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JUVÉDERM® Ultra XC Indication and Important Safety Information


Indication

JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation 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 JUVÉDERM® Ultra XC 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: 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 specific sites in which an active inflammatory 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 who are knowledgeable about 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 moderate to severe facial wrinkles and folds, and lips and perioral area for

lip augmentation, have not been established in controlled clinical studies

• As with all transcutaneous procedures, dermal filler 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 under 18 years has not been established

• The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied

• Use with caution in patients on immunosuppressive therapy

• Patients who are using products that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased

bruising or bleeding at treatment sites

ADVERSE EVENTS

The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, discoloration,

and itching. Most side effects are mild or moderate in nature, lasting 14 days or less.

To report a problem with JUVÉDERM® Ultra XC, please call Allergan Product Surveillance at 1-800-624-4261.

For more information, please see JuvedermDFU.com or call the Allergan Medical Information line at 1-800-433-8871.

JUVÉDERM® Ultra XC injectable gel is available by prescription only.












































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