Legal Age for Botox?

Dear Hannah
The FDA approval of BOTOX for certain medical indications is for ages 12 and up. The approved age range for BOTOX cosmetic is approved for individuals who are 65 years old or less. However, these are essentially guidelines and the law allows physicians to use the judgment and use BOTOX in ways that are not FDA approved. This type of usage is called off-label and many drugs are used in an off-label fashion with great benefit to the individual receiving treatment.

For cosmetic purposes, the package insert recommends that Botox® “is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and /or procerus muscle activty in adult patients ≤ 65 years of age”. Please keep in mind that physicians may clinically decide to use Botox® in older or younger patients and in other anatomic areas as an as “off label” application if specific informed consent is obtained. For therapeutic and medical applications, the age drops to 12 years.