One frequently asked question I get is, what on earth do the terms on-label and off-label mean? In general, these labels refer to an FDA approval or clearance status of a certain type of drug or medication.

Specifically, on-label means that a medicine was studied, approved and cleared by the FDA for a particular use. Off-label means that your doctor is using his or her own clinical judgment to determine if that medicine is right for you, but it hasn’t gone through the rigorous approval process by the FDA.  


Examples of off-label uses

One of the best examples of this is the use of Botox to treat horizontal forehead lines. That was an off-label use for over a decade until recently when Botox became FDA approved for treating horizontal forehead lines now making it an on-label use. It didn’t all of a sudden become safer in the past couple of years, but it did go from off-label to on-label status.

Some of the most common cosmetic interventions in the U.S., and the world, are off-label uses of products. A few examples include, toxins to slim the masseter muscles, fillers in the under eye or tear trough area, nonsurgical rhinoplasty, Sculptra for butt augmentation, and Kybella for dissolving bra-roll fat. Those are all examples of procedures that have been performed thousands and hundreds of thousands of times by countless medical professionals.


What to consider

The real thing to think about when wondering about risks related to any procedure is, “Is this procedure right for me? Is it being tailored to my unique anatomic characteristics? And is my doctor talking to me about the risks and benefits of that procedure?”

A doctor has the ability to use any medication on-label or off-label, but will use their expertise to ensure patient safety and optimal results no matter the treatment.


Each week, Dr. Lara Devgan answers questions submitted by readers like you. If you want to ask Dr. Devgan a question about plastic surgery, aesthetic treatments, or skin care, you can do so here