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Juvéderm Ultra

Juvéderm Ultra

Juvederm

Dermal 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 is a cross-linked hyaluronic acid dermal filler with lidocaine, specifically formulated for lip augmentation and rejuvenation of the perioral area. It is a lip-focused variant of Juvéderm Ultra 3, designed to add soft, natural-looking volume, define lip contours, correct asymmetry and smooth fine lines around the mouth. The gel contains 24 mg/ml of non-animal hyaluronic acid combined with 0.3% lidocaine for improved injection comfort. The standard Allergan pack contains two prefilled 0.55 ml syringes intended for precise work on the lips and surrounding areas; Derma Filler Ltd lists the product as a 2x1 ml presentation in a wholesale offer.

Bnefits

  • Provides soft, natural-looking lip volume and enhancement tailored specifically for the lips and mouth area.
  • Redefines and sharpens lip borders and Cupid’s bow while helping to correct upper–lower lip asymmetry.
  • Smooths vertical lip lines and fine wrinkles around the mouth, contributing to a more youthful smile.
  • High hyaluronic acid concentration (24 mg/ml) offers durable yet moldable volume and hydration.
  • Contains 0.3% lidocaine to reduce pain and discomfort during injections.
  • Cross-linked, non-animal hyaluronic acid gel that is biocompatible and biodegradable.
  • Packaged in smaller syringes for refined control and reduced product waste in lip-specific treatments.

Indications

  • Lip augmentation to increase upper and/or lower lip volume.
  • Redefinition and enhancement of lip contour and Cupid’s bow.
  • Correction of perioral (vertical) lip lines and fine wrinkles around the mouth.
  • Lifting and softening of corner lines and oral commissures to improve overall smile aesthetics.
  • 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 (vehicle) q.s. 1 ml.

Formulation

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

Packaging

  • Manufacturer standard box: two prefilled 0.55 ml syringes of Juvéderm Ultra Smile.
  • Two single-use sterile 30G 1/2" needles supplied for injection.
  • Instruction leaflet (Directions for Use) included in each box.
  • Traceability labels for patient and practitioner records.
  • Derma Filler Ltd wholesale listing describes the product as Juvederm Ultra Smile (2x1ml), typically referring to bundled or approximate total volume while standard syringes remain 0.55 ml each.

Usage

  • For professional use only; must be injected by an appropriately trained medical or aesthetic practitioner.
  • Assess patient medical history, lip anatomy and aesthetic goals; obtain informed consent prior to treatment.
  • Clean and disinfect the treatment area according to local aseptic protocols.
  • Attach the supplied sterile 30G 1/2" needle (or equivalent recommended by the manufacturer) to the prefilled syringe and expel air before injection.
  • Inject slowly into the lip mucosa 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, depending on the area and desired result.
  • Avoid intravascular injection; aspirate according to training and inject with minimal pressure.
  • Shape and gently massage the lips after injection to ensure even distribution and smooth contours.
  • Do not overcorrect; add volume gradually and reassess symmetry, proportion and profile throughout the procedure.
  • Typical total volume per session varies according to individual anatomy and goals; touch-up sessions may be performed if required.
  • Syringes and needles are single-use only; discard any remaining product and used devices as clinical sharps waste.

Contraindications

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

Adverse Effects

  • Common and transient 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 with massage and as the gel integrates into the tissue.
  • Haematoma or prolonged bruising in some patients, particularly when treating highly vascular lip tissue.
  • Rare inflammatory reactions including induration, nodules or granuloma formation.
  • Rare hypersensitivity or allergic reactions to hyaluronic acid, lidocaine or other components.
  • Very rare but serious complications associated with inadvertent intravascular injection, such as vascular occlusion, tissue necrosis or visual disturbances.
  • Risk of local infection 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 packaging, blister or syringe is damaged or previously opened.
  • Do not use after the expiry date printed on the carton and syringe labels.

Duration

Clinical results are typically visible immediately and can last up to approximately 12 months in the lips and perioral area, depending on patient metabolism, injection technique, treated area and lifestyle factors.

Onset

Improvement in lip volume, contour and fine lines is usually visible immediately after injection, with final results settling over several days as transient swelling and redness subside.

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