Our goal is to make both safe and effective topical anesthetics that temporarily help control pain associated with superficially painful conditions. Pain control is vital for the performance of the duties of professionals in the field of cosmetic and medical micropigmentation. However, to date no topicals, or pigments, are FDA approved for use in permanent cosmetics specifically. Use of such products is considered off label use.
The FDA has guidelines for OTC topical anesthetics for the temporary control of pain associated with cuts, burns, stings and anorectal discomfort. The FDA does not regulate the end-use of a specific OTC product. Users of OTC drugs (whether health care professional or the general public) necessarily take on the obligation of using them properly. One point of interest is that the FDA has recognized the use of topical anesthetics in permanent eyeliner since at least 1993. (Click here for FDA article on eyeliner safety 1993). Keep all topicals out of direct eye contact.