U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
OTC vs. Prescription
Intended Use

Your product's intended use(s) is very important. Here's why:

How does the FDA define “intended use?”

“Intended use is the objective intent of the persons legally responsible for the labeling of drugs. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article.”

Aaron with thought bubble: What is the intended use of our cough suppressant?
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