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
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Drug Facts Labeling

The Drug Facts labeling is designed to facilitate reading and understanding information presented on the label.

It should be noted that products having both drug and cosmetic uses, like lipstick that also acts as a sunscreen, must comply with both drug labeling and cosmetic labeling requirements.

In addition, the listing of inactive ingredients and cosmetic ingredients must comply with the cosmetic labeling requirements, appearing in decreasing order of predominance. The Drug Facts labeling requirements specify that inactive ingredients are to be listed alphabetically. Please note that this is not the case for OTC drug-cosmetic combination products.

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Mattie holding a large print of a drug's drug facts label. In front of her is a text box. Select the D-link for additional information.
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