RHA Kiss Volume Lido is a sterile, transparent, non-pyrogenic, viscoelastic gel made of hyaluronic acid (HA) of non-animal origin and of mean molecular weight higher than 1 million Dalton. It is crosslinked with BDDE (1,4-Butanediol diglycidyl ether), and contains 0.3% by mass of lidocaine hydrochloride, for its anaesthetic properties. Each box contains two pre-filled 1ml syringes of RHA® Kiss Volume Lido. For each syringe, the box contains two sterile 30G1/2” needles and two traceability labels (one to be given to the patient, and one to be kept by the doctor in the patient medical records). The volume of gel in each syringe is indicated on the cardboard box as well on each syringe.

Direction:

Aesthetic indications of RHA Kiss Volume Lido:

RHA Kiss Volume Lido is indicated for the correction of any deep facial wrinkles, deep skin creases and to add volume in the midface region (nasolabial folds) and in the perioral region (lips including philtrum, marionette lines, oral commissures). Lidocaine hydrochloride is a local anesthetic agent designed to reduce the sensation of pain.

Caution: RHA Kiss Volume Lido must not be used in the case of:

• patients having cutaneous disorders, inflammation or infection at or near to the treatment site. Injection procedures can lead to reactivation of latent or subclinical herpes viral infection,
• patients having a known hypersensitivity to hyaluronic acid, with a history of severe allergy or anaphylactic shock,
• patients with autoimmune diseases,
• pregnant, breastfeeding women, or patients less than 18 years old.

Because of the presence of lidocaine, RHA Kiss Volume Lido must not be used in the case of:

• known hypersensitivity to lidocaine and/or amide local anesthetic agents,
• patients with cardiac diseases and/or undergoing treatment for heart diseases (beta blockers),
• patients with hepatocellular insufficiency and/or undergoing treatment for a liver disease,
• patients suffering from epilepsy or porphyria.

Do not use in combination with other aesthetic procedures (such as peeling, laser treatment or ultrasound-based treatment). Do not inject in the most superficial layer of the skin (epidermis), and in injection depths other than those described in “Dosage and method of administration” section of the IFU. Do not inject into or close to a blood vessel or close to a nerve.

Ingredients:

• Hyaluronic acid 23 mg/mL
• Degree of crosslinking*< 5% (*Measured by Nuclear Magnetic Resonance (NMR) analysis.)

Other ingredients:

• Lidocaine hydrochloride: 0.3% by mass
• Phosphate buffer pH 7.3: .q.s. ad 1mL
• BDDE as crosslinking agent: < 1 ppm