Colgate Optic White Renewal Brilliant Shine

Colgate Optic White Renewal Brilliant Shine is an FDA-registered drug product whose active ingredient is SODIUM MONOFLUOROPHOSPHATE. It is labelled by Colgate-Palmolive Company taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 35000-955, application M021, label effective 20260626. It is one of 59 FDA drug label records sharing the active ingredient SODIUM MONOFLUOROPHOSPHATE. 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 MONOFLUOROPHOSPHATE are most often described in connection with: helps protect, against cavities. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use helps protect against cavities

Directions adults and children 6 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 physician children 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 6 years do not use unless directed by a dentist or physician

Warnings 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 59 drug label records with SODIUM MONOFLUOROPHOSPHATE 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 Colgate Optic White Renewal Brilliant Shine used for?
Use helps protect against cavities

Who makes Colgate Optic White Renewal Brilliant Shine?
Colgate-Palmolive Company is the labeler of record for Colgate Optic White Renewal Brilliant Shine. 59 FDA label records share the active ingredient SODIUM MONOFLUOROPHOSPHATE, 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 Colgate Optic White Renewal Brilliant Shine 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 Colgate Optic White Renewal Brilliant Shine 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 MONOFLUOROPHOSPHATE?
Yes. 59 FDA drug label records list SODIUM MONOFLUOROPHOSPHATE 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 Colgate Optic White Renewal Brilliant Shine 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.