Anticaries
The FDA established an OTC monograph specifically for over-the-counter (OTC) anticaries drugs, which are products designed to help prevent cavities. This monograph outlines the conditions under which these topical tooth products are considered safe and effective. The main active ingredient allowed by the monograph is sodium fluoride, at a specific concentration range for gels, pastes, and powders. This regulation helps ensure that consumers have access to cavity-fighting toothpastes with the appropriate amount of fluoride for safe and effective use.
Anticaries - Active Ingredients and OTC Monograph Number
| Active Ingredients | OTC Monograph Number |
|---|---|
| Sodium fluoride | M021.10 (Part 355) |
| Sodium monofluorophosphate | M021.10 (Part 355) |
| Stannous fluoride | M021.10 (Part 355) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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