What is Toxin?

The treatment that uses the Toxin in its purified form for reducing the appearance of wrinkles is known as a Toxin cosmetic. As we age, the skin starts to lose its firmness and elasticity. As the aging process continues fine lines and wrinkles become noticeable resulting in skin folds and creases.

Frown lines between the eyebrows can make you look angry, tired or unhappy; in such cases Toxin cosmetic is very useful. Toxin treatment has been used by doctors for many years. It helps in reducing wrinkles by plumping up the tissues and decreases the activity of facial muscles that produce the wrinkles. To get rid of aging lines or eliminate skin wrinkles and fine lines on your facial skin the Toxin is used in the form of injection. It only a few minutes to inject by a skilled provider. Toxin cosmetic is a simple procedure performed on an office visit. Toxin cosmetic reduces the appearance of fine lines and wrinkles giving a natural appearance. Toxin cosmetic administered properly by a skilled provider is safe and effective.

During Toxin cosmetic treatment, you may slightly feel discomfort due to tiny needles. This discomfort will disappear after treatment is completed. After Toxin cosmetic treatment, the muscles are relaxed and the wrinkle becomes smooth giving you fresh, young and glowing look on skin with full effect expressed at 14 days.

How Do Toxin injections work?

Toxins Cosmetic is an injectable treatment that reduces the appearance of fine lines and wrinkles. It has powerful muscle-relaxing abilities.

Toxins Cosmetic contains a substance that works beneath the skin’s surface. Toxins inhibit the signals from the nerves to the muscles. The injected muscle cannot contract, causing fine lines and wrinkles to be reduced. Toxins are frequently utilized on forehead lines, crow’s feet (lines around the eyes), and frown lines. The sun and gravity can cause wrinkles, but toxins are not a filler.

Toxins Cosmetic is injected with a fine needle into specific muscles with minor discomfort. Toxins Cosmetic generally takes 7 to 14 days to show full results. You should abstain from alcohol one to two weeks before the procedure and avoid NSAIDs 7-10 days prior to the procedure.

Is Toxin Treatment Painful?

Topical analgesics can be applied prior to a toxin treatment to make the procedure more comfortable. Without topical analgesics, the discomfort is minimal.

Each toxin session involves a few small injections. The amount of toxin used is dictated by the area to be treated, as some areas require more toxin than others. The level of discomfort depends on the patient’s pain tolerance.

The injection treatment itself takes about 10 minutes and can easily be scheduled during a lunch hour with little to no downtime. After a quick session, it is possible to return to daily activities, confident in the knowledge that you have cared for yourself with a little well-deserved pampering.

How Long Do Toxin Injections Last?

Toxins Cosmetic is an injectable treatment that reduces the appearance of fine lines and wrinkles. In general, toxin injections can last from 3 to 6 months per treatment. Depending on the patient’s individual activity, the toxin can be metabolized at different rates, shortening or lengthening its effects. Toxins have many medical uses, such as treating migraines, reducing neck spasms, and reducing contractures.

Several factors will affect how long Toxins Cosmetic will last, including:

• Your age

• The elasticity of your skin

• Wrinkle depth

• Other factors

For example, if you’re using Toxin to reduce the appearance of deep wrinkles, the wrinkles will not fully disappear, and the effects may wear off quicker.

How Often Should You Get Toxin Injections?

While Toxin will quickly block nerve communication, the results are not permanent. As the effects of Toxins Cosmetic wear off, you’ll begin to notice the fine lines and wrinkles returning. However, with regular treatment, these fine lines and wrinkles can diminish.

Toxin treatment is administered in units of the toxin. If less toxin is injected into an area that requires more units, results and effects will diminish quicker. During your visit to a skilled provider, they will determine the amount of units required for each area.

Are There Any Risks or Side Effects?

Toxins Cosmetic injections are relatively safe. Minor side effects are possible, including pain at the injection site, infection, inflammation, swelling, redness, bleeding, and bruising.

Symptoms that indicate an allergic reaction include itching, wheezing, asthma, a rash, red welts, dizziness, and faintness. Dry mouth, fatigue, headache, and neck pain have also been reported. Let your doctor know immediately if you experience any breathing issues or feel faint or dizzy.

Who Should Not Receive Toxins? Or Are You a Good Candidate for Toxins?

Toxins Cosmetic has been approved by the United States FDA for people aged 18 to 65. However, avoid using it if you are allergic to any ingredients in Toxins or Toxins Cosmetic.

• Have a skin problem or other condition in the application area

• Have any disease that can affect your muscles or nerves, such as ALS (Lou Gehrig’s disease), myasthenia gravis, or Eaton-Lambert syndrome

• Have breathing problems, such as asthma

• Have difficulty swallowing

• Have bleeding issues

• Plan to undergo surgery

• Have had facial surgery

• Have weakness in your forehead muscles

• Have drooping eyelids

• Are planning to conceive a child, are pregnant, are planning to breastfeed, or are currently breastfeeding. It’s better to be safe, and you can always have Toxins at a later date.

Indications, Important Safety Information, and Prescribing Information

Toxins Cosmetic (Purer Toxin) Important Information

Indications

Toxins Cosmetic (Purer Toxin) 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 Toxins Cosmetic and all toxin products may spread from the area of injection to produce symptoms consistent with 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.

CONTRAINDICATIONS

Toxins Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any toxin preparation or any of the components in the formulation.

WARNINGS AND PRECAUTIONS

Lack of Interchangeability Between Toxin Products

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

Spread of Toxin Effect

Please refer to the 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 Toxins 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 Toxins injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to the distant spread of the toxin but may have resulted from the administration of Toxins to the site of injection and/or adjacent structures. In several 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 Toxins. The safety and effectiveness of Toxins 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 Toxins 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 the administration of Toxins 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 (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given 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 Purer Toxin (see Warnings and Precautions).

Dysphagia and Breathing Difficulties

Treatment with Toxins and other 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 Toxins 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 Toxins Cosmetic

There have been reports of dry eye associated with Toxins Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (e.g., 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 the transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for the transmission of Creutzfeldt-Jakob disease (CJD), but if that risk 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 Toxins 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 Toxins Cosmetic for lateral canthal lines was eyelid edema (1%).

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

DRUG INTERACTIONS

Co-administration of Toxins Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., 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 Toxins Cosmetic may potentiate systemic anticholinergic effects.

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

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

USE IN SPECIFIC POPULATIONS

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

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