RADIESSE® and RADIESSE® (+) IMPORTANT SAFETY INFORMATION

Who should not use RADIESSE® or RADIESSE® (+)?
You should not use RADIESSE® or RADIESSE® (+) if you have an allergy to any component of the product, if you have a history of severe allergies, if you have a bleeding disorder, or if you are pregnant or breastfeeding. You should not use RADIESSE® (+) if you have an allergy to lidocaine or medicines like it.

What is the most important information I should know about RADIESSE® and RADIESSE® (+)?
One of the risks with using these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious, and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.

As with all procedures that involve an injection through the skin, there is a risk of infection.

Do not use RADIESSE® or RADIESSE® (+) if you have a skin infection until it has healed.

It is not known if RADIESSE® or RADIESSE® (+) is safe or effective in the lips, or in the area around the eyes.

The microspheres in RADIESSE® and RADIESSE® (+) can be seen in X-rays and CT Scans. It is very important that you tell your health care provider that you have had RADIESSE® or RADIESSE® (+) dermal filler.

If you have a history of herpes, you may experience a herpes breakout after receiving RADIESSE® or RADIESSE® (+).

Injection in the back of the hand may result in temporary difficulty performing activities. RADIESSE® may cause nodules, bumps or lumps in the back of the hand and can last up to 1 year.

You should minimize strenuous activity and avoid extensive sun or heat exposure for about 24 hours after treatment and until any swelling or redness has resolved.

What should I tell my doctor before using RADIESSE® or RADIESSE® (+)?
Tell your health care provider if you are taking blood thinners or medicines that can interfere with the clotting of blood, such as aspirin or warfarin. These medicines might make it more likely that you will experience bruising or bleeding at the injection site. Tell your health care provider if you have any diseases, injuries or disabilities of the hand, if you have a history forming large, raised scars or if you have had any other skin treatments such as skin peels.

What are the most common adverse events with RADIESSE® or RADIESSE® (+)?
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. The most common adverse events seen in clinical studies of RADIESSE® or RADIESSE® (+) used in the face include bruising, redness, swelling, pain, itching and other local side effects.

These are not all of the possible side effects with RADIESSE® or RADIESSE® (+). Merz collects information about adverse events seen with RADIESSE® and RADIESSE® (+) outside of clinical studies. These events are included in the RADIESSE® and RADIESSE® (+) Patient Information Guide based on an assessment of seriousness and potential causal relationship to RADIESSE® or RADIESSE® (+). Please see the Patient Information Guide available at www.Radiesse.com for list of these events. Tell your health care provider about any side effects that bother you or do not go away.

Important: For full safety information, please visit www.Radiesse.com or call Merz Aesthetics Customer Service at 866-862-1211

RADIESSE® and RADIESSE® (+) are available by prescription only.

What is BELOTERO BALANCE?
BELOTERO BALANCE® is a prescription injection that is approved to temporarily
smooth out and fill in moderate to- severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).

IMPORTANT SAFETY INFORMATION FOR BELOTERO BALANCE®

Who should not use BELOTERO BALANCE?

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.

What is the most important information I should know about BELOTERO BALANCE?
As with all events that involve an injection through the skin, there is a risk of infection. Laser treatments or chemical peels or any other treatments that affect the skin can increase the risk of infection. Do not use BELOTERO BALANCE if you have a skin inflammation or a skin infection. Do not use until the infection is healed.

Patients getting BELOTERO BALANCE may have an injection site reaction. These reactions can include inflammation and usually last less than seven days.
For approximately 24 hours after treatment, avoid:
• strenuous activity
• extensive sun or heat exposure
• aspirin or non-steroidal anti-inflammatory drugs
• alcoholic beverages
Exposure to any of the above can cause temporary redness, swelling, and/or itching at the injection site.

Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke,
skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in
vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after
the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur. ‘

It is not known how BELOTERO BALANCE will work in areas of the face other than the smile lines. It is not known how BELOTERO BALANCE will work in women who are pregnant or breastfeeding or people who are less than 21 years of age.

What should I tell my doctor before injections with BELOTERO BALANCE?

Tell your doctor if you are taking medicines that affect blood clotting, like aspirin, an
NSAID or warfarin.
These medicines may put you at an increased risk of bruising or bleeding at the treatment site.

Tell your doctor if you have a skin reaction like cold sores, cysts, pimples, rashes, hives, or an infection.

Treatment with BELOTERO BALANCE should be delayed until the reaction goes away. Tell your doctor if you are taking medicines that affect your immune system.
What are the most common adverse events seen with BELOTERO BALANCE? The most common local side effects seen with BELOTERO BALANCE were swelling, bruising, redness, hardening of the skin, pain, altered color, or itching. Other side effects that have occurred with BELOTERO BALANCE include headache, swelling of the side of the nose, moderate cold sore, lip numbness, and lip dryness. Side effects were often mild to moderate and often resolved within 7 days.

Important: For full safety information and Instructions for Use, please visit www.belotero.com or call Merz Aesthetics Customer Service at 866-862-1211.

Caution: Rx Only

INDICATION

XEOMIN® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults.

IMPORTANT SAFETY INFORMATION

XEOMIN® (incobotulinumtoxinA) 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 any time (hours to weeks) after treatment with XEOMIN:

• Problems with swallowing, speaking, or breathing can happen after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. If these problems are severe, you could die. 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.

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN; had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport®); have a skin infection at the planned injection site.

Before you take XEOMIN, tell your doctor about all 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), as you may be at increased risk of serious side effects including difficulty swallowing or breathing. Tell your doctor if you have: had any side effect from any other botulinum toxin in the past; breathing problems such as asthma or emphysema; a history of swallowing problems or inhaling food or fluid into your lungs (aspiration); bleeding problems; drooping eyelids; plans to have surgery; had surgery on your face.  Also tell your doctor if you 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 the medicines you take, including prescription and nonprescription medicines, vitamins and herbal products. 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 or 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. Tell your doctor if you: have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take a blood thinner medicine.

XEOMIN may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking XEOMIN. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

XEOMIN may cause other serious side effects 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.

Other side effects of XEOMIN include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, muscle weakness, and eye problems, including double vision, blurred vision, drooping eyelids, swelling of your eyelids, and dry eyes. Reduced blinking can also occur. Tell your doctor or get medical help right away if you have eye pain or irritation following treatment.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of XEOMIN. For more information, ask your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.