Sensitive Tooth Polish
Sensitive Tooth Polish is an FDA drug label for the active ingredient POTASSIUM NITRATE AND SODIUM FLUORIDE manufactured by Melaleuca, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20180329.
- Generic name
- POTASSIUM NITRATE AND SODIUM FLUORIDE
- Manufacturer
- Melaleuca, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 54473-302
- Application
- part356
- Label effective
- 20180329
About this product
Sensitive Tooth Polish is an FDA-registered drug product whose active ingredient is POTASSIUM NITRATE AND SODIUM FLUORIDE. It is labelled by Melaleuca, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 54473-302, application part356, label effective 20180329. It is one of 6 FDA drug label records sharing the active ingredient POTASSIUM NITRATE AND 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.
What it is used for
Across FDA labelling, products containing POTASSIUM NITRATE AND SODIUM FLUORIDE are most often described in connection with: regularly builds, increasing protection, against painful, teeth cold, heat acids, sweets contact, prevention cavities. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact aids in the prevention of cavities
Dosage & Administration
Directions adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years of age: consult a dentist or physician
Warnings
Warnings When using this product do not use longer than four weeks unless recommended by a dentist
More products with the same ingredient
POTASSIUM NITRATE AND SODIUM FLUORIDEOpal by Opalescence Sensitivity
View labelOpalescence Sensitivity Relief Whitening
View labelOpalescence Whitening Sensitivity Relief
View labelSensitivity and Gum with Cavity Protection
View labelUNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE
View labelHow products containing POTASSIUM NITRATE AND SODIUM FLUORIDE compare
FDA lists 6 drug label records with POTASSIUM NITRATE AND 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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Ultradent Products, Inc. | 3 |
| — | — | Health and Natural Beauty USA Corp | 1 |
| — | — | Melaleuca, Inc. | 1 |
| — | — | Universal Distribution Center LLC | 1 |
| — | — | — | — |
Frequently asked questions
What is Sensitive Tooth Polish used for?
Uses when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact aids in the prevention of cavities
Who makes Sensitive Tooth Polish?
Melaleuca, Inc. is the labeler of record for Sensitive Tooth Polish. 6 FDA label records share the active ingredient POTASSIUM NITRATE AND 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 Sensitive Tooth Polish come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Sensitive Tooth Polish 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 AND SODIUM FLUORIDE?
Yes. 6 FDA drug label records list POTASSIUM NITRATE AND 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 Sensitive Tooth Polish 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.