MADE BY DENTISTS ENAMEL REBUILDING FRESH MINT- potassium nitrate, sodium fluoride paste 
MADE BY DENTISTS INC

----------

Made by Dentists Enamel Rebuilding Toothpaste Fresh Mint

Drug Facts

Active ingredient:

Potassium Nitrate 5.0%

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Antisensitivity

Anticavity 

Use:

Aids in the prevention of cavities. Helps reduce painful sensitivity of the 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 accidentlly swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Inactive ingredients:

Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite, Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol

Questions or comments?

+ 1 (646) 980-6461

Label

Labell.jpgLabel2.jpg

MADE BY DENTISTS ENAMEL REBUILDING FRESH MINT 
potassium nitrate, sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-028
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75065-028-061 in 1 CARTON02/22/2024
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 DrugM02202/22/2024
Labeler - MADE BY DENTISTS INC (117405870)

Revised: 2/2024
Document Id: 125c3996-3210-eddf-e063-6294a90aabff
Set id: a9260baf-46c8-40cb-a6c3-7aedb086c870
Version: 1
Effective Time: 20240227
 
MADE BY DENTISTS INC