ORTHO GUARD

ORTHO GUARD 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 otc drug product. Identifiers on file: NDC 63783-400, application M021, 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.

Across FDA labelling, products containing SODIUM FLUORIDE are most often described in connection with: prevention dental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use Aids in the prevention of dental decay

DIRECTIONS: Use As Directed ADULTS AND CHILDREN 6 YEARS AND OLDER USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE. VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING. INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING. CHILDREN UNDER 6 CONSULT A DENTIST OR PHYSICIAN

Warnings When using this product, do not swallow unless to do so by a dentist or physician. If more solution is accidentally swallowed than used for rinsing, get medical help or contact a Poison Control Center immediately.

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.

What is ORTHO GUARD used for?
Use Aids in the prevention of dental decay

Who makes ORTHO GUARD?
Massco Dental A Division of Dunagin Pharmaceuticals is the labeler of record for ORTHO GUARD. 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 ORTHO GUARD 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 ORTHO GUARD 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 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 ORTHO GUARD 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.