Topical Antiseptic Products: Hand Sanitizers and ...- fda monograph hand sanitizer device ,FDA issues final rule on safety and effectiveness of consumer hand sanitizers, 2019 If Soap and Water Are Not Available, Hand Sanitizers May Be a Good Alternative, 2019FDA OTC Drug Monograph - FDA Registration - FDA AgentOTC monographs define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in OTC final monograph, companies can manufacture and market that OTC product without FDA pre-approval. Examples of Drugs in FDA Monograph