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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Just Right 5000- Bubble Mint with Xylitol

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

Primary Package Label

JUST RIGHT 5000 
1.1% sodium fluoride toothpaste gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57511-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g  in 100 g
Product Characteristics
ColorblueScore    
ShapeROUNDSize
FlavorBUBBLE GUM (And Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0001-197 g in 1 TUBE; Type 0: Not a Combination Product08/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/05/2020
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526manufacture(57511-0001)

Revised: 10/2022
Document Id: ec56455c-d616-93aa-e053-2a95a90a6dbc
Set id: ac24342d-382e-6fc2-e053-2a95a90acd69
Version: 3
Effective Time: 20221031
 
Elevate Oral Care