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Teosyal RHA 4 Lidocaine (2 x 1.0 ml)

Teosyal RHA 4 Lidocaine (2 x 1.0 ml)

Teosyal

Dermal filler
  • Teosyal RHA 1–4 fillers, including Teosyal RHA 4, are Class III medical devices and regulated health products bearing the CE marking under EU medical device legislation.
  • Teoxane has obtained EU Medical Device Regulation (MDR) certification for its Teosyal PureSense and Teosyal RHA ranges, confirming compliance with enhanced safety, efficacy and quality requirements.
  • Manufactured under ISO 13485 Compliant quality management systems for medical devices.
  • Non Animal Derived hyaluronic acid dermal filler with very low residual BDDE and documented biocompatibility for injectable facial use.
  • Intended solely for professional use by authorised medical practitioners in accordance with national and regional regulatory frameworks.
Hyaluronic acid dermal filler for deep wrinkles, folds and volumising in thick skin areas

Description

Teosyal RHA 4 Lidocaine (2 x 1.0 ml) is a sterile, transparent, non-pyrogenic, viscoelastic gel of cross-linked, non-animal hyaluronic acid designed to restore volume in the deep layers of the skin and correct pronounced wrinkles and folds in thick, dynamic areas of the face. Part of Teoxane’s Resilient Hyaluronic Acid (RHA) range, RHA 4 is formulated with 23 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine hydrochloride to provide strong volumising and lifting capacity while maintaining natural facial expression. The gel is intended for the filling of deep wrinkles and folds in thick skin areas, such as moderate to severe nasolabial folds and marionette lines, and for augmenting and contouring cheeks, cheekbones, chin and the facial oval. By creating volume within the deep dermis and subcutaneous tissues, Teosyal RHA 4 helps treat skin depressions and sagging, providing structural support, improved elasticity and a more uplifted, youthful appearance. The presence of lidocaine improves patient comfort during injection. As a CE-marked Class III medical device, Teosyal RHA 4 Lidocaine is for professional use only by trained healthcare practitioners.

Bnefits

  • Provides strong volumising and lifting capacity to treat skin depressions, sagging and deep wrinkles in thick skin areas.
  • Formulated specifically for augmenting cheeks, cheekbones, chin and facial contours, restoring a more uplifted and youthful appearance.
  • Indicated for filling deep wrinkles and folds such as moderate to severe nasolabial folds and marionette lines.
  • Resilient Hyaluronic Acid (RHA) technology supports the skin in motion, preserving suppleness, vitality and natural facial dynamics.
  • High hyaluronic acid concentration (23 mg/ml) helps restore hydration, elasticity and firmness to the treated areas.
  • Contains 0.3% lidocaine hydrochloride, a local anaesthetic that reduces pain and improves comfort during and immediately after injection.
  • Biodegradable implant gradually resorbed over time, with an estimated lifetime of approximately 15–18 months depending on patient and treatment factors.
  • Non-animal-derived, highly purified hyaluronic acid with a defined cross-linking level (around 4.0%) for predictable rheology and long-lasting results.
  • Supplied as ready-to-use prefilled syringes with sterile needles and traceability labels for safe, standardised clinical practice.
  • Part of the award-winning Teosyal RHA range manufactured in Switzerland under strict quality and safety standards.

Indications

  • Filling of deep wrinkles and folds in thick skin areas, such as moderate to severe nasolabial folds.
  • Correction of deep facial lines and skin depressions including marionette lines and other lower-face folds.
  • Augmentation and contouring of cheeks and cheekbones to restore midface volume and projection.
  • Chin augmentation and reshaping to improve lower-face profile and facial harmony.
  • Redefinition of the facial oval (jawline and lower face) where structural support and volume are required.
  • General volumisation and support of dynamic facial areas presenting with sagging and tissue ptosis.
  • Improvement of facial contours in patients with age-related volume loss or constitutional lack of volume in thick skin regions.

Composition

  • Cross-linked sodium hyaluronate (hyaluronic acid) 23 mg/ml, non-animal origin, average molecular weight >1 million Daltons.
  • Lidocaine hydrochloride 0.3% by mass (local anaesthetic).
  • Phosphate buffer solution, pH approximately 7.3, q.s. to 1.0 ml per syringe (composition equivalent to the 1.2 ml presentation).
  • BDDE (1,4-butanediol diglycidyl ether) as cross-linking agent; residual BDDE level <1 ppm in the finished product.
  • Degree of modification / cross-linking of hyaluronic acid approximately 4.0% (as reported for Teosyal RHA 4).

Formulation

  • Sterile, apyrogenic, transparent, viscoelastic gel of cross-linked hyaluronic acid with lidocaine for injectable use.
  • Resilient Hyaluronic Acid (RHA) technology using preserved network cross-linking to maintain long HA chains and elasticity adapted to facial movement.
  • Hyaluronic acid concentration: 23 mg/ml.
  • Lidocaine hydrochloride concentration: 0.3% by mass (approximately 3 mg/ml).
  • Biodegradable implant progressively resorbed over time, with an estimated lifetime of 15–18 months.
  • Non-animal-origin HA produced by bacterial fermentation and purified to high standards; cross-linked with BDDE under Teoxane’s preserved-network technology.
  • Designed as a firm, moldable gel with high strength and good stretch to provide soft volume and enhance contours of extended areas such as cheeks, chin, jawline and temples.

Packaging

  • Box containing 2 prefilled glass syringes of Teosyal RHA 4 Lidocaine, each with 1.0 ml of gel.
  • For each 1.0 ml syringe, the box typically contains two sterile 27G 1/2" needles.
  • Two traceability labels per syringe (one to be given to the patient and one to be affixed in the practitioner’s medical records).
  • Sterile blister packaging for syringes and needles.
  • Outer carton printed with product name (Teosyal RHA 4 Lidocaine), content (2 x 1.0 ml), batch/lot number, expiry date, CE marking and manufacturer’s details.

Usage

  • For professional use only: Teosyal RHA 4 Lidocaine must be injected exclusively by legally authorised, appropriately trained healthcare professionals experienced in the use of hyaluronic acid dermal fillers and in facial anatomy.
  • Before treatment, obtain a detailed medical history including allergies (particularly to hyaluronic acid, lidocaine or other amide-type local anaesthetics), autoimmune diseases, bleeding disorders, current medications (e.g., anticoagulants, antiplatelet agents, beta-blockers), previous aesthetic treatments and any history of severe allergic reactions or anaphylaxis.
  • Assess the patient’s face, focusing on deep wrinkles, folds, volume loss and skin quality in thick skin areas (cheeks, nasolabial folds, marionette lines, chin, jawline). Discuss treatment goals, realistic expectations, potential side effects and alternatives; obtain informed consent.
  • Inspect the outer carton, blister and syringes prior to use. Do not use if packaging is damaged, previously opened, or past the expiry date, or if the gel appears cloudy, discoloured, separated or contains visible particles.
  • Maintain strict aseptic technique: thoroughly cleanse and disinfect the treatment area; use sterile gloves, needles and syringes and appropriate barrier precautions.
  • Mount one of the supplied sterile 27G 1/2" needles (or another CE-marked sterile needle or compatible cannula according to clinical judgement) onto the luer-lock tip of the syringe. Do not apply excessive torque or lateral force. Prime the needle by gently depressing the plunger until a small droplet of gel appears at the needle tip.
  • Depending on the indication and anatomical region, inject Teosyal RHA 4 into the deep dermis, the subcutaneous tissue or, where appropriate and in accordance with the Instructions for Use and practitioner training, onto the supraperiosteal plane. Avoid too superficial injections to minimise visibility and irregularities.
  • Use injection techniques suited to deep volumisation such as linear threading, fanning, cross-hatching or small boluses, taking into account local anatomy and desired contour. Inject slowly with minimal pressure and, where clinically appropriate, aspirate according to local practice to reduce the risk of intravascular injection.
  • Do not inject into or directly adjacent to blood vessels or nerves. If the patient experiences severe pain, blanching, colour change or other signs of vascular compromise, stop immediately and follow established emergency management protocols.
  • Avoid overcorrection during the initial session; aim for slight under-correction as some swelling will occur and touch-up sessions can be performed later if necessary.
  • After injection, gently massage the treated areas as needed to ensure even distribution and smooth contour, avoiding excessive pressure that could displace the product or increase bruising.
  • Do not mix Teosyal RHA 4 with other products in the same syringe. Follow Teoxane’s guidance when combining with other aesthetic procedures, spacing treatments appropriately (e.g., chemical peels, lasers, ultrasound) to minimise risk.
  • At the end of the procedure, discard any remaining unused product in the syringe; the syringes and needles are single-use only and must not be re-sterilised or reused. Dispose of all used materials in suitable sharps and clinical waste containers.
  • Advise patients to avoid applying make-up on treated areas for around 12 hours and to avoid exposure to extreme temperatures (intense cold, direct sun, sunbeds, saunas, steam rooms) and vigorous exercise for several days after treatment, as well as to avoid alcohol immediately post-treatment.
  • Recommend that patients do not massage or manipulate treated areas (unless specifically instructed) and, where possible, sleep with the head slightly elevated on the first night to limit swelling.
  • Instruct patients to contact the clinic immediately if they experience severe or increasing pain, blanching or mottling of the skin, marked or expanding redness, significant swelling, changes in vision, or any signs of infection such as warmth, pus, fever or general malaise.

Contraindications

  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics or any of the components of the product.
  • History of severe allergic reactions or anaphylactic shock, particularly in response to injectable products or local anaesthetics.
  • Presence of active skin disease, inflammation, infection or herpes lesions at or near the intended injection sites; injections may trigger reactivation of latent herpes infections.
  • Patients with autoimmune diseases or under immunotherapy, unless the treating physician judges the procedure appropriate after individual risk–benefit assessment in line with the Instructions for Use.
  • Patients with a known tendency to develop hypertrophic scars or keloids in the proposed treatment area.
  • Bleeding disorders or patients on strong anticoagulant or antiplatelet therapy (relative contraindication requiring careful evaluation).
  • Pregnant or breastfeeding women due to lack of adequate clinical data.
  • Patients under 18 years of age.
  • Injection into the most superficial skin layers (epidermis) or into blood vessels is strictly contraindicated.
  • Use in combination with certain aggressive dermatological treatments (e.g., deep chemical peels, ablative laser resurfacing) in the same area at the same time; adequate healing intervals must be respected.

Adverse Effects

  • Common, usually transient injection-site reactions such as redness (erythema), swelling (oedema), tenderness or pain, warmth, itching and bruising/haematoma.
  • Small lumps, nodules or irregularities at the injection sites, generally resolving spontaneously or with light massage; persistent nodules may require medical management.
  • Minor bleeding at the injection site.
  • Temporary changes in sensation (e.g., numbness, tingling, altered sensitivity) around the injected area, related to injection trauma or local anaesthetic effect.
  • Transient firmness or induration in the treated area as the gel integrates with tissues.
  • Delayed inflammatory or hypersensitivity reactions presenting as prolonged redness, swelling, induration or nodules (uncommon).
  • Local infections at injection sites, potentially progressing to cellulitis or abscess formation if aseptic technique or aftercare is inadequate (rare).
  • Granuloma formation or persistent inflammatory nodules (rare), possibly requiring specific pharmacological or surgical treatment.
  • Vascular complications such as inadvertent intravascular injection or compression leading to blanching, severe pain, livedo, tissue ischaemia or necrosis; these require urgent recognition and management.
  • Extremely rare but serious events related to vascular compromise, including visual disturbances or blindness, as well as cerebral ischaemia or stroke, particularly when injecting in high-risk zones; these require immediate emergency intervention.
  • Vasovagal responses (dizziness, sweating, syncope) may occur in susceptible individuals during or after injection.

Storage Conditions

  • Store between 2°C and 25°C (36°F to 77°F); avoid temperature extremes.
  • Do not freeze; discard the product if it has been frozen.
  • Keep syringes in their original blister and outer carton to protect from light and contamination until use.
  • Do not use after the expiry date printed on the outer carton and on each syringe.
  • Do not use if the packaging is damaged, unintentionally opened before use, or if the gel appears cloudy, separated or contains visible particles.
  • The syringes and needles are sterile single-use devices; do not re-sterilise or reuse. Dispose of them in appropriate sharps and clinical waste containers.
  • Store out of the sight and reach of children.

Duration

Teosyal RHA 4 is a biodegradable implant with an estimated lifetime of approximately 15\u201318 months. The duration of effect depends on factors such as skin type, depth of wrinkles, treatment area, injected volume, the patient\u2019s physiology and lifestyle, and whether touch-up or maintenance sessions are performed.

Onset

Volumising and wrinkle-filling effects are visible immediately at the end of the injection session. Final results become more apparent once initial redness and swelling have resolved, typically within a few days to about 2 weeks.

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