PRO-SYS

PRO-SYS is an FDA-registered drug product whose active ingredient is ORAL WOUND CLEANSER. It is labelled by Forward Science Technologies LLC taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 70275-201, application M022, label effective 20260730. 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 ORAL WOUND CLEANSER are most often described in connection with: removal phlegm, secretions associated, occasional sore, cleansing minor, gum inflammation, dental procedures, dentures orthodontic, appliances accidental. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth. • For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. • For temporary use to cleanse canker sores. • Assists in the removal of foreign material from minor oral wounds.

Directions • Adults and children 2 years of age or older: rinse half a capful (two teaspoons or 10 mL) around the mouth over the affected area for at least 1 minute, then spit out. • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician. • Children under 12 years of age should be supervised in the use of the product. • Children under 2 years of age: Consult a dentist or physician.

Warnings Do not use this product for more than 7 days unless directed by a dentist or physician. When using this product, do not swallow. Stop use and ask a dentist or physician if: • sore mouth symptoms do not improve in 7 days; • irritation, pain, or redness persists or worsens; • swelling, rash, or fever develops.

What is PRO-SYS used for?
Uses • Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth. • For temporary use in cleansing minor wounds or minor gum inflammation resulting from minor dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums. • For temporary use to cleanse canker sores. • Assists in the removal of foreign …

Who makes PRO-SYS?
Forward Science Technologies LLC is the labeler of record for PRO-SYS.

What form does PRO-SYS 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 PRO-SYS 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.

Has PRO-SYS 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.