Which statement about labeling of topical medications is true?

• A. They must be labeled for external use only.
• B. Labeling varies by product.
• C. They do not require labeling.
• D. They are labeled for systemic use.

Answer: (B)

Labeling for topical medications varies by product because each product has different formulation, route of administration, and intended effect, all of which dictate what must appear on the label. Some topicals are meant for local action on the skin, so labels will provide directions on how much to apply, how often, and any precautions about contact with eyes or mucous membranes, plus warnings about skin reactions and storage. Others are designed to deliver medicine systemically through the skin, such as transdermal patches, and require information on dosing intervals, site rotation, how long to wear the patch, removal and disposal instructions, and systemic safety considerations. The ingredients, shelf life, storage conditions, and safety disclosures also vary with the product. Because of these differences, there is no single labeling rule that fits all topical meds; the labeling is specific to each product. The other statements are not accurate because some topicals can be used systemically, all medicines require labeling, and not all are labeled only for systemic use.