MADE BY DENTISTS, INC. REBUILDING- potassium nitrate, sodium fluoride paste 
Made By Dentists, Inc.

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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 CARTON01/24/202312/31/2025
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 DrugM02201/24/202312/31/2025
Labeler - Made By Dentists, Inc. (117405870)
Registrant - Made By Dentists, Inc. (117405870)
Establishment
NameAddressID/FEIBusiness Operations
Massco Dental008081858manufacture(75065-019)

Revised: 12/2024
Document Id: 2a7f8a3c-f8d9-1f80-e063-6394a90a9056
Set id: d85f52ca-6339-4ec2-a910-61ddca91a21d
Version: 4
Effective Time: 20241230
 
Made By Dentists, Inc.