Belotero® Lips Contour with Lidocaine 0.6 ml

Belotero

Dermal filler

Hyaluronic acid lip filler for contour and fine perioral lines

CE Marked Class III medical device for soft tissue augmentation in the lips and perioral area.
Manufactured under ISO 13485 Compliant quality management system and Good Manufacturing Practice standards for sterile medical devices.
Conforms to applicable EU/UK medical device regulations for injectable, resorbable hyaluronic acid fillers.
Non Animal origin hyaluronic acid produced via controlled bacterial fermentation with validated purification processes.

CE Marked Class III medical device for soft tissue augmentation in the lips and perioral area.
Manufactured under ISO 13485 Compliant quality management system and Good Manufacturing Practice standards for sterile medical devices.
Conforms to applicable EU/UK medical device regulations for injectable, resorbable hyaluronic acid fillers.
Non Animal origin hyaluronic acid produced via controlled bacterial fermentation with validated purification processes.

Hyaluronic acid lip filler for contour and fine perioral lines

Description

Belotero® Lips Contour with Lidocaine 0.6 ml is a sterile, injectable, cross-linked hyaluronic acid dermal filler specifically formulated for precise lip contouring and rejuvenation of the perioral area. Using Belotero’s CPM (Cohesive Polydensified Matrix) technology, the gel integrates smoothly into the delicate lip tissue to refine the vermilion border, define the Cupid’s bow, correct slightly drooping mouth corners and smooth smoker’s lines (perioral wrinkles) while maintaining natural lip movement. The filler contains cross-linked sodium hyaluronate at 22.5 mg/ml combined with 3 mg/ml lidocaine hydrochloride in a phosphate buffer (0.6 ml total), providing immediate visible enhancement with improved patient comfort during injection. Results typically last around 6–9 months, depending on individual factors.

Bnefits

Designed specifically for the delicate lip and perioral area, providing precise contouring and definition of the lip border and Cupid’s bow.
Refines lip contour, enhances subtle lip volume and shape, and creates a well-defined, balanced lip heart.
Smooths fine perioral wrinkles (smoker’s lines) and addresses slightly drooping mouth corners for a more youthful and harmonious appearance.
CPM (Cohesive Polydensified Matrix) technology ensures excellent tissue integration, reducing the risk of lumps and irregularities and delivering smooth, natural-looking results.
Cross-linked hyaluronic acid (22.5 mg/ml) provides strong yet subtle lifting and contouring with a soft, flexible feel in motion.
Contains 3 mg/ml lidocaine to reduce injection discomfort and improve overall treatment tolerability.
Results are typically long-lasting, with clinical effect usually maintained for approximately 6–9 months, depending on metabolism, lifestyle and treatment area.
Resorbable, non-animal origin hyaluronic acid with high biocompatibility and a well-established safety profile.
Can be combined with other Belotero fillers (e.g., Lips Shape, Balance, Intense) to fully individualise lip and lower-face rejuvenation.

Indications

Non-surgical enhancement and definition of the lip contour and vermilion border.
Shaping and accentuation of the Cupid’s bow and lip heart.
Subtle enhancement of overall lip volume and correction of mild asymmetries.
Softening and smoothing of superficial perioral wrinkles (smoker’s lines) above the upper lip.
Correction of slightly drooping mouth corners (labial commissures) to restore a more neutral or uplifted appearance.
Improvement of the overall aesthetic appearance of the lips and surrounding perioral area in adults.

Composition

Cross-linked sodium hyaluronate (hyaluronic acid) 22.5 mg/ml (non-animal origin, produced by fermentation of Streptococcus equi).
Lidocaine hydrochloride 3.0 mg/ml (local anaesthetic to reduce pain at the injection site).
Phosphate buffer pH 7 q.s. to 0.6 ml (physiological buffer solution).

Formulation

Sterile, non-pyrogenic, viscoelastic, colourless and transparent gel of cross-linked sodium hyaluronate with lidocaine.
Hyaluronic acid concentration: 22.5 mg/ml.
Lidocaine hydrochloride concentration: 3.0 mg/ml (approximately 0.3% w/v).
Volume per syringe: 0.6 ml prefilled single-use glass syringe.
CPM (Cohesive Polydensified Matrix) cross-linking technology for high cohesivity, elasticity and smooth integration in delicate lip tissue.
Intended for injection into the superficial to mid dermis and submucosa of the lips and perioral region.

Packaging

One single-use prefilled glass syringe containing 0.6 ml Belotero® Lips Contour with Lidocaine, sterilised by moist heat.
Each box typically contains: 1 x 0.6 ml syringe, 2 x sterile CE-marked needles (commonly 27G and/or 30G, needle size specified on the outer box), 2 traceability labels and 1 instructions-for-use leaflet.
Outer carton printed with product name, volume, composition, batch number, expiry date, CE mark, manufacturer details and storage conditions.

Usage

Belotero® Lips Contour with Lidocaine is for exclusive use by suitably trained and licensed healthcare professionals experienced in dermal filler injections and facial anatomy.
Obtain a complete medical history including allergies (especially to hyaluronic acid, lidocaine or other amide-type local anaesthetics), history of severe allergies or anaphylaxis, bleeding disorders, autoimmune disease, prior fillers and current medications.
Examine and mark the treatment areas (lip border, Cupid’s bow, perioral wrinkles, mouth corners) and discuss realistic expectations with the patient.
Cleanse and disinfect the treatment area thoroughly using an appropriate antiseptic solution.
Remove the syringe from its blister, attach one of the supplied sterile needles securely and expel any air according to the instructions for use, ensuring that a small droplet of gel appears at the needle tip.
Inject slowly using appropriate techniques such as linear threading, serial puncture or fanning into the superficial to mid dermis or submucosa of the lips, depending on the indication and local anatomy.
Use minimal pressure and aspirate in accordance with clinic protocol to reduce the risk of intravascular injection; avoid injection into or near major blood vessels.
Do not overcorrect; gradually build the desired contour and definition, reassessing frequently to maintain a natural appearance.
After injection, gently massage the area if required to ensure even distribution and smooth contour, unless local anatomy or technique dictates otherwise.
Dispose of any unused product, needles and syringes as clinical sharps in accordance with local regulations; each syringe is strictly single-use for one patient only.
Provide post-procedure advice: patients should avoid makeup on the treated area for several hours, avoid excessive heat or cold exposure, saunas, sunbeds and vigorous exercise for 24 hours, and should not massage or press the area unless advised. Instruct them to seek immediate medical attention if they experience severe pain, blanching, visual changes or unusual symptoms.
Record the product batch number, injection volumes and sites in the patient’s record and apply traceability labels where required.

Contraindications

Known hypersensitivity or allergy to hyaluronic acid, lidocaine, other amide-type local anaesthetics or any of the excipients in the product.
History of severe allergies or anaphylactic reactions, or presence of multiple severe allergies.
Known allergy to gram-positive bacterial proteins (as the hyaluronic acid is produced by bacterial fermentation).
Presence of active skin disease, infection, inflammation or lesions (e.g. herpes labialis, dermatitis, acne, fungal infection) at or near the intended injection site.
Tendency to develop hypertrophic scars or keloids.
Bleeding disorders or current use of anticoagulant/antiplatelet medication without careful risk–benefit assessment and appropriate precautions.
Intravascular injection is strictly contraindicated due to risk of vascular occlusion, ischaemia, necrosis or embolic events.
Use in pregnant or breastfeeding women is not recommended due to a lack of adequate clinical data.
Not recommended in patients under 18 years of age.
Avoid injection in areas previously treated with permanent or semi-permanent fillers unless the practitioner judges it safe and appropriate, taking into account the risk of interactions or irregularities.

Adverse Effects

Common, usually transient injection-site reactions such as redness (erythema), swelling, tenderness, pain, itching, bruising, induration or local warmth.
Temporary oedema and sensitivity of the lips and perioral region, typically resolving within a few days.
Haematoma or bruising due to needle insertion, particularly in highly vascular areas.
Palpable nodules, lumpiness or irregularities which may require massage, clinical observation or further management if persistent.
Hypersensitivity or allergic reactions, potentially including localised swelling, erythema or more generalised responses; severe reactions require prompt medical attention.
Localized infection at the injection site (e.g. cellulitis or abscess) if aseptic technique or post-treatment care are inadequate.
Very rare but serious vascular complications such as arterial occlusion, tissue necrosis, and visual disturbances or blindness if filler is inadvertently injected intravascularly; these events require urgent specialist management.
Delayed inflammatory reactions, granuloma formation or prolonged swelling may occur rarely with hyaluronic acid fillers.

Storage Conditions

Store between 2°C and 25°C in a dry place.
Do not freeze.
Keep the syringe in its original blister and outer carton to protect from light until immediately before use.
Do not use after the expiry date printed on the packaging.
Do not use if the blister, outer carton or syringe is damaged, or if the gel appears cloudy, discoloured or contains visible particles.
Keep out of the sight and reach of children and unauthorised persons.

Duration

Clinical effect is typically maintained for approximately 6 to 9 months, depending on factors such as the injection site, volume used, patient age, skin quality, metabolism, smoking status and lifestyle. Maintenance or touch-up treatments are usually required to sustain optimal results.

Onset

Visible enhancement and contouring are generally immediate due to the volume of the hyaluronic acid gel, with the final aesthetic result stabilising over several days as any initial swelling, redness or minor bruising subsides.