BELOTERO BALANCE® SAFETY INFORMATION (from www.belotero.com)
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).
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.
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
RADIESSE® VOLUMIZING FILLER SAFETY INFORMATION (from www.radiesse.com)
Indication: RADIESSE® Volumizing Filler is FDA-approved for subdermal implantation for the correction
of moderate to severe facial wrinkles and folds, such as nasolabial folds.
Contraindications: RADIESSE® Volumizing Filler should not be used in patients with bleeding disorders
or in patients with severe allergies manifested by a history of anaphylaxis, with a history or presence of
multiple severe allergies or with a history of hypersensitivity to the components of RADIESSE ®
Volumizing Filler.
Warnings: RADIESSE® Volumizing Filler should not be injected into blood vessels. Use of RADIESSE®
Volumizing Filler in any person with active skin inflammation or infection in or near the treatment area
should be deferred until the inflammatory or infectious process has been controlled. The safety and
effectiveness for use in the lips has not been established. There have been published reports of nodules
associated with the use of RADIESSE® Volumizing Filler injected into the lips.
Precautions: Safety for use during pregnancy, in breastfeeding females or in patients under 18 years
has not been established. As with all skin-injection procedures, there is a risk of infection. Patients using
medications that prolong bleeding, such as aspirin or warfarin, may, as with any injection procedure,
experience increased bruising and bleeding at the injection site. Patients should inform their physician if
they are using such medications. Patients should minimize exposure of the treated area to extensive sun
or heat exposure for approximately 24 hours after treatment or until any initial swelling and redness has
resolved. Safety and effectiveness in the periorbital area has not been established. The safety of
RADIESSE® Volumizing Filler in patients with a susceptibility to keloid formation and hypertrophic
scarring has not been studied. Patients with a history of previous herpetic eruption may experience
reactivation of the herpes.
Adverse Events: After injection, patients may experience redness, bruising, swelling or other local side
effects. Most side effects of treatment resolve within a few days. More rare side effects may include
swelling that lasts longer, unevenness or firmness in the area injected.
Important: For full safety information, please visit www.radiesse.com or call Merz Aesthetics Customer
Service at 866-862-1211
Caution: Rx Only
XEOMIN® SAFETY INFORMATION (from www.xeominaesthetic.com)
INDICATIONS AND USAGE
XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use, is a prescription medication that is
injected into facial muscles for the temporary improvement in the appearance of moderate to severe
glabellar lines (frown lines) in adult patients.
XEOMIN® should be administered no more frequently than every three months.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use, and all botulinum toxin
products may spread from the area of injection and produce effects that include loss of strength, muscle
weakness all over the body, double vision, blurred vision, drooping eyelids, trouble swallowing,
hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, and trouble
breathing. 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, particularly in those
patients who have underlying conditions that would predispose them to these symptoms. Cases in which
the effect has spread have occurred both at the doses used for the treatment of neck spasticity and
disorders of muscle tone and at lower doses.
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 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.
Headache was the most common side effect of XEOMIN® for treatment of glabellar lines. Other
side effects of XEOMIN® include: dry mouth, discomfort or pain at the injection site, tiredness, 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.