Checked
OTC
Stance
0.63% stannous fluoride concentrate rinse · Stance is an over-the-counter drug containing 0.63% stannous fluoride concentrate rinse, made by Elevate Oral Care.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
INDICATIONS & USAGE SECTION Uses
Drug facts
- Generic name
- 0.63% stannous fluoride concentrate rinse
- Active ingredients
- Stannous Fluoride
- Dosage forms
- Rinse
- Label holder
- Elevate Oral Care
- FDA application
- M021
- Label updated
- 03/11/2026
Active ingredients
Active Ingredients
Purpose
Purpose
Uses
INDICATIONS & USAGE SECTION Uses
Directions
Dosage and Administration
Warnings
Warnings
Keep out of reach of children
Keep Out of Reach of Children
Inactive ingredients
Inactive Ingredients
Questions?
Questions
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Rinse | 1.2 mg/mL | topical | 2 |
Manufacturers and labels
2 FDA labels
- Elevate Oral CareShown hereM021 · Label 03/11/2026 · NDC 57511-0201Full label
- Elevate Oral CareM021 · Label 03/11/2026 · NDC 57511-0202Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing11/20/2024Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g)...Keystone Industries · Subpotent Drug
- Class IIDrug01/03/2024Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by...CARDINAL HEALTHCARE · CGMP Deviations: Products were exposed to temperatures outside of...
- Class IIDrug12/06/2017Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide...EAI-JR286 INC · CGMP Deviations: products manufactured in a manner that may impact...
- Class IIDrug07/12/2017parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454%...GSK Consumer Healthcare · Presence of Foreign Substance: possibility of the presence of...
- Class IIDrug04/05/2017Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v fluoride ion)), Net Wt. 3.4 oz...GSK Consumer Healthcare · Presence of Foreign Substance; low concentration of an additional...
Stance: common questions
- What is Stance used for?
- INDICATIONS & USAGE SECTION Uses
- Is Stance a prescription drug?
- No. Stance is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Stance?
- Yes. Other FDA-listed products with the same active ingredients include Gum Detoxify, Colgate Total SF Whitening, Home Care Fluoride, Ionite H.
- Who makes Stance?
- Elevate Oral Care lists Stance with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 03/11/2026 · Label text is shown as published by the manufacturer. Not medical advice