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JUVÉDERM VOLLURE TM XC Indication and Important Safety Information
JUVÉDERM VOLLURE TM XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS
This product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.

WARNINGS
• Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue llers; 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 llers 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: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
• Product use at speci c sites in which an active in ammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled PRECAUTIONS
• In order to minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and knowledge of facial anatomy • Healthcare professionals are encouraged to discuss the potential risks of soft-tissue injections with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications
• The safety and effectiveness for the treatment of anatomic regions other than facial wrinkles and folds with JUVÉDERM VOLLURETM XC have not been established in controlled clinical studies
• As with all transcutaneous procedures, dermal ller implantation carries a risk of infection. Follow standard precautions associated with injectable materials
• The safety for use during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
• The safety for use of JUVÉDERM VOLLURE TM XC in patients under 22 years has not been established
• Use with caution in patients on immunosuppressive therapy
• Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-in ammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
• If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or if the product is administered before the skin has healed completely, there is a possible risk of an in ammatory reaction at the treatment site
• Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
• Patients may experience late onset adverse events with use of dermal llers

**ADVERSE EVENTS **
The most commonly reported side effects for JUVÉDERM VOLLURE TM XC injectable gel were injection-site redness, swelling, pain, tenderness, rmness, lumps/ bumps, bruising, discoloration, and itching. Side effects were mostly mild or moderate in severity, with duration of 14 days or less. To report an adverse reaction with JUVÉDERM VOLLURETM XC, please call Allergan at 1-800-433-8871. Please visit JuvedermDFU.com for more information. JUVÉDERM VOLLURE TM XC injectable gel is available by prescription only.

APPROVED USES

JUVÉDERM VOLLURE TM XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, in adults over 21.

**IMPORTANT SAFETY INFORMATION **
Are there any reasons why I should not receive JUVÉDERM VOLLURE TM XC injectable gel?
Do not use this product if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in this product.

What precautions should my doctor advise me about?
• Tell your doctor if you are pregnant or breastfeeding. The safety of this product for use during pregnancy or while breastfeeding has not been studied
• The safety of JUVÉDERM VOLLURE TM XC in patients under 22 years has not been studied
• The safety and effectiveness of JUVÉDERM VOLLURE TM XC in areas other than facial wrinkles and folds have not been established in clinical studies
• Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of this product may result in additional scars or changes in pigmentation
• Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of in ammation at the treatment site if these procedures are performed after treatment
• Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects
• Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of this product may result in an increased risk of infection
• Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may result in increased bruising or bleeding at the injection site
• Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment

**What are possible side effects?
** The most commonly reported side effects with JUVÉDERM VOLLURE TM XC injectable gel included injection- site redness, swelling, pain, tenderness, rmness, lumps/bumps, bruising, discoloration, and itching. Most side effects were mild or moderate and lasted 14 days or less. One of the risks with using this product is unintentional injection into a blood vessel, and, while rare, 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.

As with all skin injection procedures, there is a risk of infection. To report a side effect with JUVÉDERM VOLLURE TM XC please call Allergan at 1-800-433-8871. Please visit Juvederm.com or talk to your doctor for more information.

Available by prescription only.