Over the Counter or “OTC” refers to non-prescription drug products that are safe and effective for use by the general public without seeking treatment by a health professional. The FDA has stated that “Over-the-counter (nonprescription) drug products play an increasingly vital role in America’s health care system.” (FDA Website on OTC Drugs”).
The FDA reviews over 80 classes of OTC drugs and approves monographs for each category. Once final monographs for a category or product are implemented, manufacturers can produce drugs that conform to these monographs without the need for additional FDA approval.
Our anti-inflammatory products and our Moisturizing Hand Sanitizer fall under the OTC category.
Contact us to see how we can work with you to develop new OTC products or how we can white label our product for you or contract manufacture your products.