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Restylane Skinboosters Vital with Lidocaine (1 x 1.0 ml)

Restylane Skinboosters Vital with Lidocaine (1 x 1.0 ml)

Restylane

Injectable Medical Device
  • CE Marked hyaluronic acid skin booster for improvement of skin quality and hydration in applicable European and international markets.
  • Manufactured using non Animal stabilized hyaluronic acid (NASHA technology) and BDDE crosslinking in compliance with quality and safety standards for sterile injectable medical devices (typically Class III).
  • Subject to regulatory post Market surveillance and adverse event (device vigilance) reporting in territories where it is marketed.
  • Supported by clinical studies demonstrating improvements in skin hydration, elasticity, smoothness and reduction of fine lines in treated areas.
Hyaluronic Acid Skin Booster

Description

Restylane Skinboosters Vital with Lidocaine is an injectable hyaluronic acid skin booster designed to provide deep hydration and improve overall skin quality. The product is a sterile, transparent gel of non-animal stabilized hyaluronic acid (NASHA) at 20 mg/mL, combined with 0.3% lidocaine and a physiological sodium chloride solution at pH 7. Injected into the superficial to mid dermis, it boosts hydration levels deep within the skin, improving smoothness, elasticity and firmness while restoring a natural glow. It is intended for treatment of face, neck, décolleté, back of the hands and arms, particularly in mature or sun-damaged skin, helping to reduce fine lines and enhance skin texture and tone.

Bnefits

  • Boosts hydration levels deep within the skin for lasting moisture.
  • Improves skin smoothness, elasticity and firmness.
  • Enhances overall skin texture and tone for a more radiant, natural glow.
  • Reduces the appearance of fine lines, especially in photo-damaged or mature skin.
  • Specifically designed as a skin quality booster rather than a volumising filler.
  • Suitable for multiple treatment areas including face, neck, décolleté, hands and arms.
  • Contains 0.3% lidocaine to reduce injection discomfort and improve patient comfort.
  • Uses non-animal stabilized hyaluronic acid (NASHA) with an established safety profile.
  • Can be used in treatment protocols to progressively improve skin quality over several sessions.

Indications

  • Improvement of overall skin quality by increasing hydration, elasticity and firmness.
  • Treatment of fine lines and superficial wrinkles, especially in photo-damaged or mature skin.
  • Skin quality enhancement and deep hydration of the face.
  • Skin quality enhancement and deep hydration of the neck and décolleté.
  • Skin quality enhancement and deep hydration of the back of the hands.
  • Skin quality enhancement of the arms and other suitable areas with signs of dryness or loss of elasticity.
  • General skin rejuvenation where a skin booster (rather than a volumising filler) is clinically appropriate.

Composition

  • Stabilized sodium hyaluronate (hyaluronic acid) 20 mg/mL, non-animal origin (NASHA technology).
  • Lidocaine hydrochloride 3 mg/mL (0.3% lidocaine) as a local anaesthetic.
  • Physiological sodium chloride solution (normal saline), pH approximately 7.
  • Phosphate buffered saline solution, q.s. to 1.0 mL.
  • Sterile, clear, viscoelastic, biodegradable gel free from animal proteins.

Formulation

  • Sterile, transparent, cross-linked hyaluronic acid gel at a concentration of 20 mg/mL with 0.3% lidocaine hydrochloride in a physiological sodium chloride solution at pH ~7, produced using NASHA (non-animal stabilized hyaluronic acid) technology. The product is presented as a ready-to-use injectable skin booster intended for intradermal implantation in the superficial to mid dermis to improve skin hydration, elasticity and texture.

Packaging

  • 1 x 1.0 ml pre-filled glass syringe of Restylane Skinboosters Vital with Lidocaine (per unit supplied by the distributor).
  • Syringe supplied sterile in an individual blister pack for single-patient use.
  • Supplied with sterile disposable injection needles (typically fine-gauge, e.g. 30G or similar; exact configuration can vary by market and pack).
  • Luer-lock syringe with tamper-evident cap to maintain sterility prior to use.
  • Outer carton labelled with product name, volume, batch/lot number, expiry date, manufacturer details and regulatory markings.
  • Traceability / patient record labels for placement in the patient’s medical records.

Usage

  • For professional use only: Restylane Skinboosters Vital with Lidocaine must be administered exclusively by appropriately trained and legally authorised healthcare professionals experienced in dermal injections and anatomy of the treatment areas.
  • Before use, inspect the outer carton, blister and syringe; do not use if any packaging is damaged, sterility may be compromised, the gel appears cloudy or contains particles, or if the product is past its expiry date.
  • Obtain a full medical history including allergies (particularly to hyaluronic acid, lidocaine or other amide-type local anaesthetics and gram-positive bacterial proteins), bleeding disorders, autoimmune conditions, previous aesthetic treatments and current medications (especially anticoagulants and antiplatelet agents).
  • Cleanse and disinfect the treatment area (face, neck, décolleté, hands, arms) according to standard clinic protocols for injectable treatments.
  • Attach a suitable sterile needle (often a fine-gauge 29–30G needle or compatible cannula) securely to the luer-lock syringe using aseptic technique and expel any air before beginning injections.
  • Inject the product into the superficial to mid dermis using micro-depot, serial puncture, linear threading or nappage techniques, placing small aliquots evenly across the treatment area to create a uniform, subtle hydrating effect.
  • Inject slowly with minimal pressure and aspirate where appropriate to reduce the risk of intravascular injection, even though injection is intended for the superficial dermis.
  • Avoid overcorrection; spread the total dose across the treatment area according to the patient’s needs and the Instructions for Use.
  • Gently massage the treated area if necessary to ensure even distribution of the gel, avoiding excessive pressure.
  • Do not inject into areas with active skin disease, inflammation or infection. Stop the procedure immediately if the patient develops intense pain, blanching or any signs suggestive of vascular compromise, and manage according to current clinical guidelines.
  • Typical treatment protocols involve a series of initial sessions (for example, 2–3 treatments spaced about 3–4 weeks apart), followed by maintenance treatments approximately every 3–6 months, adjusted to individual response and local guidelines.
  • After treatment, advise the patient to avoid makeup on the treated area for several hours and to avoid extremes of temperature, sunbeds, saunas, vigorous exercise and manipulation of the treated area for a short period according to clinic protocol.
  • Record product name, batch/lot number, treatment area, injection technique and volumes used, and any immediate reactions in the patient’s medical record using the supplied traceability labels.

Contraindications

  • History of severe allergies or anaphylactic reactions, or presence of multiple severe allergies.
  • Known hypersensitivity to hyaluronic acid, lidocaine, other amide-type local anaesthetics, BDDE or any excipients including gram-positive bacterial proteins.
  • Bleeding disorders or current significant use of anticoagulant, thrombolytic or high-dose antiplatelet therapy where injection-related bleeding risk is considered unacceptable.
  • Active skin disease, inflammation, infection or lesion at or near the intended injection sites (e.g. dermatitis, acne, rashes, bacterial or viral infections).
  • Intravascular injection is strictly contraindicated; the product must not be injected into blood vessels.
  • Intramuscular injection is contraindicated; the product is intended for intradermal use in the superficial to mid dermis.
  • Patients with a known tendency to hypertrophic scarring or keloid formation should generally not be treated with dermal fillers or skin boosters.
  • Use during pregnancy or breastfeeding is not recommended due to insufficient safety data.
  • Use in patients below the minimum age specified in the product labelling and in local regulations (typically adults).

Adverse Effects

  • Common, usually transient injection-site reactions including redness (erythema), swelling, tenderness, pain, itching and bruising.
  • Localized lumps, small papules or nodules at injection points, which usually resolve as the product integrates into the dermis.
  • Injection-site hematoma or ecchymosis, particularly in patients with an increased tendency to bruise or on anticoagulant/antiplatelet therapy.
  • Temporary alterations in sensation such as numbness, tingling or tightness in the treated area due to lidocaine and injection trauma.
  • Localized inflammatory reactions including swelling and redness, which may occur immediately or be delayed and usually resolve spontaneously within days to a few weeks.
  • Infection at or near the injection site, particularly if aseptic technique is not strictly followed.
  • Rare delayed inflammatory reactions, granuloma formation or persistent nodules that may require medical management and in some cases use of hyaluronidase.
  • Rare but serious complications associated with inadvertent intravascular injection, such as vascular occlusion, ischemia, tissue necrosis or visual disturbance, which require urgent medical intervention.
  • Post-inflammatory hyperpigmentation, scarring or other changes in pigmentation and skin texture, particularly in susceptible individuals.
  • Unsatisfactory aesthetic result or asymmetry that may necessitate additional treatments or corrective procedures.

Storage Conditions

  • Store in the original outer carton to protect from light and maintain sterility until use.
  • Store at a controlled temperature, typically between 2°C and 25°C, as indicated on the product packaging and Instructions for Use.
  • Do not freeze; avoid exposure to excessive heat and direct sunlight.
  • Do not use after the expiry date printed on the syringe and outer carton.
  • Do not use if the sterile blister or syringe packaging has been opened or damaged prior to use.

Duration

The average duration of visible results is approximately 3 months after a treatment course, with many patients benefiting from maintenance sessions every 3\u20136 months depending on skin condition, treatment area, technique and individual metabolism.

Onset

Improvement in skin hydration and radiance is typically noticeable soon after treatment, with progressive enhancement of smoothness, elasticity and fine lines over the following days and weeks as the injected hyaluronic acid binds water and integrates into the dermal tissue.

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