Glossary
On-Label / Off-Label
Whether a promotional claim stays inside a drug's approved prescribing information, or doesn't.
The label is a drug's approved prescribing information: the indications, population, and dosing it's approved for. On-label means a claim stays inside that scope. Off-label means it doesn't, regardless of whether the underlying clinical fact is true. A statement can be scientifically accurate and still be off-label if it describes a population, indication, or dose the label doesn't cover.
For the full explanation, including common ways this gets misread: What does on-label and off-label actually restrict?