BELOTERO LIPS CONTOUR

BELOTERO Lips Contour is a sterile gel:
- Apyrogenic and physiological cross-linked hyaluronic acid of non-animal origin.
- Biodegradable, transparent, colourless and homogenised viscoelastic implant.
- Composed of cross-linked hyaluronic acid (sodium hyaluronate) at a concentration of 22.5 mg/ml and lidocaine hydrochloride 3.0 mg/ml in phosphate buffer pH 7.
- Restoration and definition of the lip contour. Indicated for improving the lip contour and correcting perioral lines.
- CPM (Cohesive Polydensified Matrix) TECHNOLOGY
- Cohesive, flexible, unique formulation for controlled and precise injection with homogeneous distribution in the dermis.

- MERZ PHARMA ITALIA S.R.L.
- NAME: BELOTERO LIPS CONTOUR
- COMPOSITION: Cross-linked sodium hyaluronate: 22.5 mg/ml
Lidocaine hydrochloride: 3.0 mg/ml
Phosphate buffer pH 7 q.a.: 0.6 ml
- PRESENTATION: 1 x 0.6ml.
- NEEDLES: 2 x 27 G1/2.
- INDICATIONS: BELOTERO Lips Contour is indicated for injection into the superficial to medium dermis for the treatment of lip contour, perioral lines and moderate oral commissures. BELOTERO Lips Contour is indicated for lip remodelling.
- INJECTION DEPTH: subcutaneous or submucosa / in the lacrimal groove area, inject deep into the bone below the orbicularis orbicularis muscle of the eye.
- DURATION: The duration of the effect may vary depending on several factors, including individual skin characteristics, lifestyle and skin care routine. For best results and to maintain the effect over time, it is advisable to follow the manufacturer's instructions and consult a qualified professional.
- USE: Strict medical use.

- Syringe: 1 x 0.6 ml.
- Needles : 2 x 27 G1/2 (CE 0120).
- The gel is sold in a pre-filled, disposable graduated syringe.
- Each box contains one 0.6mL syringe of BELOTERO Lips Contour, 2 sterile disposable 27G1/2” needles reserved exclusively for injecting BELOTERO Lips Contour, instructions for use and two labels to ensure traceability.

Redefines the lip contour. Reshapes the lips.

- Cross-linked sodium hyaluronate: 22.5 mg/ml
- Lidocaine hydrochloride: 3.0 mg/ml
- Phosphate buffer pH 7 q.a.: 0.6 ml.

BELOTERO Lips Contour is only indicated for subcutaneous and submucosal injections. Inject BELOTERO Lips Contour slowly to apply as little pressure as possible, depending on the appropriate injection technique, using the needles provided. Inject BELOTERO Lips Contour slowly to apply as little pressure as possible, depending on the appropriate injection technique, using the needles provided. The risk of intravascular injection can be reduced by using several strategies, including suctioning prior to injection, using smaller volumes and serial injections in high-risk areas, treating one side at a time, pinching/tensing the skin to provide more surface area to the branches of the main arteries, and manually occluding the origin of the supratrochlear vessels with the non-dominant finger. A blunt-tipped cannula can reduce, but not eliminate, the risk. General recommended injection techniques are, for example: linear or serial injection, fan technique, lattice technique or serial (micro)puncture technique. The amount of product to be injected depends on the area to be corrected. In general, the injection of medical devices carries a risk of infection. Standard precautions associated with injectable materials must be observed. Limited clinical data are available on the injection of BELOTERO Lips Contour in patients with Fitzpatrick skin type V/VI.

BELOTERO Lips Contour is contraindicated in the following cases:
- In case of known hypersensitivity to one or more components of the product, in particular to sodium hyaluronate, lidocaine hydrochloride,
to BDDE or amide local anaesthetics;
- In pregnant or breastfeeding women;
- In young patients under 18 years of age;
- In patients with a general infection;
- In patients with an active autoimmune disease.
Do not inject BELOTERO Lips Contour into the blood vessels.
Do not inject BELOTERO Lips Contour into areas of the skin where there is active skin inflammation or infection due to, for example
for example, to immunological, allergic, bacterial, fungal or viral causes.
Do not inject BELOTERO Lips Contour into an area previously treated with permanent dermal filler.
Do not inject BELOTERO Lips Contour into the glabellar and nasal region.

INDICATIONS
BELOTERO Lips Contour is a resorbable injectable implant indicated for improving the lip contour, correcting fine perioral lines and defining clefts.

The contents of the BELOTERO Lips Contour syringe are sterilised by moist heat. The 27G1/2” needles are sterilised by irradiation.