botalab HERBAL COMPLETE TOOTH

botalab HERBAL COMPLETE TOOTH is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by KMPHARMACEUTICAL CO., LTD. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 50555-201, application M021, label effective 20260507. 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: helps prevent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use(s) ■ Helps prevent cavities

Directions ■ Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. ■ Children 2 to 6 years: Use only a pea-sized amount and supervise brushing to minimize swallowing. ■ Children under 2 years: Ask a dentist or physician.

Warnings ■ 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. ■ If irritation of the mouth or gums occurs, discontinue use and consult a dentist or physician.

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 botalab HERBAL COMPLETE TOOTH used for?
Use(s) ■ Helps prevent cavities

Who makes botalab HERBAL COMPLETE TOOTH?
KMPHARMACEUTICAL CO., LTD. is the labeler of record for botalab HERBAL COMPLETE TOOTH. 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 botalab HERBAL COMPLETE TOOTH come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is botalab HERBAL COMPLETE TOOTH 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. 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 botalab HERBAL COMPLETE TOOTH 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.