BOTOX® Cosmetic (onabotulinumtoxinA)
Since BOTOX® Cosmetic was first approved by the U.S. Food and Drug Administration in 2002, Allergan has virtually changed the face of medical aesthetics. Healthcare providers can today provide science-based, minimally invasive medical aesthetic solutions to their patients with treatments like BOTOX® Cosmetic. BOTOX® Cosmetic was the first treatment of its kind FDA approved for the temporary improvement in the appearance of moderate to severe frown lines (between the brows) and today is the only FDA approved treatment for moderate to severe crow’s feet.
Wrinkles result from a combination of many factors. When you frown or concentrate, the muscles between your brows contract, causing your skin to furrow and fold. And when you squint, the muscles around your eyes contract and cause crow's feet.1
BOTOX® Cosmetic works beneath the skin's surface and targets the underlying muscle activity that helps cause frown lines and crow's feet to form over time. BOTOX® Cosmetic is a prescription medicine that works by blocking nerve impulses and reducing movement of the muscles around the eye area and in between the brows. The decreased muscle activity helps temporarily reduce the appearance of moderate to severe crow's feet lines and glabellar lines for noticeable results that do not radically change facial appearance. When administered by a properly trained healthcare professional, BOTOX® Cosmetic delivers noticeable, yet subtle results. Patients will not look like they have had work done and will still be able to maintain their facial expressions after treatment. Treatment is temporary, so patients should work with their physician to develop a treatment plan that is right for them.
BOTOX® Cosmetic is the number-one selling product of its kind in the world2. Ask your doctor if BOTOX® Cosmetic is right for you. To learn more about BOTOX® Cosmetic, visit www.BOTOXCosmetic.com.
BOTOX® Cosmetic (onabotulinumtoxinA) Important Information
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of both moderate to severe crow’s feet lines and frown lines between the eyebrows in adults.
IMPORTANT SAFETY INFORMATION
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic:
- Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several month
- Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities
The dose of BOTOX® Cosmetic is not the same as, or comparable to, any other botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines or both at the same time.
Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site.
Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Especially tell your doctor if you: have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin, such as Myobloc®, Dysport®, or Xeomin® in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
Please see BOTOX® Cosmetic full Product Information including Boxed Warning and Medication Guide.