The Difference Between On-Label & Off-Label Botox Injections (Why We Offer Both)

The Difference Between On-Label & Off-Label Botox Injections (Why We Offer Both)

When it comes to your health and wellness, you obviously want what’s best. That’s why you might immediately gravitate toward the idea of an on-label Botox injection while shying away from an off-label Botox injection.

However, the reality isn’t so black and white. Botox has well-documented on-label and off-label uses, and medical spas around the country continue to offer treatments from both lists.

If you’re hesitant about the idea of an off-label injection, we completely understand. That’s why we’ve put together this guide on the differences between on-label and off-label Botox injections.

What Is An On-Label Injection?

Botox is a substance used for medical treatments. As such, it’s regulated by the Food and Drug Administration (FDA). For every substance that it approves and regulates, the FDA releases a “label.” This label informs the public of a product’s intended uses, recommended doses, possible side effects and more.

The label for Botox (a particular brand of neuromodulator produced by the company Allergan) contains only a short list of approved cosmetic uses. As of right now, these uses are:

  • Frown lines (glabellar lines)
  • Crow’s feet (wrinkles at the corners of the eyes)
  • Forehead lines

That’s it. Those are the FDA-approved cosmetic uses of Botox. And that’s all that “on label” really means—applications specifically “Approved by the FDA.” Injectors taking an on-label approach follow the same recommendations on the pattern, dosage and placement for every patient.

But, as you may have noticed, this list is missing several of the most popular Botox treatments. That’s because the rest of them are off-label injections.

What Is An Off-Label Injection?

An off-label injection is any usage of Botox that isn’t listed on the FDA label (or is listed with a note about Important Limitations). As you might have guessed by the short list above, most common Botox injections are actually off-label.

In fact, the following Botox Cosmetic treatments (all of which are extremely popular) are off-label:

  • Masseter (jaw muscle)
  • Chin dimples
  • Brow lifts
  • Nose lifts
  • Lip flips
  • Bunny Lines
  • Neck Lines

What’s more, many of the well-known medical applications for Botox are also off-label. Or, at least, some variations of them are.

For example, Botox has long been used to treat hyperhidrosis (excessive sweating) in the armpits. But as the FDA label for Botox notes, “The safety and effectiveness of BOTOX for hyperhidrosis in other body areas have not been established.” Nonetheless, people still use Botox to treat excessive sweating in the hands, feet and other areas.

The same is true of migraines. While the FDA writes that Botox injections are safe and effective for people who experience chronic migraines (15 or more days per month), it’s not recommended for people who have 14 migraines or less per month. Even so, people with less frequent migraines still use Botox for relief.

In other words, the FDA is incredibly specific about what it puts on its labels. And while we’re glad to see the FDA looking out for the health and safety of Americans, the truth is that government agencies can be conservative when it comes to new uses for existing science. At one point, zero uses of Botox were FDA-approved. Now, some are, and some aren’t. Some day, we might see even more current uses of Botox on the list.

So, keep in mind that off-label doesn’t explicitly mean that the FDA went through drug trials and decided that a substance wasn’t safe and/or effective. It may simply mean that they have yet to complete a trial.

Comparing On-Label and Off-Label Injections

As you now know, some common uses for Botox are listed on the FDA product label, while others are not. But is that the only difference?

To give you a clearer picture, let’s compare the two options in more detail.

Product Quality

First, let’s clear up one common misconception. Some patients might assume that the term “off-label Botox injection” refers to a knock-off brand or a shady practice. “Is an off-label injection really the same as an on-label one?” they ask.

The answer is yes. There is no difference between the Botox used for on-label injections and the Botox used for off-label injections—it’s the same substance. The only difference is the injection site. To sum it up, here’s what you need to remember:

  • On-label injections are only in FDA-approved areas for FDA-approved reasons
  • Off-label injections cover more parts of the body

Safety

“But is that safe?” That’s often the second question a patient might ask. Of course, patient safety is always the top priority, so we want to be as transparent here as possible.

While we won’t pretend to know more than the FDA, we do work with Botox nearly every day, and we’ve seen safe, impressive results in many areas that aren’t covered in the FDA label.

It’s important to note that we (and other medspas that offer off-label injections) are very careful about administering Botox injections safely. We follow science and experience. While the FDA may not have approved a particular usage, the pharmaceutical companies that develop Botox and other neuromodulators have done extensive research and published white papers based on the evidence.

So, are on-label injections as safe as off-label ones? As long as they’re done correctly, we believe they are. In our opinion, it’s more important to judge a medspa’s safety by its qualities—its patient satisfaction, longevity in the market, safety record, patient reviews and staff training and credentials—than by its offerings.

Customizability

Finally, we reach the crucial difference between on-label and off-label injections: Flexibility.

When a medspa only offers on-label Botox injections, they commit to following all recommendations exactly as listed. Unfortunately, the result is somewhat of a “cookie cutter” approach to aesthetics: A belief that all patients can be treated identically.

However, Botox injections are about art as much as they are science. And to put that artistic eye to the test—to provide patients with the exact look they’ve been dreaming of—you sometimes have to go off-label. To truly address a patient’s wants and needs, you need the flexibility and customizability of off-label injections.

Of course, being flexible with aesthetic solutions requires expertise through hands-on training. That’s why our trainees undergo a extensive training as well as ongoing advanced training programs to determine if they have the eye to inject aesthetically and are meticulous with the process. This program covers injectable and didactic anatomy, physiology, physics, rheology and more. It sets us apart from other medspas, and, as a result, Derma Health is ranked #1 in providing Botox injections throughout the Southwest.

Once again, don’t think that “off-label” means “unsafe.” No provider should ever put a patient’s request for a specific look over their safety. And any medical spa that offers off-label treatments should still follow all health and safety guidelines as well as ensure their medical staff has received extensive and rigorous training—that’s what we do, and we’re proud of it.

At Derma Health, We Leave the Choice To You

In the end, we’re not here to convince you to come in for off-label injections. We understand that everyone has their preferences. If you’d rather stick to the on-label applications of Botox, that’s no problem—we’re happy to help! There’s a reason we offer both options.

But we do feel it’s important to shed some light on the differences (or lack thereof) between on-label and off-label injections.

Whether you’re hoping for an on-label Botox injection or an off-label one, the team at Derma Health Skin & Laser is here for you. Our highly-trained injectors and aestheticians learn to treat every part of the face—not just specific areas—so you can receive the personalized treatment you’re looking for.

Interested in our Botox treatments? Start by booking a consultation with us to learn more. And if you ever have questions or concerns about Botox usage—whether it’s on- or off-label—don’t hesitate to bring them to us.

Sources: 

Food and Drug Administration. Botox Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf

Food and Drug Administration. MEDICATION GUIDE: BOTOX® | BOTOX® Cosmetic. https://www.fda.gov/media/77359/download

International Hyperhidrosis Society. OnabotulinumtoxinA Injections (Botox®). https://www.sweathelp.org/hyperhidrosis-treatments/botox.html

Food and Drug Administration. Botox Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdfFood and Drug Administration. Botox Label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103000s5232lbl.pdf

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