UNIVERSAL ANTI-CAVITY FLUORIDE

SODIUM MONOFLUOROPHOSPHATE DENTAL HUMAN OTC DRUG

UNIVERSAL ANTI-CAVITY FLUORIDE is an FDA drug label for the active ingredient SODIUM MONOFLUOROPHOSPHATE 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 20231116.

Generic name
SODIUM MONOFLUOROPHOSPHATE
Manufacturer
Universal Distribution Center LLC
Product type
HUMAN OTC DRUG
Route
DENTAL
Dosage form
N/A
NDC
52000-111
Application
M021
Label effective
20231116

About this product

UNIVERSAL ANTI-CAVITY FLUORIDE is an FDA-registered drug product whose active ingredient is SODIUM MONOFLUOROPHOSPHATE. It is labelled by Universal Distribution Center LLC taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 52000-111, application M021, label effective 20231116. It is one of 59 FDA drug label records sharing the active ingredient SODIUM MONOFLUOROPHOSPHATE. 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 SODIUM MONOFLUOROPHOSPHATE are most often described in connection with: regular brushing, flouride toothpaste, helps protect, teeth against, cavities aids, prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient Sodium Monofluorophosphate 0.76% (1000 ppm)

Indications & Usage

Uses regular brushing with flouride toothpaste helps protect teeth against cavities aids in the prevention of dental cavities.

Dosage & Administration

Directions adults and children of 2 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist. do not swallow. to minimize swallowing, use a pea-sized amount in children under 6 years old. supervise children's brushing until good habits are established. children under 2 years: ask a dentist before use. Children under 12 years of age: Consult a dentist or doctor

Warnings

Warning

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How products containing SODIUM MONOFLUOROPHOSPHATE compare

FDA lists 59 drug label records with SODIUM MONOFLUOROPHOSPHATE 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
— — Colgate-Palmolive Company 17
— — Tom's of Maine, Inc. 14
— — Universal Distribution Center LLC 4
— — White Glo USA Inc 4
— — Wessco International 3

Frequently asked questions

What is UNIVERSAL ANTI-CAVITY FLUORIDE used for?
Uses regular brushing with flouride toothpaste helps protect teeth against cavities aids in the prevention of dental cavities.

Who makes UNIVERSAL ANTI-CAVITY FLUORIDE?
Universal Distribution Center LLC is the labeler of record for UNIVERSAL ANTI-CAVITY FLUORIDE. 59 FDA label records share the active ingredient SODIUM MONOFLUOROPHOSPHATE, 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 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 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 SODIUM MONOFLUOROPHOSPHATE?
Yes. 59 FDA drug label records list SODIUM MONOFLUOROPHOSPHATE 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 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.