CrystLCare Regeneration Plus

CrystLCare Regeneration Plus is an FDA-registered drug product whose active ingredient is POTASSIUM NITRATE, SODIUM FLUORIDE. It is labelled by GreenMark Biomedical Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 87587-250, application M022, label effective 20260914. It is one of 5 FDA drug label records sharing the active ingredient POTASSIUM NITRATE, 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 POTASSIUM NITRATE, SODIUM FLUORIDE are most often described in connection with: prevention dental, caries cavities, builds protection, against painful, teeth cold, heat acids, sweets contact. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES Aids in the prevention of dental caries (cavities) Builds protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

DIRECTIONS adults and children 6 years of age and older: Use once a day after brushing teeth with toothpaste followed by rinsing with water. Apply dental strip onto the teeth. Allow to remain on the teeth for 3 min and then spit out residue. Do not eat or drink for 30 minutes. Instruct children under 12 years of age in the use of this product. Supervise children as necessary until capable of using without supervision. children under the age of 6: Consult a dentist.

WARNINGS For topical intraoral use only. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product for more than 4 weeks unless recommended by a dentist or doctor.

FDA lists 5 drug label records with POTASSIUM NITRATE, 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 CrystLCare Regeneration Plus used for?
USES Aids in the prevention of dental caries (cavities) Builds protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Who makes CrystLCare Regeneration Plus?
GreenMark Biomedical Inc. is the labeler of record for CrystLCare Regeneration Plus. 5 FDA label records share the active ingredient POTASSIUM NITRATE, 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 CrystLCare Regeneration Plus 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 CrystLCare Regeneration Plus 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 POTASSIUM NITRATE, SODIUM FLUORIDE?
Yes. 5 FDA drug label records list POTASSIUM NITRATE, 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 CrystLCare Regeneration Plus 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.