JUST RIGHT 5000- 1.1% sodium fluoride toothpaste gel, dentifrice

Just Right 5000 by

Drug Labeling and Warnings

Just Right 5000 by is a Prescription medication manufactured, distributed, or labeled by Elevate Oral Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

Do not swallow. Keep out of reach of children under 6 years of age. Read all instructions and prescribing information before useing this product. Do not freeze or expose to extreme heat.

Pakage label and instruction for use

INGREDIENTS AND APPEARANCE

JUST RIGHT 5000 
1.1% sodium fluoride toothpaste gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57511-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g  in 100 g

Product Characteristics
Color	blue	Score
Shape	ROUND	Size
Flavor	BUBBLE GUM (And Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57511-0001-1	97 g in 1 TUBE; Type 0: Not a Combination Product	08/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/05/2020

Labeler - Elevate Oral Care (002863526)

Registrant - Elevate Oral Care (002863526)

Establishment
Name	Address	ID/FEI	Business Operations
Elevate Oral Care		002863526	manufacture(57511-0001)