UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE

POTASSIUM NITRATE AND SODIUM FLUORIDE DENTAL HUMAN OTC DRUG

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE is an FDA drug label for the active ingredient POTASSIUM NITRATE AND SODIUM FLUORIDE manufactured by Universal Distribution Center LLC 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 20231117.

Generic name
POTASSIUM NITRATE AND SODIUM FLUORIDE
Manufacturer
Universal Distribution Center LLC
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
52000-109
Application
M022
Label effective
20231117

About this product

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE is an FDA-registered drug product whose active ingredient is POTASSIUM NITRATE AND SODIUM FLUORIDE. It is labelled by Universal Distribution Center LLC taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 52000-109, application M022, label effective 20231117. 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: builds increasing, protection against, painful sensitivity, teeth due, cold heat, acids sweets, contact aids, prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredients Potassium Nitrate 5% Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)

Indications & Usage

Uses builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact. aids in the prevention of dental cavities.

Dosage & Administration

Directions adults and children 12 years of age and older apply at least a 1-inch strip of product onto soft bristle toothbrush brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult a dentist or doctor.

Warnings

Warning

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

Sensitivity and Gum with Cavity Protection

Health and Natural Beauty USA Corp 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 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE used for?
Uses builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact. aids in the prevention of dental cavities.

Who makes UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE?
Universal Distribution Center LLC is the labeler of record for UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE. 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 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE 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 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE 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 UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE 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.