The article is a review of modern literature and an analysis of the legal framework regarding the use of local anesthetics in children under 4 years of age. There is a discussion of the validity of the off-label principle. In the domestic and foreign literature, there are publications highlighting the use of drugs based on 4% articaine in children under 4 years old, despite age-related contraindications according to the instructions. It is necessary to pay special attention to the regulatory status of the instructions for the medical use of the medicinal product. Summarizing the presented arguments, we can talk about the available spectrum of clinical studies, meta-analyzes and RCT data on the use of articaine in dental practice in children under 4 years of age, which indicates its effectiveness and is considered a safe alternative to lidocaine for use. in children of all ages.