MADE BY DENTISTS, INC. TOTAL CARE- sodium fluoride paste

Made By Dentists, Inc. Total Care by

Drug Labeling and Warnings

Made By Dentists, Inc. Total Care 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:

Sodium Fluoride 0.24%

PURPOSE

Purpose  Anticavity

INDICATIONS & USAGE

Use: Aids in the prevention of cavities.

WARNINGS

Warnings:

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 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 INGREDIENT

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

QUESTIONS

Questions?  +1 (646) 980-6461

Whitening Toothpaste Product Labeling

Total Care 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. TOTAL CARE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-018
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-018-06	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	M021	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(75065-018)