Ionite R

Ionite R is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Dharma Research, Inc. taken by dental and marketed as a human prescription drug product. Identifiers on file: NDC 53045-265, label effective 20201106. 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: instruct patient, one-minute ready-to-use, fluoride treatment, remove cap, insert enclosed, tighten pump, thoroughly rinse, entire amount. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat or drink for at least 30 minutes.

CONTRAINDICATIONS Avoid use in patients with known hypersensitivity to fluoride

ADVERSE REACTIONS To report suspected adverse reactions, contact Dharma Research, Inc. at 1-877-833-3725 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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 Ionite R used for?
INDICATIONS AND USAGE This is a one-minute, ready-to-use fluoride treatment rinse for in-office patient use. Remove cap from bottle and insert enclosed pump into bottle and tighten. Pump ½ oz into a cup. Instruct patient to thoroughly rinse the entire amount around and between teeth for one minute, then spit-out rinse. Repeat the procedure to ensure maximum benefit. Instruct patient not to eat …

Who makes Ionite R?
Dharma Research, Inc. is the labeler of record for Ionite R. 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 Ionite R 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 Ionite R 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 Ionite R 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.