FluoriMax 5000 Sensitive
FluoriMax 5000 Sensitive is an FDA drug label for the active ingredient 1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE manufactured by Elevate Oral Care administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20200831.
- Generic name
- 1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE
- Manufacturer
- Elevate Oral Care
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 57511-0503
- Application
- N/A
- Label effective
- 20200831
About this product
FluoriMax 5000 Sensitive is an FDA-registered drug product whose active ingredient is 1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE. It is labelled by Elevate Oral Care taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 57511-0503, label effective 20200831. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
Warnings
Warnings Section Do not swallow. Keep out of reach of children under 12 years of age. Read all the instructions and prescribing information before using this product. Do not freeze or expose to extreme heat
Recall and safety notices
2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0627-2026 | Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. | Elevate Oral Care | Class II | Ongoing | 20260701 |
| D-0658-2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1 | Elevate Oral Care | Class III | Terminated | 20240918 |
Frequently asked questions
What is FluoriMax 5000 Sensitive used for?
No indications section is present in the FDA label on file for this product. Consult the prescribing information supplied with the medicine or ask a pharmacist.
Who makes FluoriMax 5000 Sensitive?
Elevate Oral Care is the labeler of record for FluoriMax 5000 Sensitive.
What form does FluoriMax 5000 Sensitive come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is FluoriMax 5000 Sensitive prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has FluoriMax 5000 Sensitive been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.