Therabreath Deep Clean

Therabreath Deep Clean is an FDA-registered drug product whose active ingredient is STANNOUS FLUORIDE. It is labelled by Church & Dwight Co., Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 10237-270, application M021, label effective 20260821. It is one of 19 FDA drug label records sharing the active ingredient STANNOUS 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 STANNOUS FLUORIDE are most often described in connection with: prevention dental, decay helps, prevent gingivitis, early form, gum disease, bleeding gums, harmful effects, plaque associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • aids in the prevention of dental decay • helps prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis

Directions • do not swallow • supervise children as necessary until capable of using without supervision adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years of age consult a dentist or doctor

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 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 19 drug label records with STANNOUS 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.

2 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 Therabreath Deep Clean used for?
Uses • aids in the prevention of dental decay • helps prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis

Who makes Therabreath Deep Clean?
Church & Dwight Co., Inc. is the labeler of record for Therabreath Deep Clean. 19 FDA label records share the active ingredient STANNOUS 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 Therabreath Deep Clean 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 Therabreath Deep Clean 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 STANNOUS FLUORIDE?
Yes. 19 FDA drug label records list STANNOUS 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 Therabreath Deep Clean been recalled?
2 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.