Sterile gel, apyrogenic, viscoelastic, colorless and transparent. It is composed of cross-linked sodium hyaluronate of non-animal origin and provided in a saline phosphate buffer. Belotero Lips Shape contains 0.3% lidocaine hydrochloride.
It is an injectable and biodegradable gel indicated for correcting atrophic scars of the face and for reshaping the volume of soft tissues, such as the volume of the lips and deep oral commissures. It is also suitable for correcting atrophic scars of the face. The presence of lidocaine allows for the reduction of local pain associated with the injection of the gel, improving patient comfort.
* The application of the product is reserved exclusively for qualified healthcare professionals.
*MEDICAL DEVICE
Ingredients:
– Cross-linked sodium hyaluronate (22.5 mg/ml)
– Lidocaine hydrochloride (3.0 mg/ml)
Instructions for Use:
It is recommended to use the needles provided in the package. The use of 27 G x ½ needles included in the package is recommended, as a smaller diameter would require greater force during the injection of the gel. Belotero Lips Shape should be injected slowly. The amount of gel to be injected depends on the area to be treated and the desired correction. Over-correction is not necessary. After injection, perform a light massage on the treated area to evenly distribute the product.
Warnings:
– Do not inject into blood vessels or in areas with inflammatory or infectious skin problems (such as acne or herpes) or in an area previously treated with permanent dermal filler.
– It is recommended to perform a preliminary test in patients with progressive diseases and to monitor them closely after injection.
– Do not inject in patients with a history of streptococcal infections or those prone to hypertrophic or keloid scars.
– Do not use in conjunction with other aesthetic medical techniques such as peels, dermabrasion, or laser treatments before complete healing of the last treatment.
– Check the integrity of the package and the expiration date before use.
– Patients taking antithrombotics such as aspirin or non-steroidal anti-inflammatory drugs may be at a higher risk of developing hematomas, nodules, or bleeding at the injection site.
– Consult a physician before use in patients with epilepsy, cardiac impairment, severe hepatic or renal impairment, or porphyria.
– Lidocaine may cause positive results in anti-doping tests.
– Do not transfer the product to another container or add other ingredients.
– After use, dispose of the syringe and any residual product. Do not re-sterilize or reuse.
– Avoid makeup for at least 12 hours after treatment and avoid prolonged sun exposure or UV rays for 2 weeks.
– Avoid applying pressure or manipulating the treated area.
Storage:
Store between 2°C and 25°C, protect from light and frost, avoid mechanical shocks.
Format:
The package contains:
– A leaflet
– A pre-filled syringe
– 2 traceability labels
– 2 sterile single-use needles
