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Juvéderm Ultra Smile 2 x 0.55 ml

Juvéderm Ultra Smile 2 x 0.55 ml

Juvederm

DERMA FILLERS
  • CE Marked sterile injectable hyaluronic acid gel for use as a dermal filler.
  • Manufactured under ISO 13485–compliant quality management systems for medical devices.
  • Conforms to applicable EU/UK medical device regulations for hyaluronic acid dermal fillers.
Hyaluronic acid lip filler with lidocaine

Description

Juvéderm Ultra Smile 2 x 0.55 ml is a cross-linked hyaluronic acid dermal filler with lidocaine, specifically formulated for lip augmentation and rejuvenation of the perioral area. As a lip-focused member of the Juvéderm Ultra range, it is designed to create natural-looking lip volume, enhance and redefine lip shape, improve oral commissures, and smooth fine lines around the mouth. The gel contains 24 mg/ml non-animal hyaluronic acid with 0.3% lidocaine to provide a comfortable injection experience. The product is supplied as two prefilled 0.55 ml syringes intended for precise work on the lips and surrounding areas and must be injected by a certified medical professional.

Bnefits

  • Specially formulated for the lips and mouth area to achieve soft, natural-looking volume and definition.
  • Creates and enhances lip volume while maintaining a natural proportion between the upper and lower lips.
  • Redefines lip contours and Cupid’s bow, improving overall lip shape.
  • Smooths fine lines and wrinkles around the mouth to rejuvenate the smile area.
  • High hyaluronic acid concentration (24 mg/ml) provides durable yet moldable volume and hydration.
  • Contains 0.3% lidocaine to reduce pain and discomfort during injection.
  • Cross-linked, non-animal hyaluronic acid gel that is biocompatible and biodegradable.
  • Packaged in smaller 0.55 ml syringes for precise dosing and reduced product waste in lip-specific treatments.

Indications

  • Creation of lip volume.
  • Enhancement of the mouth area and oral commissures.
  • Redefinition and shaping of lip contours and Cupid’s bow.
  • Correction of fine lines and wrinkles around the mouth.
  • General lip rejuvenation where improved hydration, definition and soft volume are desired.

Composition

  • Cross-linked hyaluronic acid (HA) of non-animal origin, 24 mg/ml.
  • Lidocaine hydrochloride 0.3% (3 mg/ml) as a local anaesthetic.
  • Phosphate buffer solution, pH approximately 7.2, q.s. to 1 ml.

Formulation

  • Sterile, pyrogen-free, physiological gel of cross-linked hyaluronic acid of non-animal origin.
  • Transparent, viscoelastic injectable gel prefilled in graduated single-use syringes.
  • Premixed with lidocaine to enhance patient comfort during treatment.
  • Non-permanent dermal filler intended for intradermal and/or mucosal injection in the lips and perioral region.

Packaging

  • Box containing 2 prefilled syringes of 0.55 ml each (total 1.1 ml).
  • 2 sterile 30G 1/2" single-use needles supplied for injection (needle configuration may vary slightly by market).
  • Instruction leaflet (Directions for Use) included in each box.
  • 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 certified medical or aesthetic practitioner experienced in dermal filler injections.
  • Assess the patient’s medical history, lip anatomy and aesthetic goals and obtain informed consent before treatment.
  • Thoroughly cleanse and disinfect the treatment area according to local aseptic protocols.
  • Attach a sterile 30G 1/2" needle to the prefilled syringe and expel air before injection.
  • Inject slowly into the lip mucosa and/or superficial to mid dermis of the lips and perioral area using appropriate techniques such as serial puncture, linear retrograde threading, anterograde tracing, cross-hatching or fan distribution.
  • Avoid intravascular injection; aspirate according to training where appropriate and inject with minimal pressure.
  • Build volume gradually and symmetrically, assessing lip proportion and profile throughout the procedure; do not overcorrect.
  • After injection, gently massage the treated areas to ensure even gel distribution and smooth contours.
  • Typical total volume per session depends on individual anatomy and desired correction; touch-up treatments may be performed as needed.
  • Dispose of any unused product, needles and syringes as clinical sharps waste after a single treatment session; do not resterilise or reuse.

Contraindications

  • Known hypersensitivity to hyaluronic acid, lidocaine, or any component of the product.
  • History of severe allergic reactions or anaphylaxis.
  • Known allergy to local anaesthetics of the amide type (e.g., lidocaine).
  • Active infection, inflammation, herpes labialis, or other skin/mucosal disease in or near the intended treatment area.
  • Autoimmune disease or immunosuppressive therapy where dermal fillers may pose additional risks, unless the treating physician judges the benefits to outweigh the risks.
  • History of hypertrophic scarring or keloids in the treatment area.
  • Use during pregnancy or breastfeeding, due to insufficient safety data.
  • Recent deep chemical peels, laser resurfacing or dermabrasion in the same area without adequate recovery time and clinical assessment.

Adverse Effects

  • Common injection-site reactions such as redness, swelling, tenderness, pain, itching, bruising or discolouration, usually resolving within a few days.
  • Temporary lumps, bumps or irregularities that generally improve as the gel integrates and with light massage.
  • Haematoma or prolonged bruising, particularly in the highly vascular lip region.
  • Rare inflammatory reactions, including induration, nodules or granuloma formation.
  • Rare hypersensitivity or allergic reactions to hyaluronic acid, lidocaine or other excipients.
  • Very rare but serious complications associated with inadvertent intravascular injection, including vascular occlusion, tissue necrosis or visual disturbances.
  • Local infection at the injection site if aseptic technique is not strictly followed.

Storage Conditions

  • Store in the original unopened packaging at a controlled temperature between 2°C and 25°C.
  • Do not freeze.
  • Protect from direct sunlight and excessive heat.
  • Do not use if the blister, carton or syringe is damaged or previously opened.
  • Do not use after the expiry date printed on the packaging and syringe labels.

Duration

Results are typically visible immediately and can last for up to approximately 12 months in the lips and perioral area, depending on the patient\u2019s metabolism, lifestyle, treated area and injection technique.

Onset

Improvement in lip volume, contour and fine lines is usually visible immediately after injection, with final results becoming more apparent over several days as swelling subsides and the gel integrates into the tissue.

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