MADE BY DENTISTS, INC. REBUILDING- potassium nitrate, sodium fluoride paste

Made By Dentists, Inc. Rebuilding by

Drug Labeling and Warnings

Made By Dentists, Inc. Rebuilding by is a Otc medication manufactured, distributed, or labeled by Made By Dentists, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient:

Potassium Nitrate 5.0%

Sodium Fluoride 0.24%

PURPOSE

Purpose

Potassium Nitrate ....  Desensitizer

Sodium Fluoride ....... Anticavity

INDICATIONS & USAGE

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

WARNINGS

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

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

Tube

res

INGREDIENTS AND APPEARANCE

MADE BY DENTISTS, INC. REBUILDING 
potassium nitrate, sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-019
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-019-06	1 in 1 CARTON	01/24/2023	12/31/2025
1		120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/24/2023	12/31/2025

Labeler - Made By Dentists, Inc. (117405870)

Registrant - Made By Dentists, Inc. (117405870)

Establishment
Name	Address	ID/FEI	Business Operations
Massco Dental		008081858	manufacture(75065-019)