Why BOTOX® Cosmetic

Discover the science behind the one providers and patients trust1,2,*,†

*Based on a 2022 online survey of 251 neurotoxin patients. When asked which of the attributes they associate with BOTOX® Cosmetic, 84% (n = 235) stated that it “Is a brand I trust.”1

†Based on a 2022 online survey of 241 specialists. 87% of specialists rated “Is a brand I trust” as an important attribute and 55% associated that attribute with BOTOX® Cosmetic.2

The one and only neurotoxin that can provide simultaneous treatment in 3 areas3-7

Only BOTOX® Cosmetic is FDA approved for the temporary improvement in the appearance of
moderate to severe forehead lines, lateral canthal lines, and glabellar lines in adults.3-7

moderate to severe

Forehead Lines

moderate to severe

Lateral Canthal Lines

moderate to severe

Glabellar Lines

See clinical study results for simultaneous treatment

See Studies

The ONE with the most neurotoxin experience and a one-of-a-kind formulation3-13

ribbon

30+ years of experience ensuring quality product8,9

AbbVie owns end-to-end development from drug substance development to manufacturing and distribution and has been manufacturing BOTOX® (onabotulinumtoxinA) since its therapeutic approval in 19898,9

search

Most studied neurotoxin based on peer-reviewed publications10

Over 5200 publications featuring BOTOX® or BOTOX® Cosmetic10

tick

More FDA approvals than any other neurotoxin3-8

3 BOTOX® Cosmetic aesthetic uses and 12 BOTOX® therapeutic uses3,8

Approved in over 100 countries3,8,11

BOTOX® and BOTOX® Cosmetic are approved for over 30 therapeutic and aesthetic uses worldwide, with over 150 million vials distributed globally3,8,11,12

formulation

One-of-a-kind formulation

Unique manufacturing and formulation processes result in noninterchangeability among botulinum toxin products.3-7,13

The ONE with a history of aesthetic firsts

1989

1989

BOTOX® (onabotulinumtoxinA) becomes the first neurotoxin approved for therapeutic use for blepharospasm and strabismus8

vial

2002

2002

BOTOX® Cosmetic becomes the first neurotoxin approved for aesthetic use for moderate to severe glabellar lines3,14

forehead

2009

2009

Allergan creates the first aesthetic patient loyalty program—now known as Allē‡

‡Launched as Brilliant Distinctions® in 2009.

Alle Logo

2011

2011

BOTOX® and BOTOX® Cosmetic introduce the first-of-its-kind cell-based assay, reducing the need for animal testing15

2014

2014

BOTOX® Cosmetic is the first neurotoxin to be approved for moderate to severe lateral canthal lines3,14

eye
eye

2017

2017

BOTOX® Cosmetic is the first neurotoxin to be approved for moderate to severe forehead lines—making it the first and only neurotoxin to be approved for simultaneous use in 3 areas3,14

forehead

2019

2019

BOTOX® celebrates 30 years since initial approval8

2022

2022

BOTOX® Cosmetic celebrates 20 years since initial approval3,14

2023

2023

Celebrating the fifth year of BOTOX® Cosmetic Day

gold vial

& BEYOND

There’s only one BOTOX® Cosmetic

Order your BOTOX® Cosmetic product from Allergan Aesthetics or an authorized distributor—it’s the only way to ensure you have the genuine product that’s FDA approved and federally licensed in the US.

#SeetheVial—how to check for authentic BOTOX® Cosmetic product

Tamper-evident seal

Make sure that the tamper-evident seal is intact

Established name

Ensure that the established name “onabotulinumtoxinA” appears on the product box and vial

License number

Check for US license #1145 on the box and vial

Hologram

Look for the "ALLERGAN" hologram on the vial

Track & trace

Know that Allergan Aesthetics can verify authenticity and approval for sale in the US

Report suspicious products

Federal law prohibits non–FDA-approved drug importation. If you suspect unlawful importation from an unauthorized source, please report it to the authorities, tell your Allergan Aesthetics representative, or report it on the FDA website. If you have any questions about authenticity, please call the Allergan Aesthetics legal team at 1-714-246-4500.

Order BOTOX® Cosmetic now

Order Allergan Aesthetics products or manage your account on AllerganDirect.com

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Botox Cosmetic Vials
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Results

See the real results of patients treated with BOTOX® Cosmetic.

Learn More

Education

Train on reconstitution, assessment strategies, injection techniques, and more.

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Practice Support

Partner with Allergan Aesthetics to gain access to support and resources.

Learn More

REFERENCES: 1. Data on file, Allergan Aesthetics, February 2023; Consumer NTX A&U. 2. Data on file, Allergan Aesthetics, January 2023; HCP NTX A&U Report. 3. BOTOX® Cosmetic Prescribing Information, July 2020. 4. Dysport Prescribing Information, January 2023. 5. Xeomin Prescribing Information, August 2021. 6. Jeuveau Prescribing Information, January 2020. 7. Daxxify Prescribing Information, September 2022. 8. BOTOX® Prescribing Information, August 2022. 9. Data on file, Allergan Aesthetics, October 29, 2020; Westport Manufacturing Process. 10. Data on file, Allergan Aesthetics, March 2023; Botulinum Toxin Peer-Reviewed Publications. 11. Data on file, Allergan Aesthetics, January 2023; Worldwide Marketing Authorization Status. 12. Data on file, Allergan Aesthetics, December 5, 2022; Number of Total Vials Produced at Westport. 13. Brin MF, James C, Maltman J. Botulinum toxin type A products are not interchangeable: a review of the evidence. Biologics. 2014;8:227-241. 14. Data on file, Allergan Aesthetics; FDA Product Approval Information. 15. Allergan receives FDA approval for first-of-its-kind, fully in vitro, cell-based assay for BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA). News release. Allergan; June 24, 2011. Accessed June 30, 2023. https://www.businesswire.com/news/home/20110624005918/en.

BOTOX® Cosmetic (onabotulinumtoxinA) Important Safety Information, Including Boxed Warning

BOTOX® Cosmetic (onabotulinumtoxinA) 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 and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

Important Information

Indications

BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity

- Moderate to severe lateral canthal lines associated with orbicularis oculi activity

- Moderate to severe forehead lines associated with frontalis activity

IMPORTANT SAFETY INFORMATION (continued)
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), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

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.

Increased Risk of Clinically Significant Effects With 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).

Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.

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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).

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

The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).

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
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Please see accompanying BOTOX® Cosmetic full Prescribing Information, including Boxed Warning, or visit https://www.rxabbvie.com/pdf/botox-cosmetic_pi.pdf

BOTOX® Cosmetic (onabotulinumtoxinA) 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 and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.

Important Information

Indications

BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:

- Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity

- Moderate to severe lateral canthal lines associated with orbicularis oculi activity

- Moderate to severe forehead lines associated with frontalis activity

IMPORTANT SAFETY INFORMATION (continued)
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), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

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.

Increased Risk of Clinically Significant Effects With 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).

Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.

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 and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).

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

The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).

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
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.

Please see accompanying BOTOX® Cosmetic full Prescribing Information, including Boxed Warning, or visit https://www.rxabbvie.com/pdf/botox-cosmetic_pi.pdf

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