Sensitivity and Gum with Cavity Protection

POTASSIUM NITRATE AND SODIUM FLUORIDE DENTAL HUMAN OTC DRUG

Sensitivity and Gum with Cavity Protection is an FDA drug label for the active ingredient POTASSIUM NITRATE AND SODIUM FLUORIDE manufactured by Health and Natural Beauty USA Corp administered by DENTAL. 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 20260522.

Generic name
POTASSIUM NITRATE AND SODIUM FLUORIDE
Manufacturer
Health and Natural Beauty USA Corp
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
63404-2210
Application
M022
Label effective
20260522

About this product

Sensitivity and Gum with Cavity Protection is an FDA-registered drug product whose active ingredient is POTASSIUM NITRATE AND SODIUM FLUORIDE. It is labelled by Health and Natural Beauty USA Corp taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 63404-2210, application M022, label effective 20260522. 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: aids prevention, cavities helps, reduce 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.

Active ingredients

ACTIVE INGREDIENT PURPOSE Sodium Monofluorophosphate 0.76% (0.14 W/V Fluoride Ion) Anticavity Potassium Nitrate 5% Antihypersensitivity

Indications & Usage

USE 1) Aids in prevention of cavities. 2) Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact.

Dosage & Administration

DIRECTIONS Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft-bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

Warnings

WARNINGS Keep out of reach of children. "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 longer than 4 weeks unless recommended by a dentist or doctor."

More products with the same ingredient

POTASSIUM NITRATE AND SODIUM FLUORIDE

Opal by Opalescence Sensitivity

Ultradent Products, Inc. View label

Opalescence Sensitivity Relief Whitening

Ultradent Products, Inc. View label

Opalescence Whitening Sensitivity Relief

Ultradent Products, Inc. View label

Sensitive Tooth Polish

Melaleuca, Inc. View label

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE

Universal Distribution Center LLC View label

How 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 formProductsManufacturerProducts
— — Ultradent Products, Inc. 3
— — Health and Natural Beauty USA Corp 1
— — Melaleuca, Inc. 1
— — Universal Distribution Center LLC 1
— — — —

Frequently asked questions

What is Sensitivity and Gum with Cavity Protection used for?
USE 1) Aids in prevention of cavities. 2) Helps reduce painful sensitivity of the teeth to cold, heat, acids, and sweets, or contact.

Who makes Sensitivity and Gum with Cavity Protection?
Health and Natural Beauty USA Corp is the labeler of record for Sensitivity and Gum with Cavity Protection. 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 Sensitivity and Gum with Cavity Protection 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 Sensitivity and Gum with Cavity Protection 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 Sensitivity and Gum with Cavity Protection 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.