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.
It is important to know that there are no topical anesthetics specifically approved for permanent makeup by the FDA. However, an article has been written by the FDA which describes the use of anesthetics being applied before eyeliner in 1993. There are non-prescription, OTC topicals approved for many uses including minor cuts, scrapes, insect bites, abrasions and anorectal. The following OTC topical anesthetics are registered with the FDA. The National Drug Code, part of the FDA's drug product listing, is assigned to each of the products listed below. The 1983 FDA tentative final monograph suggests that products containing a combination of local anesthetics are not considered OTC (over-the-counter). Unit Dose has and does produce combination topicals for professional use only, all of which contain from 2% to 5% total topical anesthetic concentration. Read the legal opinion in the following article about topical anesthetics for permanent makeup written 10 years ago by an attorney specializing in FDA matters. As to other countries, regulations vary. AR= Anorectal OTC monograph permits, separately, 5% Lidocaine as well as 2% Tetracaine. Unit Dose products are properly labeled as required by the FDA. The use of properly prepared and labeled OTC topical anesthetics is determined solely by the end user.
The following topical anesthetics by Unit Dose are Over-the-Counter Strength (OTC) and registered with the FDA. The Number following the name is the NDC or National Drug Code assigned to each product by the FDA.
Numquick Gel: 67194-005-01
Numquick Spray: 67194-007-01
Healquick Stick: 67194-012-01
Topical anesthetics combined with antibiotics are not only detrimental but dangerous to the public due to a high incidence of allergic reactions reported. Topical antibiotics have been discontinued by some doctors from their practices, as reported by Dr. Charles Zwerling, American Academy of Micropigmentation Chairman of the Board and Board Certified Ophthalmologist.