Dentalclean Regenerator Sensitive Dental Gel with Fluoride

Dentalclean Regenerator Sensitive Dental Gel with Fluoride is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE 0.24%. It is labelled by Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 84035-002, application M021, label effective 20260831. It is one of 3 FDA drug label records sharing the active ingredient SODIUM FLUORIDE 0.24%. 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 0.24% are most often described in connection with: prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use aids in the prevention of dental cavities

Directions Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. • Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision. • Children under 2 years of age: do not use unless directed by a dentist or doctor or as directed by a dentist or doctor.

WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.

FDA lists 3 drug label records with SODIUM FLUORIDE 0.24% 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 Dentalclean Regenerator Sensitive Dental Gel with Fluoride used for?
Use aids in the prevention of dental cavities

Who makes Dentalclean Regenerator Sensitive Dental Gel with Fluoride?
Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda is the labeler of record for Dentalclean Regenerator Sensitive Dental Gel with Fluoride. 3 FDA label records share the active ingredient SODIUM FLUORIDE 0.24%, 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 Dentalclean Regenerator Sensitive Dental Gel with Fluoride 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 Dentalclean Regenerator Sensitive Dental Gel with Fluoride 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 0.24%?
Yes. 3 FDA drug label records list SODIUM FLUORIDE 0.24% 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 Dentalclean Regenerator Sensitive Dental Gel with Fluoride 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.