JUVÉDERM® VOLUMA® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC Important Information
APPROVED USES
JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds.
JUVÉDERM® Ultra XC injectable gel is for injection into the lips and perioral area for lip augmentation in adults over 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® injectable gel formulation?
Do not use these products 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 these products.
What precautions should my doctor advise me about?
• Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not
been studied
• The safety of JUVÉDERM® VOLUMA® XC in patients under 35 years or over 65 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels in patients under 18 years, has not been studied
• The safety and effectiveness of JUVÉDERM® VOLUMA® XC in areas other than the cheek area, JUVÉDERM® Ultra Plus XC and JUVÉDERM®
Ultra XC in areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC in areas other than the lips and perioral area for lip augmentation have not been established in clinical studies
• Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM® products has not been studied in these patients and 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 inflammation at the treatment site if these procedures are performed after treatment 

• Patients who experience skin injury near the site of injection with these products may be at a higher risk for adverse events
• Tell your doctor if you are on therapy used to decrease the body’s immune response (immunosuppressive therapy). Use may result in an increased risk of infection
• Tell your doctor before treatment if you are using substances that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners.
As with any injection, 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® injectable gels included injection-site tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. For JUVÉDERM® VOLUMA® XC, most side effects were moderate and lasted 2 to 4 weeks. For JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels, most side effects were mild or moderate and lasted 14 days or less.
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.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871. Please visit Juvederm.com or talk to your doctor for more information.
Available by prescription only.