The US FDA considers alcohol-based hand sanitizers as Over the Counter Products (OTC). The OTC are divided into two categories either health care antiseptics or consumer antiseptics. The registration pathway and indication depends heavily on the ingredients in the product.
Download our Whitepaper for a summary of the how Hand-Sanitizers are classified and how they are registered with the US FDA.
About Global Regulatory Partners Inc:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.