Consumers use non-prescription drugs without the supervision of a healthcare professional. The non-prescription drug’s label is intended to empower consumers to appropriately select and use the product safely and effectively. As such, the FDA is looking to improve the consistency of labeling for non-prescription drugs. It recently announced draft guidance entitled “Statement of Identity and Strength — Content and Format of Labelling for Human Non-prescription Drug Products,” which provides recommendations on the content and format of the required statement of identity and the drug’s strength, both of which appear on the labeling of human non-prescription drug products. The recommendations are intended to help manufacturers, packers, distributors, applicants, and sponsors ensure consistent content and format of the statement of identity and strength for all non-prescription drug labeling.

One of the prominent features required to be on the principal display panel (PDP) of the drug product is the statement of identity. The PDP, often the front panel of the label, is the part of the non-prescription drug’s label most likely to be displayed to the consumer in retail sales. The statement of identity consists of the drug’s established name, if it has one, followed by an accurate statement of the general pharmacological category/categories, or the drug’s principal intended action(s) (i.e., “clotrimazole cream, antifungal”). This information tells the consumer what the drug is and its intended use. The drug strength is also often found on the PDP. Consistent content and format of the statement of identity and drug strength may aid consumers in comparing different non-prescription drugs and assist consumers in selecting an appropriate product.

You can access and download the guidance here.

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