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
Requirements for All OTC Products

In addition to registering, listing, and manufacturing requirements, OTC drugs also share requirements when it comes to their labeling. You may ask, what labeling requirements apply to all OTC products? Let's answer that question by defining what the term “labeling” means.

Labeling is defined as all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such an article. Depending on the circumstances, labeling may include packaging, product inserts, Web sites, and other promotional materials.

Section 201(k) of the Act defines the term "label" as, "a display of written, printed, or graphic matter upon the immediate container of any article."

What kind of information do you think must appear on a label? Select the photo of Larry to learn more.


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