Stance
Stance 0.63% Stannous Fluoride Concentrate Rinse Mint
Approved
Approval ID
3ae71258-a8c2-6eb5-e054-00144ff88e88
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 22, 2025
Manufacturers
FDA
Elevate Oral Care
DUNS: 002863526
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
0.63% Stannous Fluoride Concentrate Rinse
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code57511-0201
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
0.63% Stannous Fluoride Concentrate Rinse
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 22, 2025
FDA Product Classification
INGREDIENTS (3)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 1.2 mg in 1 mL
Code: 3FTR44B32Q
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/2/2015
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 2/3/2015
Uses
INDICATIONS & USAGE SECTION
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 2/3/2015
ACTIVE INGREDIENT
WARNINGS SECTION
LOINC: 34071-1Updated: 2/3/2015
WARNINGS
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 2/3/2015
Keep Out of Reach of Children
INSTRUCTIONS FOR USE SECTION
LOINC: 59845-8Updated: 2/3/2015
Directions
INSTRUCTIONS FOR USE SECTION
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 2/3/2015
Inactive Ingredients
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 2/3/2015
Questions?
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 1/31/2018
Dosage and Administration
make 2 complete pump depressions into cup
provided (1/8 oz)
• add tap water to line (1 oz) on cup
• close cap and shake to mix
• vigorously swish 1/2 oz for one minute then
spit out and repeat with second 1/2 oz
• do not swallow the rinse
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 1/31/2018
Purpose
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 9/22/2025
Other Information
