KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT

KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by DMG AMERICA, LLC taken by dental and marketed as a human prescription drug product. Identifiers on file: NDC 25047-765, label effective 20211001. 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: topical application, fluoride neutral, base aid, protection against, dental caries, extensive esthetic, intolerance acidic, fluorides kolorz. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz ® Neutral Foam requires a 4-minute application. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information. Figure

WARNING Avoid spraying toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 55-80° F. Keep from freezing.

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 KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT used for?
INDICATIONS For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz ® Neutral Foam requires a 4-minute application. Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for …

Who makes KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT?
DMG AMERICA, LLC is the labeler of record for KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE 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 KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE 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 KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE MINT 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.

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 KOLORZ NEUTRAL FLUORIDE FOAM TRIPLE 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.