What is the definition of a label in regulatory terms?

In regulatory terms, a label refers specifically to any display of written, printed, or graphic matter that is affixed to the immediate container or package of a product. This definition encompasses the information that is required by regulations to be present on product packaging, which may include the product name, ingredients, net quantity, and other necessary details as mandated by regulatory authorities.

This clarity in definition is crucial for compliance with regulations, as the label serves as a primary means of communicating important safety and usage information to consumers and healthcare professionals. It is not limited to promotional materials, instructions for use, or specific warning notices; rather, it covers a broader scope of information integrated into the product's packaging itself. This ensures that consumers have access to essential information to make informed choices about the products they use.