BOTOX^® Cosmetic is a simple, nonsurgical, physician-administered treatment that can temporarily smooth moderate to severe frown lines between the brows in people from 18 to 65 years of age. It is the only treatment of its type approved by the Food and Drug Administration .

One 10-minute treatment—a few tiny injections—and within days there's a noticeable improvement in moderate to severe frown lines between the brows, which can last up to 4 months. Results may vary.

BOTOX^® Cosmetic is a purified protein produced by the Clostridium botulinum bacterium, which reduces the activity of the muscles that cause those frown lines between the brows to form over time.

In 2005, almost 3.3 million procedures were performed with FDA-approved BOTOX^® Cosmetic.

After treatment with BOTOX^® Cosmetic, you may look in the mirror and see a marked improvement in the moderate to severe frown lines between your brows. But BOTOX^® Cosmetic will not radically change your facial appearance. You can still frown or look surprised—without the wrinkles and creases between your brows.

BOTOX^® Cosmetic works by temporarily reducing the contractions of the muscles that cause those persistent frown lines that have developed between your brows over time.

Within days, you may see an improvement that can last up to 4 months. Results may vary. If you do not continue treatments, the frown lines between your brows will gradually look like they did before treatment.

Do not use BOTOX^® Cosmetic if you:

• have an infection where BOTOX^® Cosmetic will be injected
• are allergic to any of the ingredients in BOTOX^® Cosmetic
• are pregnant or think you might be pregnant.

What should I tell my doctor before using BOTOX^® Cosmetic?

Only your doctor can decide if BOTOX^® Cosmetic is right for you. Before starting treatment, tell your doctor if you:

• have any diseases that affect your nerves and muscles. These diseases may increase your chance of side effects with BOTOX^® Cosmetic treatment.
• are breastfeeding
• are planning to become pregnant soon.

Can any of my medicines interact with BOTOX^® Cosmetic?

Be sure that your doctor knows the names of all the medicines you are using, including:

• antibiotics used to treat infections, such as gentamicin, tobramycin, clindamycin, and lincomycin
• medicines used to treat heart rhythm problems, such as quinidine
• medicines used to treat different conditions, such as myasthenia gravis or Alzheimer’s disease.

As with all prescription medicines, you should also notify your doctor if you are taking any over-the-counter medicines or herbal products.

You've heard it many times before: A product is advertised as "FDA-approved." But what does that really mean?

In the United States, prescription drugs and biologics are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market. The Food and Drug Administration (FDA) reviews the results of these studies to:

What about BOTOX^® Cosmetic?

BOTOX^® Cosmetic received FDA approval in 2002 for the temporary treatment of moderate to severe frown lines between the brows in people 18 to 65 years of age. BOTOX^® Cosmetic is available by prescription only.

Important Safety Information

Serious heart problems and serious allergic reactions have been reported rarely. If you think you’re having an allergic reaction or other unusual symptoms, such as difficulty swallowing, speaking or breathing, call your doctor immediately. The most common side effects following injection include temporary eyelid droop and nausea. Localized pain, infection, inflammation, tenderness, swelling, redness, and/or bleeding/bruising may be associated with the injection. Patients with certain neuromuscular disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects.