JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC
The JUVÉDERM® family of hyaluronic acid dermal fillers provides a smooth, long-lasting correction of moderate to severe facial wrinkles and folds.
JUVÉDERM® is the first smooth consistency gel formulation and only hyaluronic acid dermal filler approved by the FDA to last up to one year from initial treatment.1 JUVÉDERM® is developed using the proprietary HYLACROSS™ technology, an advanced manufacturing process that results in a malleable, smooth gel that flows easily and consistently into the skin and provides a predictable result. All other hyaluronic acid dermal fillers currently on the market have a granular consistency gel. These granules can be seen under 2.4x magnification as opposed to the smooth consistency gel of the JUVÉDERM® dermal fillers.
In 2010, the FDA approved JUVÉDERM® XC formulated with the local anesthetic lidocaine to provide patients with a more comfortable injection experience when compared to the non-lidocaine formulation, and potentially less time spent in the physician’s office. JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC contain 0.3% preservative-free lidocaine and numb the treatment area within seconds, potentially reducing the need for an additional anesthetic. JUVÉDERM® XC products provide the same smooth, long-lasting results as demonstrated with existing JUVÉDERM® products.
To provide physicians with the flexibility to tailor each treatment to the specific needs of the patient, the JUVÉDERM® family of dermal fillers include JUVÉDERM® Ultra and JUVÉDERM® Ultra XC with lidocaine, highly cross-linked formulations for more versatility in contouring and volumizing of facial wrinkles and folds; and JUVÉDERM® Ultra Plus and JUVÉDERM® Ultra Plus XC with lidocaine, more highly cross-linked robust formulations for volumizing and correction of deeper folds and wrinkles.
Ask your doctor if JUVÉDERM® is right for you.
A Brief Description of Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events for JUVÉDERM® Injectable Gel
Indication: In the United States, JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Contraindications: JUVÉDERM® injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies. JUVÉDERM® should not be used in patients with a history of allergies to Gram-positive bacterial proteins. JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.
Warnings: JUVÉDERM® injectable gel should not be injected into blood vessels. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.
Precautions: The safety of JUVÉDERM® for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established. The safety and effectiveness of JUVÉDERM® injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies. Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at injection site. Patients should inform their physician before treatment if they are using these types of substances. As with all skin-injection procedures, there is a risk of infection. JUVÉDERM® should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body’s immune response, as there may be an increased risk of infection. The safety of JUVÉDERM® in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied. If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment with JUVÉDERM® injectable gel, or if JUVÉDERM® is administered before the skin has healed completely after such a procedure, there is a possible risk of an inflammatory reaction at the treatment site.
Adverse events: The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, and bruising. Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less).
Important: For full safety information, please visit www.juvederm.com or call Allergan Product Support at 1-877-345-5372.
CAUTION: Rx only.