Botox® Cosmetic

Home

Botox® Cosmetic

A one-of-a-kind formulation,
BOTOX® Cosmetic (onabotulinumtoxinA) is the first and only FDA-approved treatment for adults to temporarily smooth moderate to severe crow’s feet, forehead lines and frown lines.

You’ve probably heard of BOTOX® Cosmetic, but did you know:

  • It’s the first and only FDA-approved treatment to temporarily smooth moderate to severe forehead lines, crow’s feet lines, and frown lines in adults
  • BOTOX® Cosmetic is a one-of-a-kind formulation—there’s nothing exactly like it
  • It delivers predictable, subtle results, so you look like you

So, if you’re bothered by those deepening lines and have thought about treatment to temporarily reduce them, ask for BOTOX® Cosmetic by name. And remember, when BOTOX® Cosmetic is administered correctly, you’ll still look like you after treatment.


FOREHEAD LINES | CROW’S FEET LINES | FROWN LINES

Minimum Downtime

A quick, 10-minute treatment that’s easy to fit into your busy schedule. Get in, get out, and on with your day.

 

Feels Like a Pinch

Ice or a topical numbing agent may be used to enhance your comfort

 

Real Noticeable Results

You may begin to see results within 24-48 hours, after treatment with Botox® Cosmetic.

 

How Does Treatment Work?

BOTOX® contain portions of botulinum toxin, which works as a block, reducing activity in the tiny muscles that allow us to laugh, frown or make other faces. After injections, these muscles do not move, thus reducing wrinkles and softening the entire complexion. Friends, family and co-workers may comment that you look well rested after BOTOX® treatment, not so angry or “tired”. Effects last on average 3-4 months.

 

What to Expect

BOTOX®, is injected into the areas of concern taking 10-15 minutes on average. Results begin to be seen in 3-7 days. Allow 2-3 weeks for full effect.

 

Free consultations are available for all cosmetic injectables, facial rejuvenation treatments and customized facials. During each initial no cost consultation, we do a comprehensive assessment to determine which treatment options would be appropriate for your skin, your budget and your personal goals.

BTXC-color

BOTOX® Cosmetic (onabotulinumtoxinA) 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, 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 spasticity 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), 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.

 

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).

 

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 reaction following injection of BOTOX® Cosmetic for glabellar lines was eyelid ptosis (3%).

 

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 BOTOX® Cosmetic Full Prescribing Information including Boxed Warning and Medication Guide. 

BCT110283 10/17