Restylane Kysse - Synthetic-fluid tissue reconstructive material, anaesthetic

Intended purpose

Restylane Kysse is intended to restore or augment the volume of the lips. It should be injected into the submucosal layer of the lip. Lidocaine is added to the formulation to diminish the pain resulting from the injection during the treatment.

Functional description

Restylane Kysse is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid at a concentration of 20mg/mL in phosphate buffered saline with the addition of lidocaine hydrochloride 3 mg/mL. Gel is supplied in a prefilled syringe volume of 1 mL. Contents of the syringe are sterilized using moist heat. Syringe is packaged individually in a blister, with two 30G x ½" Ultra thin wall needles. The needles have been sterilized using ethylene oxide. Product is single use only