JUVEDERM® ULTRA SMILE with Lidocaine

Manufacturing Information for Juvéderm Ultra Smile

Juvéderm Ultra Smile is manufactured by Allergan, a global leader in aesthetic and medical treatments. 

Medical professionals can purchase the complete Juvéderm range through Kinami Health:

• Juvéderm Voluma with Lidocaine: Restores lost facial volume, particularly in the cheeks.
• Juvéderm Ultra 3: Smooths moderate to deep wrinkles and enhances facial contours.
• Juvéderm Volbella with Lidocaine: Ideal for subtle lip enhancement and treating fine lines.
• Juvéderm Volift with Lidocaine: Improves midface volume loss and refines facial contours.
• Juvéderm Ultra 2: Targets fine lines and superficial wrinkles.
• Juvéderm Volux with Lidocaine: Designed for jawline definition and structural support.
• Juvéderm Volite with Lidocaine (Skinvive): Enhances skin hydration and elasticity.
• Juvéderm Ultra 4: Treats severe facial wrinkles and deeper folds.
• Juvéderm Volift Retouch with Lidocaine: Designed for subtle refinements and touch-ups.

Expected Benefits and Results of the Treatments

Juvéderm Ultra Smile provides long-lasting, natural-looking results with minimal downtime:

• Fuller lips: Enhances lip volume while maintaining a natural shape.
• Defined lip contours: Improves the shape and symmetry of the lips.
• Hydration boost: Keeps lips smooth, soft, and plump.
• Reduced perioral wrinkles: Softens fine lines around the mouth.
• Comfortable treatment: Lidocaine ensures a pain-free experience.
• Long-lasting effects: Last for several months, depending on individual metabolism.
• Balanced and symmetrical lips: Corrects asymmetry for a more even, proportional appearance.
• Soft and natural feel: The smooth gel formula integrates seamlessly with lip tissue.
• Quick procedure with minimal downtime: Treatment is fast and allows patients to resume normal activities shortly after.

Juvéderm Ultra Smile Key Ingredients and Device Properties

Juvéderm Ultra Smile is formulated with key ingredients to ensure safety and effectiveness.

Active ingredients:

• Hyaluronic acid gel: 24 mg – Hydrates and volumises the lips.
• Lidocaine hydrochloride: 3 mg – Reduces pain during treatment.
• Phosphate buffer pH 7.2 q.s: 1 ml – Ensures product stability.

Device properties:

• Optimised syringe design: Ensures precise application with minimal wastage.
• Smooth-flow technology: Enhances injection control, reducing resistance and improving practitioner handling.
• Long-lasting formulation: Provides durable results while maintaining flexibility in the treated area.

Included Items or Accessories

Each package contains all necessary components for safe administration:

• Two pre-filled 0.55 ml syringes.
• Two 30G1/2” sterilized needles.
• Detailed product information.
• Traceability labels.

Administration Method for Juvéderm Ultra Smile

Medical professionals should follow these steps for safe and effective application:

Pre-procedure:

• Assess the patient’s medical history.
• Cleanse and disinfect the treatment area.
• Apply a topical anaesthetic if needed.

During procedure:

• Inject using a fine-gauge needle at the appropriate depth.
• Use a gentle, even technique to distribute the filler.
• Massage the area to ensure even distribution.

After procedure:

• Provide patients with post-treatment care instructions.
• Advise on expected swelling and recovery time.

Guidelines for Proper Aftercare

Patients should follow these aftercare steps for optimal results:

• Avoid touching or massaging the treated area for 24 hours.
• Refrain from excessive sun exposure, saunas, and intense exercise for 48 hours.
• Stay hydrated to support healing.
• Avoid alcohol and blood-thinning medications for 24 hours.

Potential Risks and Side Effects

While generally well-tolerated, some side effects may occur.

Common side effects:

• Swelling and bruising at the injection site.
• Temporary redness or sensitivity.
• Mild discomfort during the procedure.
• Nerve irritation or tingling.

Rare side effects:

• Lumps or uneven distribution.
• Allergic reactions to lidocaine.
• Infection at the injection site.
• Formation of granuloma. 
• Vascular occlusion.

Juvéderm Ultra Smile Treatment Contraindications

Not all patients are suitable candidates for Juvéderm Ultra Smile:

• Pregnant or breastfeeding women: Safety has not been established, and hormonal changes may affect results.
• Patients with active skin infections: Increases risk of complications and delayed healing.
• Individuals with severe allergies: Risk of hypersensitivity reactions, particularly to lidocaine or hyaluronic acid.
• Autoimmune disorder patients: May experience unpredictable results or heightened immune responses.
• Patients taking blood-thinning medication: Increased risk of excessive bruising and prolonged healing.
• Individuals with a history of keloid or hypertrophic scarring: Higher likelihood of abnormal scar formation.
• Those with uncontrolled diabetes: May have impaired wound healing and increased infection risk.
• Patients with neurological disorders affecting facial muscles: Could impact the effectiveness of the treatment.
• Individuals with hypersensitivity to local anaesthetics: Risk of allergic reactions to lidocaine.
• People undergoing laser treatments or chemical peels: Increased skin sensitivity and risk of irritation when combined with fillers.
• Patients with compromised immune systems: Higher risk of infection and adverse reactions.