Confidence comes from experience.

Only BOTOX® Cosmetic is FDA-approved to treat Glabellar Lines and Lateral Canthal Lines.

Since 2002, doctors have used BOTOX® Cosmetic to treat moderate to severe Glabellar Lines. Now BOTOX® Cosmetic is also FDA-approved to treat moderate to severe Lateral Canthal Lines.

How patients can verify they are receiving authentic BOTOX® Cosmetic.

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BOTOX® Cosmetic is only available from Allergan or an authorized supplier.

click here for a list of
authorized suppliers

How to administer

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BOTOX® Cosmetic in your practice.

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Authorized Suppliers of BOTOX® Cosmetic

AmerisourceBergen Corp.
ASD Healthcare
Burlington Drug Company
Cardinal Health
Clint Pharmaceuticals
Dakota Drug, Inc.
Dik Drug Company
DMS Pharmaceutical Group, Inc.
Florida Infusion/NationsDrug
Frank W Kerr Co.
H.D. Smith
Healthcare Device Solutions
Henry Schein, Inc.
Lifeline Pharmaceutical
McKesson Specialty Health
Miami-Luken, Inc.
Moore Medical LLC (H L MOORE)
Morris & Dickson Co., LLC
North Carolina Mutual Wholesale Drug Company
Physician Supply Company, Limited
PSS World Medical, Inc.
RDC, Inc.
Seacoast Medical
Smith Drug Company
Southern Anesthesia & Surgical Inc.
Superior Medical Supply, Inc.
The Harvard Drug Group LLC
TQM, Inc., DBA Two Rivers Medical
Value Drug Company
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There are a few easy steps you can take to ensure you are receiving authentic BOTOX® Cosmetic (onabotulinumtoxinA).

  1. See a reputable physician who purchases BOTOX® Cosmetic directly from Allergan or an authorized Allergan distributor. A list of physicians who purchase BOTOX® Cosmetic from Allergan is located on this website. Click here to search for a physician in your area.
  2. Request to see the package and vial of BOTOX® Cosmetic that the physician will use during your treatment.
    • Check the package for a U.S. license number on the carton.
    • The vial will have the “BOTOX® Cosmetic” logo and also have a hologram image that says Allergan.

Only BOTOX® Cosmetic from Allergan is:

  • FDA-approved to be sold and used in the United States. Products imported by foreign or unlicensed suppliers are not FDA approved and may be counterfeit or compromised.
  • Guaranteed for quality. When a U.S. physician purchases BOTOX® Cosmetic through Allergan or an Allergan authorized distributor, it is guaranteed for quality. BOTOX® Cosmetic is a biologic product and follows strict manufacturing, storage and transportation procedures that prevent the product from degradation.

If you suspect that you have been treated with BOTOX® Cosmetic that is not authentic or is compromised, report it to the FDA Office of Criminal Investigations by calling 1-800-551-3989 or visiting the FDA Web site (www.fda.gov/OCI).

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Only use BOTOX® Cosmetic provided by Allergan or an authorized distributer.

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How to verify you are receiving authentic BOTOX® Cosmetic.

BOTOX® Cosmetic Professional Important Information

BOTOX® Cosmetic (onabotulinumtoxinA) Important Information

Indication

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, INCLUDING BOXED WARNING

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 at lower doses.

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.

Injections In or Near Vulnerable Anatomic Structures

Care should be taken when injecting in or near vulnerable anatomic structures. Serious adverse events including fatal outcomes have been reported in patients who had received BOTOX® injected directly into salivary glands, the oro-lingual-pharyngeal region, esophagus and stomach. Safety and effectiveness have not been established for indications pertaining to these injection sites. Some patients had preexisting dysphagia or significant debility. Pneumothorax associated with injection procedure has been reported following the administration of BOTOX® near the thorax. Caution is warranted when injecting in proximity to the lung, particularly the apices.

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 junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of BOTOX® Cosmetic.

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 if Viral Disease

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 events following injection of BOTOX® Cosmetic ifor 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 serotypes 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.

For more information on BOTOX® Cosmetic, please see the accompanying full Prescribing Information including Boxed Warning and Medication Guide.

 

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1 Data on file, Allergan, Inc., Worldwide Neuromodulator Market Overview, Q3 2011.
©2013 Allergan, Inc. Irvine, CA 92612. ® marks owned by Allergan, Inc.
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registered in the US and other countries. 1-800-BOTOXMD


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