentists, Inc. (117405870)

Revised: 1/2023
Document Id: f3834bf9-126a-5d0d-e053-2995a90a9f93
Set id: d85f52ca-6339-4ec2-a910-61ddca91a21d
Version: 2
Effective Time: 20230130
 
Made By Dentists, Inc.