Eurofresh Whitening

Eurofresh Whitening is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Farmasi US LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 74690-008, application M021, label effective 20231105. It is one of 118 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, whiten teeth. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USE Helps protect against cavities Helps whiten teeth

DIRECTION Supervise children as necessary until capable of using without supervision. Do not swallow. Rinse away toothpaste residue thoroughly after brushing. Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Children under 6 years: instruct in good brushing and rinsing habits (to minimize swallowing). Children under 2 years: ask a dentist or physician.

WARNINGS Do not use if irritation occurs and persists. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 118 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 Eurofresh Whitening used for?
USE Helps protect against cavities Helps whiten teeth

Who makes Eurofresh Whitening?
Farmasi US LLC is the labeler of record for Eurofresh Whitening. 118 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 Eurofresh Whitening 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 Eurofresh Whitening 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. 118 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 Eurofresh Whitening 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.