SOFTEN YOUR LINES, NOT YOUR EDGE

BOTOX® Cosmetic—the only FDA-approved product that temporarily improves
both moderate to severe crow’s feet AND frown lines between the brows in adults.

FACTS YOU SHOULD KNOW

BOTOX® Cosmetic helps smooth moderate to severe crow’s feet and frown lines
by targeting one of the underlying causes—the muscle contractions responsible for frowning and squinting.

TOP MYTHS ABOUT BOTOX® COSMETIC

MYTH #1 – BOTOX® Cosmetic will make you look like you’ve had work done

BOTOX® Cosmetic subtly smoothes the moderate to severe lines around your eyes and between your brows. No one needs to know—you’ll still look like you.

WHAT TO EXPECT

A TYPICAL VISIT: IN THE OFFICE

  CONSULTATION
Discuss any concerns you have and ask your specialist questions.

 

  ASSESSMENT
Your specialist will do a facial analysis to figure out the best treatment plan for you.

 

  TREATMENT
If appropriate, your specialist will inject you with BOTOX® Cosmetic. The actual treatment takes about 10 minutes—get in, get out, get on with your day.

 

  FOLLOW-UP
Check out and schedule your next appointment. Call your specialist if you have any additional questions.

 

RESULTS: AFTER TREATMENT

  24 TO 48 HOURS
You may begin to notice results within 24 to 48 hours for moderate to severe frown lines.

 

  UP TO 4 MONTHS

Results have been proven to last up to 4 months in clinical trials for moderate to severe frown lines.

  • Physician-reported response of 25% (102/403) vs 2% (2/128) for placebo

TOP 5 MYTHS ABOUT BOTOX® COSMETIC

MYTH #1 – BOTOX® Cosmetic will make you look like you’ve had work done

BOTOX® Cosmetic subtly smoothes the moderate to severe lines around your eyes and between your brows. No one needs to know—you’ll still look like you.

MYTH #2 – BOTOX® Cosmetic takes too much time out of your day

BOTOX® Cosmetic can work with busy schedules. Treatment takes about 10 minutes and requires minimal down time or recovery.

MYTH #3BOTOX® Cosmetic is only for women

Nope, think again. BOTOX® Cosmetic is FDA approved to treat all appropriate adults. In clinical studies for moderate to severe frown lines and crow’s feet, 17.5% and about 12%, respectively, of patients treated with BOTOX®Cosmetic were men. Ask your specialist if BOTOX® Cosmetic is right for you.

MYTH #4 – BOTOX® Cosmetic is new and untested

Not true. In 2002, BOTOX® Cosmetic became the first FDA-approved product to temporarily improve moderate to severe frown lines. And in 2013, it became the first and only FDA-approved product to temporarily improve moderate to severe crow’s feet.

Plus, it’s one of the most widely studied and researched medical aesthetic products.

MYTH #5 – BOTOX® Cosmetic is for your lips

It’s definitely not approved for use in lips. BOTOX® Cosmetic is approved to be injected around the sides of your eyes (for treatment of crow’s feet) or between your brows (for treatment of frown lines).

WHAT IT IS

BOTOX® COSMETIC IS AN INJECTION

Your specialist injects it into your muscles around the sides of your eyes (crow’s feet) and between your brows (frown lines).

BOTOX® COSMETIC TEMPORARILY REDUCES MUSCLE ACTIVITY

BOTOX® Cosmetic helps smooth moderate to severe crow’s feet and frown lines by targeting one of the underlying causes—the muscle contractions responsible for frowning and squinting.

WHAT IT’S MADE FROM

BOTOX® Cosmetic is made from sources that exist in nature. It contains tiny amounts of a highly purified protein refined from the bacterium, Clostridium botulinum.

APPROVED USES
Approved Uses
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. 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 months
  • 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

BOTOX® Cosmetic dosing units are 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.

BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. 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 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: 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 (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.

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 (tell your doctor 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: discomfort or pain at the injection site; headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of your eyelids.

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.

WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and upper limb spasticity and at lower doses.
INDICATIONS
Indications
Glabellar Lines
BOTOX® Cosmetic (onabotulinumtoxinA) for injection is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.

Lateral Canthal Lines
BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS AND PRECAUTIONS
Lack of Interchangeability between Botulinum Toxin Products

The potency Units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.

No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines) have been reported.

Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.

Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.

Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).

Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).

Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).

Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

ADVERSE REACTIONS
The most frequently reported adverse event following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).

The most frequently reported adverse event following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).

DRUG INTERACTIONS
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX®Cosmetic may potentiate systemic anticholinergic effects.

The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.

USE IN SPECIFIC POPULATIONS
BOTOX® Cosmetic is not recommended for use in children or pregnant women. It is not known whether BOTOX® Cosmetic is excreted in human milk. Caution should be exercised when BOTOX® Cosmetic is administered to a nursing woman.

Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.

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