Its requirements are set out in 21 CFR 201.66. The panel covers active ingredients, uses, warnings, directions, other information, inactive ingredients and questions, in a consistent layout so consumers can find and compare information across products.

Why it matters for labeling

The format is prescriptive, so errors tend to be layout and wording errors rather than content errors: a heading out of order, text below the minimum size, or a warning that has been shortened. They are easy to miss in a visual check, and they matter more because the product is bought without a prescriber's involvement.

Common mistakes

  • Headings or sections in the wrong order
  • Type smaller than the minimum
  • Warnings reworded or cut short
  • Inactive ingredients that don't match the current formulation

Sources