NEUTRA MAXX 5000

SODIUM FLUORIDE ORAL HUMAN PRESCRIPTION DRUG

NEUTRA MAXX 5000 is an FDA drug label for the active ingredient SODIUM FLUORIDE manufactured by Massco Dental A Division of Dunagin Pharmaceuticals administered by ORAL. 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 20231217.

Generic name
SODIUM FLUORIDE
Manufacturer
Massco Dental A Division of Dunagin Pharmaceuticals
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Dosage form
N/A
NDC
63783-504
Application
N/A
Label effective
20231217

About this product

NEUTRA MAXX 5000 is an FDA-registered drug product whose active ingredient is SODIUM FLUORIDE. It is labelled by Massco Dental A Division of Dunagin Pharmaceuticals taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 63783-504, label effective 20231217. It is one of 263 FDA drug label records sharing the active ingredient 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 SODIUM FLUORIDE are most often described in connection with: directions directions, unless instructed, dental professional, children years, brushing teeth, rinsing apply, thin ribbon, toothbrush mouth. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

ACTIVE INGREDIENTS ACTIVE INGREDIENT PURPOSE SODIUM FLUORIDE (NaF) 1.1% (w/v) ANTICAVITY INACTIVE INGREDIENTS DEIONIZED WATER, XYLITOL, POTASSIUM NITRATE, SODIUM CARBOXYMETHYLCELLOSE, GLYCERIN, FLAVORING,SODIUM SACCHARIN, SODIUM PHOSPHATE .

Indications & Usage

DIRECTIONS DIRECTIONS: (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL) ADULTS AND CHILDREN 6 YEARS AND OLDER: USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE. AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE. BEFORE BEDTIME IS BEST. ADULTS SHOULD EXPECTORATE AFTER USE. CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH THOROUGHLY. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER USE.

Warnings

WARNINGS WHEN USING THIS PRODUCT DO NOT SWALLOW UNLESS TOLD TO DO SO BY A DENTIST OR PHYSICIAN.

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How products containing SODIUM FLUORIDE compare

FDA lists 263 drug label records with 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
— — Colgate-Palmolive Company 34
— — The Procter & Gamble Manufacturing Company 25
— — Church & Dwight Co., Inc. 14
— — Burkhart Dental Supply Inc 12
— — Dharma Research, inc. 12

Frequently asked questions

What is NEUTRA MAXX 5000 used for?
DIRECTIONS DIRECTIONS: (UNLESS INSTRUCTED OTHERWISE BY YOUR DENTAL PROFESSIONAL) ADULTS AND CHILDREN 6 YEARS AND OLDER: USE ONCE A DAY AFTER BRUSHING TEETH WITH TOOTHPASTE. AFTER RINSING, APPLY THIN RIBBON OF GEL TO TEETH WITH TOOTHBRUSH OR MOUTH TRAYS FOR AT LEASE ONE MINUTE. BEFORE BEDTIME IS BEST. ADULTS SHOULD EXPECTORATE AFTER USE. CHILDREN AGES 6-16 SHOULD EXPECTORATE GEL AND RINSE MOUTH …

Who makes NEUTRA MAXX 5000?
Massco Dental A Division of Dunagin Pharmaceuticals is the labeler of record for NEUTRA MAXX 5000. 263 FDA label records share the active ingredient 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 NEUTRA MAXX 5000 come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is NEUTRA MAXX 5000 prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing SODIUM FLUORIDE?
Yes. 263 FDA drug label records list 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 NEUTRA MAXX 5000 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.