Stance
Stance 0.63% Stannous Fluoride Concentrate Rinse Tropical Breeze
Approved
Approval ID
3ae8badf-f960-62fd-e054-00144ff8d46c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 23, 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 Code57511-0202
Application NumberM021
Product Classification
M
Marketing Category
C200263
G
Generic Name
0.63% Stannous Fluoride Concentrate Rinse
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 23, 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: 2/3/2015
Primary PACKAGE LABEL.
PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 9/23/2025
Uses
Indications
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 2/3/2015
Active Ingredients
WARNINGS SECTION
LOINC: 34071-1Updated: 9/23/2025
Warnings
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 9/23/2025
Keep Out of Reach of Children
INSTRUCTIONS FOR USE SECTION
LOINC: 59845-8Updated: 9/23/2025
Directions
Instructions for Use
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 9/23/2025
Inactive Ingredients
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 9/23/2025
Questions
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 1/31/2018
Dosage and Administration
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 1/31/2018
Purpose
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 9/23/2025
Other Information
