Pearl White

Pearl White is an FDA-registered drug product whose active ingredient is POTASSIUM NITRATE, SODIUM FLUORIDE. It is labelled by Beyond International Inc. taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 42199-006, application M022, label effective 20231128. 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: helps reduce, painful sensitivity, teeth cold, heat acids, sweets contact, prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities.

Directions Adults and Children 12 years of age and older Apply at least a 1-inch strip of toothpaste onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as directed by a dentist or doctor. Do not swallow. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor.

Warnings

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 Pearl White used for?
Uses Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities.

Who makes Pearl White?
Beyond International Inc. is the labeler of record for Pearl White. 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 Pearl White 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 Pearl White 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 Pearl White 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.