ZOOBY Gator Gum

ZOOBY Gator Gum is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Young Dental Manufacturing Co 1, LLC taken by dental and marketed as a human prescription drug product. Identifiers on file: NDC 0273-0370, label effective 20230103. 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 aid, protection against, dental caries, optimized low. 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 to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.

Dosage and Administration 1. Break protective tab adjacent to trigger. 2. Shake can thoroughly for at least 15 seconds before each use. 3. Hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (The foam will expand slightly higher than the fluoride tray.) 4. Dry tooth surfaces prior to inserting tray(s) in mouth. 5. Insert tray(s) into patient’s mouth and have them bite down for 1-4 minutes. 6. Remove tray(s) and have patient expectorate. 7. Advise the patient not to eat, drink or rinse for 30 minutes after the treatment.

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 ZOOBY Gator Gum used for?
Indications For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.

Who makes ZOOBY Gator Gum?
Young Dental Manufacturing Co 1, LLC is the labeler of record for ZOOBY Gator Gum. 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 ZOOBY Gator Gum 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 ZOOBY Gator Gum 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 ZOOBY Gator Gum 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.