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Juvederm Ultra Smile

Juvederm Ultra Smile

Juvederm

Derma fillers
  • CE Marked Class III medical device for the correction of medium and/or deep skin depressions and for lip definition and enhancement
  • Manufactured under a medical device quality management system compliant with EU/EEA regulatory requirements for injectable HA implants
  • Non Animal, cross Linked hyaluronic acid with lidocaine, conforming to Allergan/AbbVie safety and performance standards
Hyaluronic acid lip filler for lip augmentation and perioral lines

Description

Juvederm Ultra Smile is a hyaluronic acid dermal filler specifically designed for the lips and surrounding mouth area. As a dedicated variation of Juvederm Ultra 3, it is formulated to restore lost volume, enhance lip shape and definition, lift the corners of the mouth and smooth fine lines and wrinkles on and around the lips. The product is supplied as two 0.55 ml prefilled syringes and contains cross-linked, non-animal hyaluronic acid at 24 mg/ml with 0.3% lidocaine to improve injection comfort. It is used by trained medical professionals to create soft, natural-looking lip augmentation and perioral rejuvenation.

Bnefits

  • Specifically formulated for lip enhancement and perioral rejuvenation, offering tailored rheology for the mouth area
  • Increases lip volume while maintaining a soft, natural look and feel
  • Redefines lip contours and Cupid’s bow for a more defined smile
  • Helps lift the corners of the mouth and smooth fine lines and vertical ‘smoker’s lines’ around the lips
  • Contains 0.3% lidocaine to reduce pain and improve patient comfort during injection
  • Cross-linked hyaluronic acid (24 mg/ml) provides durable yet reversible results
  • Non-animal, biodegradable HA minimises risk of allergic reactions and integrates smoothly with tissue
  • Results are immediate and can last from around 6–12 months in most patients, with some reports of longer duration depending on individual factors

Indications

  • Lip volume enhancement (plumping and augmentation of upper and/or lower lip)
  • Redefinition and contouring of the lip border and Cupid’s bow
  • Correction of asymmetries between the lips
  • Lifting and support at the oral commissures (corners of the mouth)
  • Softening and filling of medium to deep perioral lines (e.g. vertical lip lines or ‘smoker’s lines’)
  • General rejuvenation of the mouth area for a more youthful smile

Composition

  • Cross-linked hyaluronic acid 24 mg/ml (non-animal origin, produced by Streptococcus bacteria fermentation)
  • Lidocaine hydrochloride 3 mg/ml (0.3% w/w) as a local anaesthetic
  • Phosphate buffer, pH approximately 7.2
  • Water for injection and standard excipients as per official instructions for use

Formulation

  • Sterile, pyrogen-free, physiological gel of cross-linked hyaluronic acid of non-animal origin
  • HA concentration: 24 mg/ml with 0.3% lidocaine
  • Smooth, transparent injectable gel designed for lip and perioral tissue integration
  • Intended injection depth: mid to deep dermis and lip mucosa (vermillion)
  • Single-use prefilled, graduated glass syringes (0.55 ml each) with luer-lock connection
  • Pack presentation: 2 x 0.55 ml syringes per box, supplied with single-use 30G 1/2" needles

Packaging

  • Box containing: 2 x 0.55 ml prefilled syringes of Juvederm Ultra Smile
  • Typically supplied with 2 sterile 30G 1/2" single-use needles designed specifically for injecting Juvederm Ultra Smile
  • Includes instructions for use (IFU) and a set of traceability labels for patient records
  • Each syringe individually blister-packed in a sterile tray within the outer carton

Usage

  • For use only by appropriately trained and qualified healthcare professionals experienced in dermal filler injection techniques.
  • Take a full medical history, assess indications and exclude contraindications before treatment; obtain informed consent.
  • Cleanse and disinfect the treatment area (lips and perioral region) according to standard aseptic protocols.
  • Juvederm Ultra Smile is indicated for injection into the mid to deep dermis and the mucous membrane of the lips.
  • Use the supplied 30G 1/2" needle; inject slowly using appropriate techniques such as linear threading, serial puncture or fanning to build volume and define contours.
  • Avoid overcorrection; treatment can be refined or topped up at a subsequent visit if needed.
  • After injection, gently massage the treated area to ensure even distribution and a smooth contour if required.
  • Advise the patient to avoid makeup on the treated area for several hours and to refrain from intense heat (sauna, sunbeds), vigorous exercise and alcohol for 24 hours post-procedure.
  • Instruct the patient to report any unusual pain, blanching, vision changes, or signs of infection immediately.
  • Dispose of used syringes, needles and any remaining gel in accordance with local sharps and clinical waste regulations; do not resterilise or reuse.

Contraindications

  • Hypersensitivity to hyaluronic acid, lidocaine, amide-type local anaesthetics, or any component of the formulation
  • Known hypersensitivity to Gram-positive bacterial proteins (source of HA production)
  • Untreated epilepsy
  • Patients with a tendency to develop hypertrophic scars or keloids
  • Porphyria
  • Pregnancy or breastfeeding
  • Children and adolescents (product is intended for adults)
  • Active inflammatory or infectious skin conditions in the proposed treatment area (e.g. acne, herpes labialis/cold sores)
  • Use in the periorbital (eyelids, crow’s feet) and glabellar regions is specifically contraindicated
  • Injection into blood vessels (intravascular injection) is strictly contraindicated due to risk of serious complications

Adverse Effects

  • Common, usually transient injection-site reactions such as redness, swelling, tenderness, pain, bruising, itching or discolouration at the treated area
  • Temporary lumps, bumps or firmness at the injection sites, generally resolving within days to weeks
  • Rare inflammatory reactions or hypersensitivity responses, including prolonged swelling or induration
  • Very rare but serious complications from inadvertent intravascular injection, including embolisation, vascular occlusion, tissue ischaemia or necrosis, and potential visual disturbances
  • Risk of infection at injection sites if aseptic technique and aftercare are not strictly followed

Storage Conditions

  • Store in the original packaging in a clean, dry place at controlled room temperature as specified on the carton (typically between 2 °C and 25 °C).
  • Protect from freezing and from excessive heat or direct sunlight.
  • Keep syringes in their sterile blister packaging until immediately before use.
  • Do not use after the expiry date printed on the packaging or if the blister or syringe appears damaged.

Duration

Results are typically immediate and, depending on individual factors and injection technique, commonly last around 6\u201312 months; some clinical and commercial sources report durations up to approximately 12\u201318 months before retreatment is required.

Onset

Immediate visible improvement in lip volume and contour following injection, with optimal integration and softening of results over the subsequent days to weeks as any swelling subsides.

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