Wrinkle Treatment for Frown Lines Between the Brows: BOTOX® Cosmetic Is FDA Approved

What About Safety

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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:

verify the identity, potency, purity, and stability of the "ingredients," and
demonstrate that the drug is safe and effective for its intended use.

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.

For more information about BOTOX^® Cosmetic and how it differs from other products, see What About Other Procedures & Products? and BOTOX® Cosmetic May Work for You.

The photos featured on this Web site are of actual BOTOX^® Cosmetic users.

BOTOX^® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe frown lines between the brows in people 18 to 65 years of age.

BOTOX^® Cosmetic should not be used in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any ingredient in the formulation.

Patients with neurological disorders such as ALS, myasthenia gravis, or Lambert-Eaton syndrome may be at increased risk of serious side effects. The most common side effects include headache, respiratory infection, flu syndrome, temporary eyelid droop, and nausea.

BOTOX^® Cosmetic is administered by physicians and is available only by prescription. Please see the full prescribing information.

BOTOX^® Cosmetic is approved for the temporary treatment of moderate to severe frown lines between the brows in people ages 18–65.

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.

BOTOX^® Cosmetic is administered by physicians and is available only by prescription. Please see the full prescribing information.

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