Antiplaque solution

Antiplaque solution is an FDA-registered drug product whose active ingredient is CETYLPYRIDINIUM CHLORIDE. It is labelled by Sage Products LLC taken by buccal and marketed as a human otc drug product. Identifiers on file: NDC 53462-275, application M022, label effective 20260629. It is one of 14 FDA drug label records sharing the active ingredient CETYLPYRIDINIUM CHLORIDE. 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 CETYLPYRIDINIUM CHLORIDE are most often described in connection with: prevention plaque, leads gingivitis. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Aids in the removal and prevention of plaque that leads to gingivitis.

Directions Before opening, turn package over, burst solution packet with thumbs. Peel lid to open. Remove Mouth Moisturizer and Applicator Swab. Attach Toothbrush to suction line. Clean teeth and oral cavity for approximately one minute. To suction, place thumb over port. To clear tubing, rinse with sterile saline or appropriate solution. Discard Toothbrush. Reattach Covered Yankauer to suction line. Place Mouth Moisturizer on Applicator Swab. Apply as needed to lips and inside mouth. Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution. Children ages 6 to 12 years: supervise use. Children under 6 years of age: do not use. Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands. Ensure foam is intact after use. If not, remove any particles from oral cavity.

Warnings Stop use and ask a dentist if: Gingivitis, bleeding or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 year of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 14 drug label records with CETYLPYRIDINIUM CHLORIDE 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Antiplaque solution used for?
Uses Aids in the removal and prevention of plaque that leads to gingivitis.

Who makes Antiplaque solution?
Sage Products LLC is the labeler of record for Antiplaque solution. 14 FDA label records share the active ingredient CETYLPYRIDINIUM CHLORIDE, 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 Antiplaque solution come in?
administered by buccal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Antiplaque solution 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 CETYLPYRIDINIUM CHLORIDE?
Yes. 14 FDA drug label records list CETYLPYRIDINIUM CHLORIDE 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 Antiplaque solution been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.