Please scroll for XEOMIN® (incobotulinumtoxinA) Important Safety Information including Boxed Warning, full Prescribing Information and Medication Guide.
XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION
Read the Medication Guide before you start receiving XEOMIN (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive.
To learn more:
- Talk to your health care provider or pharmacist
- Visit www.xeominaesthetic.com to obtain the FDA-approved product labeling
- Call 1-866-862-1211
Uses: XEOMIN is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults for a short period of time (temporary). It is not known if XEOMIN is safe and effective in children under 18 years of age. Please see additional Important Safety Information below and Full Prescribing Information and Medication Guide at XeominAesthetic.com.
Warnings: XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:
- Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
- People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
- Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
- Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, 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.
These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.
Do not use XEOMIN if you are allergic to XEOMIN or any of the ingredients in XEOMIN (see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin products such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC), or abobotulinumtoxinA (DYSPORT®) or have a skin infection at the planned injection site.
Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:
- have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome)
- have had any side effect from any other botulinum toxin in the past
- have a breathing problem such as asthma or emphysema
- have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
- have bleeding problems
- have drooping eyelids
- have plans to have surgery
- have had surgery on your face
- are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.
Using XEOMIN 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 XEOMIN in the past. Especially tell your doctor if you
- have received any other botulinum toxin product in the last four months
- have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.
- have recently received an antibiotic by injection
- take muscle relaxants
- take an allergy or cold medicine
- take a sleep medicine
Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
Possible Side Effects
XEOMIN can cause serious side effects that can be life threatening including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint. See “Warnings.”
The most common side effect of XEOMIN in people with frown lines include:
These are not all the possible side effects of XEOMIN. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of XEOMIN
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.
Active Ingredient: botulinum toxin type A
Inactive Ingredients: human albumin and sucrose
IMPORTANT RADIESSE® and RADIESSE® (+) SAFETY INFORMATION
RADIESSE® and RADIESSE® (+) are dermal fillers that are used for smoothing moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of your nose to the corner of your mouth). RADIESSE® is also used for correcting volume loss in the back of the hand. RADIESSE® (+) is also used for improving moderate to severe loss of jawline contour in adults over 21 years old.
The most common adverse events seen in clinical studies of RADIESSE® or RADIESSE® (+) used in the face include bruising, redness, swelling, pain, itching, difficulty chewing, and other local side effects. The most common adverse events seen in clinical studies of RADIESSE® used in the hands include bruising, redness, swelling, pain, itching, nodules or bumps/lumps, difficulty performing activities, loss of sensation and other local side effects.
These are not all the possible side effects with RADIESSE® and RADIESSE® (+). For full RADIESSE® and RADIESSE® (+) safety information, including adverse events collected outside clinical studies, please view the RADIESSE® and RADIESSE® (+) Patient Information Guides available at www.Radiesse.com or from MyMerz Solutions at 1-844-469-6379.
BELOTERO BALANCE® is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds.
BELOTERO IMPORTANT SAFETY INFORMATION
BELOTERO BALANCE® should not be used in patients with a history of or presence of multiple or severe allergies, including those with a history of anaphylaxis. BELOTERO BALANCE® should not be used in patients with allergies to gram-positive bacterial proteins.
If BELOTERO BALANCE® is injected into a blood vessel, serious complications can result including stroke, vision abnormalities, blindness, temporary scabs and permanent scars. Use of BELOTERO BALANCE® in any person with active skin inflammation or infection in or near the treatment should be deferred until the inflammatory or infectious process is controlled.
The most common adverse events seen in clinical studies with BELOTERO BALANCE® were swelling, bruising, redness, hardening of the skin, pain, altered color or itching. Side effects were often mild to moderate and often resolved within 7 days. These are not all the possible side effects with BELOTERO BALANCE®.
Information on adverse events from post-market surveillance of BELOTORO BALANCE® are included in the Package Insert (PI) and Patient Information Guide (PIG) based on an assessment of seriousness and potential causal relationship to BELOTERO BALANCE®. Please see the PI and PIG available on www.belotero.com for a complete list of these events.
For full BELOTERO BALANCE® safety information, please visit www.belotero.com, or call MyMerz Solutions at 1-844-469-6379.
BELOTERO BALANCE® is available by prescription only.
Ulthera® SYSTEM Important Safety Information
The non-invasive Ultherapy® procedure is U.S. FDA-cleared to lift skin on the neck, on the eyebrow and under the chin as well as to improve lines and wrinkles on the décolleté. The CE Mark indications for use for the Ulthera® System include non-invasive dermatological sculpting and lifting of the dermis on the upper face, lower face, neck and décolleté.
Reported adverse events from post-marketing surveillance are available in the Instructions for Use (IFU).
Please see the available IFU in your country for product and safety information, including a full list of these events. For ULTHERAPY® safety information, visit www.Ultherapy.com/IFU
THE SALTFACIAL® IMPORTANT SAFETY INFORMATION
The F.D.A. indication for use with regards to: The SaltFacial Aesthetic Ultrasound module indication for use is: Ultrasound Diathermy For Use In Applying Therapeutic Deep Heat. The F.D.A. indication for use with regards to:The SaltFacial Blue light mode of The L.E.D. Phototherapy module indication for use is: For dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.