Instructions for Use

Safety information and patient resources

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Restylane Instructions for Use

Perlane® Instructions for Use

Restylane Patient Labeling

Perlane Patient Labeling

Please see below for Important Safety Considerations for the Restylane family of products.

Important Safety Information

The Restylane family of products includes Restylane®, Restylane-L®, Perlane®, and Perlane-L®. These products are indicated for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. Restylane and Restylane-L are indicated for mid-to-deep dermal implantation; Perlane and Perlane-L are indicated for implantation into the deep dermis to superficial subcutis. Restylane and Restylane-L are also indicated for submucosal implantation for lip augmentation in patients over 21 years.

Important Safety Information for the Restylane family of products
Products in the Restylane family contain traces of gram-positive bacterial protein and are contraindicated for patients with allergies to such material or in patients with severe allergies that have required in-hospital treatment. Patients with bleeding disorders should not use products in the Restylane family. Products should not be injected anywhere except the dermis, superficial subcutis (Perlane and Perlane-L only), or lip submucosa (Restylane and Restylane-L only). Restylane-L and Perlane-L should not be used in patients with hypersensitivity to amide-type local anesthetics, such as lidocaine.

Use of products in the Restylane family at the site of skin sores, pimples, rashes, hives, cysts, or infection should be postponed until healing is complete. The most commonly observed side effects are swelling, redness, pain, bruising, and tenderness at the injection site. These are typically mild in severity and resolve in less than 7 days in nasolabial folds and less than 14 days in lips. The incidence of swelling may be higher in patients under 36 years, and the incidence of bruising may be higher in patients over 35 years. Serious but rare side effects include delayed onset infections, recurrence of herpetic eruptions, and superficial necrosis at the injection site. Do not implant into blood vessels. Use with caution in patients recently treated with anticoagulant or platelet inhibitors to avoid bleeding and bruising. Safety has not been established for use during pregnancy, when breastfeeding, or in patients under 18 years for nasolabial folds.

Treatment volume should be limited to 6.0 mL in wrinkles and folds, such as nasolabial folds, and limited to 1.5 mL per lip (Restylane and Restylane‑L only), as higher volume significantly increases moderate and severe injection site reactions. The safety or effectiveness of treatment in areas other than nasolabial folds and lips (Restylane and Restylane-L only) has not been established in controlled clinical studies.

The Restylane family of products is available only through a licensed practitioner.

Except as where otherwise indicated, all product names, slogans, and other marks are trademarks of the Valeant family of companies.
RES 12-128A, B, C