What information is NOT required on OTC labels?

The requirement for labeling on over-the-counter (OTC) medications is governed by regulations that aim to ensure consumer safety and proper usage. While the product name, the name and address of the manufacturer or distributor, and a list of active ingredients are all mandated components of OTC labels due to their importance in identifying the product and its uses, the batch number is not necessarily required on the label itself.

The batch number is primarily used for tracking and quality control purposes during manufacturing, serving as a means for manufacturers to trace products in case of a recall or quality issue. However, it doesn't provide relevant information for the consumer regarding the safe and effective use of the medication. Thus, while important for internal manufacturing processes, it does not meet the criteria of essential labeling information intended to inform consumers directly, making it the correct choice for information that is not required on OTC labels.