The objective of this guideline is to define the minimum stability data package to support the commercial distribution of OTC monograph drug products in the United States per climatic zone.
Child-resistant packaging is used to reduce the risk of poisoning in children via the ingestion of potentially hazardous items including certain prescription and OTC medications, pesticides, and household chemicals.
The advertising of nonprescription, over-the-counter medicines helps acquaint the public with these products and must be truthful, not misleading, and must meet high standards reflecting the nature of the product advertised.
