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.

----------

Just Right 5000 Spearmint

Warnings

Do not swallow. Keep out of reach of childern under 6 years of age. Read all instructions and prescribing information before using this product.

Package label and instruction for use

Primary label

JUST RIGHT 5000 
1.1% sodium fluoride toothpaste gel, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57511-0003
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
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorgreenScore    
ShapeROUNDSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57511-0003-197 g in 1 TUBE; Type 0: Not a Combination Product08/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/28/2020
Labeler - Elevate Oral Care (002863526)
Registrant - Elevate Oral Care (002863526)
Establishment
NameAddressID/FEIBusiness Operations
Elevate Oral Care002863526manufacture(57511-0003)

Revised: 2/2021
Document Id: bad81d85-b4fb-324b-e053-2a95a90aac73
Set id: adf22ce4-b567-5274-e053-2a95a90a8536
Version: 2
Effective Time: 20210208
 
Elevate Oral Care