MADE BY DENTISTS WHITENING- sodium fluoride paste

Made By Dentists Whitening by

Drug Labeling and Warnings

Made By Dentists Whitening by is a Otc medication manufactured, distributed, or labeled by Oral Spotlight Care 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:

QUESTIONS

Questions or comments?

+1 (646) 980-6461

Product Labeling

Made By Dentists​™

Whitening

Toothpaste

Fresh Mint Flavor

Fluoride Anticavity Toothpaste

NET WT 4.2 Oz / 120 g

MADE IN THE USA

90 South Dale, Suite 8, Saint Paul,

Minnesota, USA 55102

Carton

Tube

res

INGREDIENTS AND APPEARANCE

MADE BY DENTISTS WHITENING 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-015
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)
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
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: 75065-015-06	1 in 1 CARTON	07/15/2022
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 final	part355	07/15/2022

Labeler - Oral Spotlight Care Inc (117405870)

Registrant - Oral Spotlight Care Inc (117405870)