Off-label use refers to using a product, medication, or treatment in a way other than what was approved by the FDA. For example, BOTOX® Cosmetic is FDA-approved for the temporary improvement of moderate to severe (glabellar) frown lines between the eyebrows, and for the temporary improvement of moderate to severe (lateral canthal) crow’s feet lines around the side of the eyes in adults younger than 65 years of age. However, in addition to these areas, BOTOX® Cosmetic is also used to treat transverse forehead lines, bunny lines along the side of the upper nose, vertical lip lines, cobble stone irregularities of the lower anterior chin, and down turned corners of the mouth related to muscle hyperactivity. Despite all these other cosmetic applications for the face, you will never hear the company advertise these uses. That is because the FDA will not allow manufacturers to advertise the use of their products for areas or applications in which they are not FDA-approved. In a similar way, the use of BOTOX® Cosmetic in a patient 66 years old would also be considered off-label. Once again, it is fine to use BOTOX® Cosmetic injections in individuals older than 65 years of age if they are deemed appropriate candidates for the treatment.

The same is true for soft tissue filler injections. Many of these products are typically FDA-approved for the treatment of moderate to severe facial lines and folds around the mouth, such as the nasolabial folds. But these products are used to treat deep lines in the forehead and glabella, to correct contour irregularities of the face and cheeks, to correct minor nasal asymmetry or camouflage a mild dorsal hump, to increase lip volume and fullness, to treat vertical lip lines, to improve the peri-mental hollows and the pre-jowl sulcus, and almost anywhere volume restoration is required.

So in conclusion, it is fine to use Botox and fillers in any of the applications described above. But, since these products are not FDA-approved for these indications, you will never see any type of advertisement describing use for these areas. Instead, your plastic surgeon can explain how these products are best suited to help you achieve the look you want.