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Important Safety Information

INDICATIONS: Sculptra Aesthetic (injectable poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which the deep dermis layer is treated. CONTRAINDICATIONS: Known hypersensitivity to any component of the product; active skin inflammation or infection in treatment area; do not inject into blood vessels. WARNINGS: Use only by licensed practitioners trained in injectable techniques. Sculptra should not be used to augment the lips or used in the peri-orbital area. Visible skin nodules possible with or without inflammation or discoloration; may be permanent. Risk of infection as with all injectable procedures. ADVERSE EVENTS: Injection-site bruising, hemorrhage, erythema, pain, edema, and subcutaneous papules; most resolve within days to weeks. Post-injection nodules may occur.

References: 1. Sculptra Aesthetic prescribing information. 2. Phase III Clinical Trial, N=236, 24 months. 3. Multi-Center Outcomes Trial, Sculptra Aesthetic.