Restylane Classic with Lidocaine (1 x 1.0 ml)
Restylane
Injectable Medical DeviceHyaluronic Acid Dermal Filler
Certifications
- CE Marked medical device in accordance with Directive 93/42/EEC (MDD) for Restylane Lidocaine and associated needles
- Manufactured using non Animal stabilized hyaluronic acid (NASHA technology)
- Part of the Restylane dermal filler portfolio, which includes FDA Approved formulations for specific aesthetic indications in relevant markets
- Produced under quality systems compliant with applicable medical device regulations and standards
- CE Marked medical device in accordance with Directive 93/42/EEC (MDD) for Restylane Lidocaine and associated needles
- Manufactured using non Animal stabilized hyaluronic acid (NASHA technology)
- Part of the Restylane dermal filler portfolio, which includes FDA Approved formulations for specific aesthetic indications in relevant markets
- Produced under quality systems compliant with applicable medical device regulations and standards
Hyaluronic Acid Dermal Filler
Description
Restylane Classic with Lidocaine is a hyaluronic acid (HA) dermal filler from the Restylane portfolio designed for facial tissue augmentation. Using stabilized, non-animal HA at 20 mg/mL with 0.3% lidocaine, it restores volume, smooths moderate facial wrinkles and folds, and enhances lips while improving patient comfort during treatment. The gel has an intermediate particle size, is injected into the mid-dermis or submucosal layer of the lip, and provides natural-looking, long-lasting results that can persist for around 6–12 months depending on the indication, injection technique, and individual patient factors.
Bnefits
- Smooths moderate facial wrinkles and folds such as nasolabial folds, marionette lines, and glabellar lines
- Restores and subtly enhances lip volume for a more youthful, defined smile
- Provides gentle volumization and contouring for areas such as cheeks and midface
- Contains 0.3% lidocaine to reduce injection pain and improve patient comfort
- Intermediate gel particle size designed for balanced lift, support, and natural integration into tissue
- Stabilized, non-animal hyaluronic acid (NASHA technology) for predictable, consistent outcomes
- Single-use, sterile, CE-marked medical device with traceability labels for patient records
- Clinically demonstrated durability, with improvements typically maintained for 6–12 months
- Versatile filler suited to a range of aesthetic indications in the mid-dermis and lip submucosa
- Produced by Galderma, a long-established global dermatology and aesthetics manufacturer
Indications
- Facial tissue augmentation for aesthetic purposes in adults, performed by appropriately trained healthcare professionals
- Correction of moderate facial wrinkles and folds (e.g., forehead lines, glabellar lines, nasolabial folds, marionette lines)
- Lip enhancement and restoration of lip volume via submucosal injection
- Subtle cheek and midface volumization in areas appropriate for a mid-dermal HA filler
- Treatment of lines around the mouth, nose, and eyes where a medium-firm HA gel is suitable
- Use only as specified in the official Instructions for Use and in accordance with local regulations
Composition
- Stabilized hyaluronic acid (non-animal origin): 20 mg/mL
- Lidocaine hydrochloride: 3 mg/mL (0.3% lidocaine)
- Phosphate buffered saline q.s.
- Sterile, transparent, biodegradable gel supplied in a glass syringe
- Disposable 29G thin-walled needles supplied in the pack (needle gauge may vary by market)
Formulation
- Stabilized, non-animal hyaluronic acid gel (NASHA technology) at 20 mg/mL with integrated 0.3% lidocaine hydrochloride in phosphate buffered saline, supplied as a sterile, single-use, pre-filled glass syringe for injection into the mid-dermis or lip submucosa.
Packaging
- 1 x 1.0 mL pre-filled glass syringe of Restylane Classic with Lidocaine
- Typically supplied with 2 x 29G thin-walled disposable needles (needle specification may vary by market)
- Syringe fitted with luer-lock adapter and tamper-evident cap
- Outer carton printed with Restylane and Galderma branding, batch number, and expiry date
- Patient record labels included on syringe label for traceability in medical records
- Single-use, sterile packaging; not to be resterilized or reused
Usage
- For professional use only: this product must be administered exclusively by appropriately trained and legally authorized healthcare professionals familiar with facial anatomy and dermal filler injection techniques.
- Before use, inspect the outer carton, blister, and syringe; do not use if any packaging is damaged or if the product is past its expiry date.
- Perform a full medical history including allergies (especially to lidocaine or amide-type local anaesthetics), bleeding disorders, autoimmune conditions, and previous filler or implant procedures.
- Prepare the treatment area with appropriate skin antisepsis following local infection-prevention protocols.
- Assemble the needle to the luer-lock syringe according to the Instructions for Use, ensuring the needle is firmly attached and secure.
- Inject slowly using aseptic technique into the mid-dermis for wrinkle correction or into the submucosal layer for lip augmentation, aspirating carefully before each injection to reduce the risk of intravascular placement.
- Use small aliquots of product and massage gently if needed to achieve an even distribution and smooth contour, taking care not to overcorrect.
- Avoid intravascular or intramuscular injection; if blanching or signs of vascular compromise occur, stop injecting immediately and manage according to current clinical guidance.
- After treatment, provide the patient with post-procedure instructions (e.g., avoid makeup on the treated area for several hours, avoid extreme temperatures, intense exercise, and manipulation of the area for a specified period).
- Record batch number, injection sites, volume used, and any immediate reactions in the patient’s medical record, attaching the patient record label from the syringe.
Contraindications
- Known hypersensitivity or allergy to hyaluronic acid, lidocaine, or other amide-type local anaesthetics, or to any component of the product
- Patients with a history of severe allergies or anaphylaxis, or multiple severe allergies
- Injection into or near areas with active skin disease or infection (e.g., inflammation, herpes simplex, acne flares) at or near the intended treatment site
- Intravascular or intramuscular injection (product is intended for intradermal or submucosal use only)
- Patients with bleeding disorders or those receiving thrombolytics, anticoagulants, or high-dose antiplatelet therapy where the risk of injection-related bleeding is unacceptable
- Use in patients with known tendency to hypertrophic scarring or keloid formation should be carefully considered and is generally discouraged
- Use during pregnancy or breastfeeding is not recommended due to lack of sufficient safety data
- Use in patients under the age specified by local regulations and product labelling (commonly adults 18+; some lip indications 21+ in certain markets)
Adverse Effects
- Common, usually transient injection-site reactions such as redness, swelling, pain, tenderness, itching, bruising, or mild erythema
- Local induration, nodules, lumps, or irregularities at the injection site
- Injection-site hematoma or ecchymosis
- Temporary changes in sensation (e.g., numbness, tingling) due to lidocaine or injection trauma
- Inflammatory reactions such as redness, swelling, or discomfort that may appear immediately or be delayed by days to weeks
- Infection at the injection site if aseptic technique is not strictly followed
- Rare but serious events such as vascular occlusion, ischemia, necrosis, or visual disturbance if product is inadvertently injected into or compresses a blood vessel
- Hypersensitivity reactions, including very rare cases of severe allergic or anaphylactic responses
- Post-inflammatory hyperpigmentation, particularly in patients with darker skin types
- Very rare granulomatous reactions or persistent inflammatory responses that may require medical management or product removal
Storage Conditions
- Store in accordance with the manufacturer’s instructions on the outer packaging.
- Keep in a clean, dry place away from direct sunlight and excessive heat.
- Do not freeze; avoid extreme temperatures.
- Keep in the original carton until use to protect from light and physical damage.
- Do not use after the expiry date printed on the packaging.
- Do not use if any part of the sterile packaging is damaged or previously opened.
Duration
Clinical improvement typically lasts approximately 6\u201312 months, depending on treatment area, injection technique, and individual patient factors. Some patients may require earlier touch-up or maintenance treatments as determined by the treating clinician.
Onset
Visible improvement is usually immediate after injection, with final results evident once initial swelling and redness resolve over several days to about 2 weeks.
