Hyaluronic acid dermal filler for deep dynamic wrinkles and lip/cheek volume
Certifications
Teosyal RHA 1–4 fillers, including Teosyal RHA 3, are Class III medical devices and regulated health products bearing the CE marking under applicable European medical device regulations.
Teosyal RHA products are CE Marked hyaluronic acid dermal fillers with lidocaine for injection into the dermis, complying with EU safety, health and environmental protection requirements.
Manufactured in accordance with ISO 13485 Compliant quality management systems for medical devices.
Teosyal RHA 1–4 fillers, including Teosyal RHA 3, are Class III medical devices and regulated health products bearing the CE marking under applicable European medical device regulations.
Teosyal RHA products are CE Marked hyaluronic acid dermal fillers with lidocaine for injection into the dermis, complying with EU safety, health and environmental protection requirements.
Manufactured in accordance with ISO 13485 Compliant quality management systems for medical devices.
Non Animal Origin hyaluronic acid formulation meeting high purity and biocompatibility standards for injectable dermal fillers.
Description
Teosyal RHA 3 Lidocaine (2 x 1ml) is a sterile, transparent, non-pyrogenic, viscoelastic gel of cross-linked, non-animal hyaluronic acid designed to treat deep dynamic facial wrinkles and restore volume while preserving natural facial expression. Formulated with 23 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine hydrochloride, it is part of Teoxane’s RHA (Resilient Hyaluronic Acid) range, engineered to support the skin in motion and maintain facial vitality and softness. Teosyal RHA 3 is indicated for the filling of deep facial wrinkles such as moderate to severe nasolabial folds and marionette lines, and can also be used to augment and contour the lips, and to soften deep forehead furrows and other high-mobility areas. The inclusion of lidocaine enhances patient comfort during injection. As a CE-marked Class III medical device, it is intended for use by trained medical professionals for non-surgical facial rejuvenation and contouring.
Bnefits
Designed to treat deep facial wrinkles and folds, including moderate to severe nasolabial folds and marionette lines, while maintaining a natural look in motion.
Supports the skin in every facial movement thanks to resilient cross-linked hyaluronic acid technology, helping preserve facial vitality and softness.
Provides effective volume restoration and contouring, particularly in areas such as the cheeks, lips, and lower face.
Contains 23 mg/ml cross-linked hyaluronic acid for robust volumising and lifting capacity.
Includes 0.3% lidocaine hydrochloride to reduce injection discomfort and improve patient experience.
Non-animal, highly purified hyaluronic acid with a defined crosslinker rate, designed for predictable and long-lasting clinical outcomes.
Suitable for dynamic areas such as nasolabial folds, marionette lines, lips and deep forehead lines, providing natural results both at rest and with expression.
Biodegradable filler that is gradually resorbed by the body, with an estimated duration of effect of 12–18 months depending on indication and patient factors.
Supplied as prefilled syringes with dedicated needles and traceability labels to support safe, standardised clinical practice.
Lidocaine hydrochloride 0.3% (3 mg/ml) for local anaesthetic effect.
Phosphate buffer solution, pH approximately 7.3, q.s. to 1 ml.
Degree of HA modification (crosslinking) approximately 3.6% (BDDE-based crosslinker; BDDE not detected in final product according to some distributor data).
Formulation
Sterile, transparent, non-pyrogenic, viscoelastic gel of cross-linked, non-animal-origin hyaluronic acid.
Resilient Hyaluronic Acid (RHA) technology designed to maintain elasticity and adapt to facial movements for natural dynamic results.
Hyaluronic acid concentration: 23 mg/ml with 0.3% lidocaine hydrochloride.
Crosslinker rate approximately 3.6%, optimised for a balance of durability, flexibility and injection comfort.
Biodegradable filler gradually resorbed over time, with an estimated effect lasting 12–18 months.
Supplied ready-to-use in prefilled glass syringes with luer-lock connection for single use.
Packaging
Box containing 2 x 1 ml prefilled glass syringes of Teosyal RHA 3 Lidocaine.
For each 1 ml prefilled syringe, the box contains two sterile 27G 1/2" needles.
Two traceability labels per syringe (one for the patient and one for the practitioner’s medical record).
Outer carton printed with product name, batch number, expiry date, CE mark and manufacturer details.
Sterile blister packaging for syringes and needles, intended for single use only.
Usage
For professional use only: Teosyal RHA 3 Lidocaine must be injected exclusively by legally authorised and appropriately trained healthcare professionals experienced in the use of hyaluronic acid dermal fillers and facial anatomy.
Before treatment, take a full medical history including allergies (especially to hyaluronic acid, lidocaine, amide-type local anaesthetics, or other components), autoimmune disease, coagulation disorders, concomitant medications (e.g., anticoagulants), and previous aesthetic procedures.
Carefully assess the patient’s facial anatomy, degree of wrinkling, volume loss, and desired outcomes; explain expected results, possible side effects, and alternative treatments, and obtain informed consent.
Check the integrity of the packaging and expiry date. Do not use if blister, syringe, or needles are damaged, opened, or past expiry, or if the gel appears discoloured or contains particulates.
Maintain strict aseptic technique: thoroughly cleanse and disinfect the treatment area; use sterile gloves and appropriate barrier measures.
Attach a supplied 27G 1/2" needle securely to the luer-lock tip of the syringe. Prime the needle and, if necessary, expel air bubbles by gently depressing the plunger until a small droplet appears at the needle tip.
Recommended injection depth is generally the mid to deep dermis for wrinkles and folds; in the lips, injection is typically into the labial mucosa or submucosal plane, according to the Instructions for Use and practitioner training.
Use appropriate injection techniques such as linear threading, serial puncture, fanning, or small bolus injections depending on the treatment area and clinical objective.
Inject slowly with minimal, controlled pressure; aspirate where clinically appropriate and in accordance with local practice to reduce the risk of intravascular injection. Never inject into blood vessels.
Avoid overcorrection in the initial session; aim for slight under-correction, as results can be refined during a follow-up session once initial swelling has resolved.
After injection, gently massage the treated area if necessary to ensure even distribution and smooth contour, taking care not to apply excessive pressure.
Dispose of used syringes, needles, and any remaining product as clinical sharps and pharmaceutical waste; the product is single-use and must not be resterilised or reused.
Post-treatment, advise the patient to avoid applying makeup on the treated areas for approximately 12 hours and to avoid exposure to extreme temperatures (cold, sun, sunbeds, saunas, hammams) as well as intense physical exercise for 24–48 hours.
Recommend that patients avoid massaging or manipulating the treated areas (unless specifically instructed) and sleep with the head slightly elevated on the first night to minimise swelling.
Instruct patients to contact the clinic immediately if they experience intense or increasing pain, blanching or colour changes of the skin, visual disturbance, signs of infection (redness, warmth, pain, fever, discharge), or any other concerning symptoms.
Follow the official Teosyal RHA 3 Instructions for Use for full, product-specific indications, contraindications, warnings and precautions.
Contraindications
Hypersensitivity or allergy to hyaluronic acid, lidocaine, other amide-type local anaesthetics, or any of the components of the product.
History of severe allergic reactions or anaphylaxis, particularly to injectable products or local anaesthetics.
Presence of active skin disease, inflammation, infection, or herpes lesions at or near the intended injection sites.
Tendency to develop hypertrophic scars or keloids in the treatment area.
Autoimmune diseases or immunologic disorders, unless the treating physician judges use to be appropriate after individual risk–benefit evaluation, in line with the IFU.
Bleeding disorders or current use of strong anticoagulant or antiplatelet therapies (relative contraindication; requires careful assessment).
Pregnancy or breastfeeding (use is not recommended due to lack of adequate clinical data).
Patients under 18 years of age.
Injection into blood vessels or into areas with compromised vascularity or prior ischemic events is strictly contraindicated.
Use in combination with certain aesthetic treatments (e.g., deep chemical peels, ablative laser resurfacing) in the same area before complete healing is achieved, as specified in the IFU.
Adverse Effects
Typical transient injection-site reactions such as redness (erythema), swelling (oedema), tenderness or pain, warmth, and bruising.
Small lumps, nodules, or irregularities at the injection sites, usually resolving spontaneously or with gentle massage; rarely may require medical management.
Minor bleeding or hematoma at needle entry points.
Temporary changes in sensation (e.g., numbness, tingling, hyper- or hypoesthesia) related to injection trauma or local anaesthetic effect.
Transient pruritus (itching) or irritation in the treated area.
Delayed hypersensitivity or inflammatory reactions including prolonged redness, swelling, induration or nodules (uncommon; may require specific treatment).
Infection at the injection site, potentially leading to cellulitis or abscess formation if aseptic technique is not followed or aftercare is inadequate (rare).
Granuloma formation or persistent nodules (rare), necessitating specialist evaluation and possible pharmacologic or procedural management.
Vascular complications including inadvertent intravascular injection or compression of vessels, which can cause blanching, severe pain, livedo, tissue ischemia or necrosis, and in very rare cases visual disturbance or blindness; these events require immediate emergency management.
As with any procedure involving needles and local anaesthetic, there is a small risk of vasovagal reactions, dizziness, or syncope in susceptible individuals.
Storage Conditions
Store between 2°C and 25°C (36°F–77°F).
Do not freeze; discard the product if it has been frozen.
Keep in the original packaging to protect from light and contamination until the time of use.
Do not use after the expiry date indicated on the packaging and syringe labels.
Store out of the sight and reach of children.
Duration
According to the Instructions for Use, the estimated duration of effect of Teosyal RHA 3 is approximately 12 to 18 months, depending on factors such as treatment area, injection technique, and patient-specific characteristics.
Onset
Volumising and wrinkle-filling effects are immediate and visible at the end of the injection session, with final results becoming more apparent after initial swelling and redness resolve, typically within a few days to around 2 weeks.
