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Juvéderm Volbella

Juvéderm Volbella

Juvederm

Dermal fillers
  • CE Marked sterile injectable hyaluronic acid gel for use as a dermal filler in applicable markets.
  • Manufactured under ISO 13485 Compliant quality management systems for medical devices.
  • Complies with relevant EU/UK medical device regulations for hyaluronic acid dermal fillers.
Hyaluronic acid dermal filler for lips, perioral lines and tear troughs

Description

Juvéderm Volbella with Lidocaine (2 x 1.0 ml) is a cross-linked hyaluronic acid dermal filler specifically formulated for subtle lip enhancement, correction of perioral lines and treatment of infraorbital hollows (tear troughs) and other delicate facial areas. Supplied as two prefilled 1 ml syringes with ultra-fine needles, its soft, smooth gel restores a natural feeling of fullness and hydration while helping to fill fine lines and contour the lips and facial outline. The product contains 15 mg/ml hyaluronic acid of non-animal origin and 0.3% lidocaine in a physiologic phosphate buffer, providing immediate, natural-looking results with improved injection comfort and effects lasting up to about 12 months after the initial treatment.

Bnefits

  • Soft, smooth gel designed for subtle, natural-looking enhancement rather than excessive bulk.
  • Restores gentle volume and definition to the lips while maintaining natural lip movement and feel.
  • Improves perioral lines and fine wrinkles around the mouth for a more youthful smile.
  • Indicated in many markets for infraorbital hollowing (tear troughs) to reduce the appearance of under-eye hollows when injected by suitably trained professionals.
  • Contains 15 mg/ml cross-linked hyaluronic acid to provide durable hydration and volume.
  • Includes 0.3% lidocaine to enhance patient comfort during injection.
  • Supplied with ultra-fine needles (typically 30G or 32G 1/2") for precise application in delicate areas.
  • Biocompatible and biodegradable hyaluronic acid of non-animal origin, gradually resorbed over time.
  • Clinical effects can last up to approximately one year, depending on indication, injection technique and individual patient factors.

Indications

  • Lip augmentation to provide subtle volume and improve definition of the vermilion border and Cupid’s bow.
  • Correction of perioral rhytids (fine lines around the mouth).
  • Improvement of infraorbital hollowing (tear troughs) in appropriately selected adults.
  • Soft correction of superficial facial lines and wrinkles in delicate areas (e.g., around the mouth, chin and lower face).
  • Restoration of a natural feeling of fullness and hydration to areas around the mouth and along the facial outline.

Composition

  • Cross-linked hyaluronic acid gel 15 mg/ml (non-animal origin).
  • Lidocaine (lignocaine) hydrochloride monohydrate 3 mg/ml (0.3% w/w).
  • Phosphate buffer pH 7.2 q.s. to 1 ml.

Formulation

  • Sterile, pyrogen-free, non-pyrogenic, physiological gel of cross-linked hyaluronic acid of non-animal origin.
  • Viscoelastic, clear, colourless, homogeneous gel implant formulated at 15 mg/ml HA with 0.3% lidocaine in a physiologic buffer.
  • Presented in prefilled, single-use, graduated disposable syringes.
  • Non-permanent dermal filler with Vycross technology (short- and long-chain HA cross-linking) for smooth integration and longevity.

Packaging

  • Each box contains two 1 ml prefilled syringes of Juvéderm Volbella with Lidocaine.
  • Four single-use sterile needles (commonly 30G 1/2" or 32G 1/2", depending on region) provided for injection.
  • Instruction leaflet (Directions for Use) included.
  • Set of traceability labels for patient and practitioner records.
  • Syringes and needles packaged in a sterile blister within an outer carton.

Usage

  • For professional use only; must be administered by a suitably trained and licensed healthcare professional experienced in dermal filler injections.
  • Review patient history, indications and contraindications; obtain informed consent prior to treatment.
  • Clean and disinfect the treatment area thoroughly, following strict aseptic technique.
  • Attach one of the supplied sterile needles (e.g., 32G 1/2") or an appropriate cannula to the syringe and expel air before injection.
  • Inject slowly into the appropriate tissue plane depending on the indication: typically intradermal/superficial subdermal for fine lines and lips, and specific depth for infraorbital hollows as per training and product guidelines.
  • Use suitable injection techniques such as serial puncture, linear retrograde threading, cross-hatching or fanning, ensuring small aliquots and low injection pressure.
  • Avoid intravascular injection; aspirate where appropriate and inject carefully in high-risk anatomical regions, especially around the eyes and nasolabial area.
  • Do not overcorrect; build volume gradually and reassess symmetry and contour during the procedure.
  • After injection, gently massage the treated area to ensure even gel distribution and reduce the risk of palpable lumps.
  • Discard any remaining product after treatment; all syringes and needles are single-use and should be disposed of as clinical sharps waste.

Contraindications

  • Known hypersensitivity to hyaluronic acid, lidocaine or any of the excipients.
  • History of severe allergies or anaphylaxis, or presence of multiple severe allergies.
  • Known allergy or intolerance to local anaesthetics of the amide type (such as lidocaine).
  • Active skin or mucosal infection, inflammation, herpes labialis or other dermatological conditions at or near the injection site.
  • Patients with bleeding disorders or on anticoagulant therapy, unless the treating physician determines that benefits outweigh risks.
  • History of hypertrophic scarring or keloid formation in the proposed treatment area.
  • Autoimmune diseases or immunosuppressive therapy where dermal filler use may pose additional risks, unless carefully evaluated by the physician.
  • Pregnancy and breastfeeding, due to lack of adequate safety data in these populations.

Adverse Effects

  • Common local reactions such as redness, swelling, tenderness, pain, itching, bruising or discolouration at the injection site, usually resolving within a few days.
  • Temporary lumps, papules, nodules or irregularities which often improve with massage and as the gel integrates into tissue.
  • Haematoma or prolonged bruising, particularly in highly vascular areas such as the lips and tear trough.
  • Transient firmness or induration in the treated area.
  • Rare inflammatory reactions including persistent nodules or granuloma formation.
  • Rare hypersensitivity or allergic reactions to hyaluronic acid, lidocaine or other components.
  • Very rare but serious complications related to inadvertent intravascular injection, including vascular occlusion, skin necrosis, visual disturbance or blindness, particularly when injecting near arteries.
  • Risk of local infection, abscess or biofilm formation if aseptic technique is not observed.
  • Possible reactivation of herpes labialis in predisposed individuals when treating the lip area.

Storage Conditions

  • Store in the original packaging in a clean, dry place.
  • Maintain storage temperature typically between 2°C and 25°C as indicated on the outer carton; do not freeze.
  • Protect from direct sunlight and excessive heat.
  • Do not use if the blister, syringe or needles are damaged or previously opened.
  • Do not use after the expiry date printed on the carton and syringe labels.

Duration

Clinical effects usually appear immediately after injection and, according to clinical studies and product literature, can last up to about 12 months following an initial treatment course, with maintenance or touch-up sessions scheduled according to individual response and practitioner assessment.

Onset

Visible improvement in lip fullness, line reduction and contour is typically immediate after injection, with final results becoming more evident as transient swelling and redness subside over the following days.

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