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Belotero Soft

Belotero Soft

Belotero

Injectable dermal filler
  • CE Marked hyaluronic acid dermal filler/implant for intradermal injection in applicable European and associated markets.
  • Class III medical device (injectable implant) manufactured under ISO Compliant quality management systems and Good Manufacturing Practice (GMP) for medical devices.
  • Non Animal, bacterially fermented HA meeting relevant purity and safety standards for injectable medical devices.
  • Part of the Belotero range, which has clinical data supporting safety and efficacy in the treatment of facial lines and skin quality improvement when used as directed.
  • Complies with applicable EU/UK medical device regulations and local regulatory requirements in markets where authorised.
Hyaluronic acid superficial line filler with lidocaine

Description

Belotero Soft with Lidocaine (1 x 1.0ml) is a cross-linked hyaluronic acid (HA) dermal filler from the Belotero portfolio by Merz Aesthetics, specifically designed to treat superficial lines and fine wrinkles. Formulated with 20 mg/ml cross-linked sodium hyaluronate and 0.3% lidocaine hydrochloride in a phosphate buffer, it provides gentle yet effective smoothing of crow’s feet, perioral lines, forehead lines and other fine, superficial wrinkles. Its cohesive polydensified matrix (CPM) technology allows the gel to integrate smoothly into the superficial dermis, creating very natural-looking results and soft transitions between treated and untreated areas. In addition to wrinkle correction, Belotero Soft supports deep skin rehydration thanks to the water-binding capacity of HA, improving skin elasticity and texture while maintaining normal facial expression. Supplied as a sterile, prefilled 1 ml syringe with fine 30G needles, it is intended strictly for use by trained healthcare professionals.

Bnefits

  • Targets superficial lines and fine wrinkles such as crow’s feet, perioral lines, forehead lines and other mild facial rhytides.
  • Cross-linked hyaluronic acid (20 mg/ml) provides subtle, precise correction without excessive volumisation, ideal for delicate areas.
  • Contains 0.3% lidocaine for increased patient comfort during injection.
  • Cohesive, polydensified matrix gel integrates smoothly into the superficial dermis for very natural look and feel.
  • Excellent water-binding capacity promotes deep skin rehydration, improved elasticity and smoother texture.
  • Helps refine skin surface, soften etched-in lines and improve overall radiance and skin quality.
  • Predictable, reproducible outcomes when used according to recommended indications and technique.
  • Typically long-lasting results of approximately 6–12 months, with many patients maintaining improvement for up to 12 months.
  • Single-use, sterile prefilled syringe with fine 30G needles facilitates precise, minimally invasive treatment.

Indications

  • Correction of superficial lines and fine wrinkles in the face.
  • Treatment of crow’s feet in the peri-orbital area (in suitably trained hands and in accordance with local labelling).
  • Correction of fine perioral lines, including smoker’s lines and upper lip wrinkles.
  • Treatment of fine forehead lines and other mild superficial rhytides.
  • Fine line correction and textural improvement around the mouth and chin area.
  • Treatment of superficial atrophic skin scars and fine lines in selected indications, as per professional judgement and local regulations.
  • Improvement of skin hydration and fine lines on delicate areas such as the décolletage or other superficial facial regions, where supported by local guidelines.

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) 20 mg/ml (non-animal origin).
  • Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic for patient comfort.
  • Phosphate buffer, pH approximately 7, q.s. to 1.0 ml of gel.
  • 1,4-butanediol diglycidyl ether (BDDE) as the cross-linking agent (residual levels within accepted safety limits).
  • Sterile, apyrogenic, viscoelastic, transparent, colourless gel; latex-free and bioresorbable.

Formulation

  • Sterile, non-pyrogenic, viscoelastic cross-linked hyaluronic acid gel containing 0.3% lidocaine in a phosphate buffer.
  • Cohesive polydensified matrix structure designed to integrate evenly into the superficial dermis for smooth transitions.
  • Transparent, colourless gel suitable for superficial dermal injection, providing subtle and homogeneous correction.
  • Non-animal, bacterially fermented HA with controlled cross-linking for stability and durability.
  • Single-use, prefilled 1 ml glass syringe with Luer lock connection, supplied ready for use by a healthcare professional.

Packaging

  • 1 x 1.0 ml prefilled glass syringe of Belotero Soft with Lidocaine (cross-linked sodium hyaluronate 20 mg/ml + lidocaine hydrochloride 0.3%).
  • 2 x 30G 1/2" sterile disposable needles (or equivalent fine gauge needles as specified on the pack/IFU).
  • Sterile blister pack maintaining syringe and needles under aseptic conditions until opening.
  • Outer cardboard carton printed with product name, batch/lot number, expiry date, storage conditions, manufacturer details and CE marking.
  • Instructions for Use (IFU) leaflet providing detailed indications, contraindications, warnings, precautions and injection technique guidance.

Usage

  • For professional use only: Belotero Soft with Lidocaine must be injected exclusively by appropriately trained and qualified healthcare professionals familiar with facial anatomy and dermal filler techniques.
  • Indicated for injection into the superficial to mid-dermis for the correction of superficial lines and fine wrinkles; injection depth and technique should follow the official Instructions for Use and current best practice.
  • Use aseptic technique: thoroughly cleanse and disinfect the treatment area and maintain sterile handling of the syringe and needles.
  • Attach the supplied 30G needle firmly to the syringe; expel air bubbles carefully before injection.
  • Inject slowly with minimal pressure, using techniques such as serial puncture, linear threading, or micro-aliquot placement in the superficial dermis, avoiding overcorrection.
  • Distribute the product evenly along the wrinkle or treatment area to achieve smooth, natural-looking correction; gently massage if recommended in the IFU to ensure even integration.
  • Do not inject into blood vessels; always consider vascular anatomy and use aspiration and low injection pressure where appropriate to reduce the risk of intravascular injection.
  • Do not use in areas with active skin disease, inflammation or infection (e.g., acne, herpes, dermatitis) at or near the planned injection sites.
  • Typical duration of effect is around 6–12 months; retreatment may be performed according to clinical need, patient expectations and local recommendations.
  • Single-use device: never reuse any remaining product or needle; discard all used materials in accordance with local sharps and clinical waste regulations.
  • Patients should be advised to avoid applying makeup to treated areas for several hours, and to avoid extreme temperatures, saunas, sunbeds, excessive sun exposure and vigorous exercise for the first 24 hours post-treatment or as directed by the practitioner.

Contraindications

  • Known hypersensitivity or allergy to hyaluronic acid, lidocaine, amide-type local anaesthetics, or any of the excipients (including phosphate buffer components or BDDE).
  • History of severe anaphylactic reactions or multiple severe allergies.
  • Presence of active skin infections, inflammation or lesions (e.g., cold sores, acne, dermatitis, rash) at or near the intended injection site.
  • Patients with untreated epilepsy, significant cardiac conduction disorders, or other conditions in which lidocaine-containing products are contraindicated, unless carefully assessed and deemed appropriate by a specialist.
  • Known bleeding disorders, significant coagulation abnormalities, or current use of anticoagulant or antiplatelet therapy without individual risk assessment.
  • Patients with autoimmune diseases or under significant immunosuppressive therapy, unless risks and benefits have been carefully evaluated in accordance with local guidance.
  • History of hypertrophic scarring or keloid formation in areas to be treated.
  • Previous permanent or non-bioresorbable filler in the planned injection area unless a careful risk assessment is performed.
  • Pregnant or breastfeeding women (use is generally not recommended due to lack of adequate safety data).
  • Patients under 18 years of age.
  • Any additional contraindications specified in the official Belotero Soft with Lidocaine Instructions for Use and local regulatory labelling, including strict prohibition of intravascular injection.

Adverse Effects

  • Very common, usually transient injection-site reactions such as redness (erythema), swelling, oedema, tenderness, pain, itching, warmth, bruising or minor bleeding.
  • Small papules or bumps at injection points due to superficial dermal placement, typically resolving within a few days.
  • Induration, firmness or palpable product in the treated region, which usually improves with time and/or gentle massage.
  • Local discolouration, ecchymosis or haematoma at or near the injection sites.
  • Asymmetry, irregular contour or over/undercorrection, which may require adjustment in subsequent sessions.
  • Local inflammatory or hypersensitivity reactions (redness, swelling, pruritus, rarely more extensive allergic responses).
  • Infection at the injection site, including rare cases of abscess formation or delayed biofilm-associated reactions.
  • Granuloma formation or delayed inflammatory nodules, which may require specific medical management (e.g., pharmacologic treatment or other interventions).
  • Very rare but serious complications related to inadvertent intravascular injection, including vascular occlusion, tissue ischaemia or necrosis, and, in high-risk facial areas, potential visual disturbances or blindness; these constitute medical emergencies requiring immediate specialist management.
  • Other adverse events listed in the official Belotero Soft with Lidocaine Instructions for Use and post-marketing safety information.

Storage Conditions

  • Store in accordance with the manufacturer’s labelling, typically at controlled room temperature within the specified range (commonly about 2–25 °C).
  • Do not freeze; avoid exposure to extreme heat, cold or direct sunlight.
  • Keep the syringe in its original blister and outer carton until use to maintain sterility and protect from light.
  • Do not use the product after the expiry date printed on the syringe label and outer packaging.
  • Do not use if the blister or packaging is damaged, if the syringe has been dropped, or if the solution appears cloudy, coloured or shows particulate matter.
  • Single-use only: once the sterile blister is opened and the syringe used for a single patient, any remaining gel must be discarded.
  • Store out of sight and reach of children and non-professional users.

Duration

Clinical experience and product information indicate that correction with Belotero Soft with Lidocaine typically lasts around 6\u201312 months, with many patients maintaining satisfactory improvement in fine lines and skin quality for up to 12 months depending on skin type, treatment area, injected volume, technique and lifestyle factors.

Onset

Results are usually visible immediately after injection, with instant softening of superficial lines and fine wrinkles; additional improvement in hydration and skin texture may evolve over the following days to weeks as the gel integrates and binds water within the dermis.

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