Cavity Protection Fresh Mint

Cavity Protection Fresh Mint is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Oxyfresh Worldwide Inc taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 63615-000, application M021, label effective 20231025. It is one of 263 FDA drug label records sharing the active ingredient SODIUM FLUORIDE. 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.

Across FDA labelling, products containing SODIUM FLUORIDE are most often described in connection with: helps protect, against cavities. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Helps protect against cavities.

Directions Apply a pearl-size drop onto a toothbrush. Gently brush teeth in a circular motion for 2-3 minutes after each meal.

Warnings For topical application only. Do not swallow. Keep out of reach of children under six years of age. Not to be used by children under six, unless recommended by a dentist or physician. If paste is accidentally swallowed, contact a physician or Poison Control Center right away. Do not use if safety seal is torn or missing.

FDA lists 263 drug label records with SODIUM FLUORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Cavity Protection Fresh Mint used for?
Uses Helps protect against cavities.

Who makes Cavity Protection Fresh Mint?
Oxyfresh Worldwide Inc is the labeler of record for Cavity Protection Fresh Mint. 263 FDA label records share the active ingredient SODIUM FLUORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Cavity Protection Fresh Mint come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Cavity Protection Fresh Mint prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SODIUM FLUORIDE?
Yes. 263 FDA drug label records list SODIUM FLUORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Cavity Protection Fresh Mint been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.