OTC Monographs

OTC Monograph: definition & purpose

A Category IV Monograph outlines the conditions of use and labelling requirements for an Over-the- Counter product. These Monographs provide direction for marketing drugs that have a well- characterized safety and efficacy profile. An establishment may use a Category IV Monograph as reference in a submission when the product and its labelling are consistent with the regulations. Some examples of Category IV Monographs include Acne Therapy, Medicated Skin Care Products, and Sunscreen Monographs.