DERMALAX PLUS

Dermalax Plus

Dermalax Plus is a monophasic cross-linked hyaluronic acid (HA) dermal filler from Across Co., Ltd. (Hugel group), South Korea. It is the softest gel in the Dermalax range and is designed for the correction of fine facial wrinkles. It contains 20 mg/ml HA and 0.3% lidocaine and is supplied in a 1.1 ml pre-filled syringe. For use by licensed physicians only.

Key Features

• Softest Gel in the Range: Lower HA concentration than Dermalax Deep Plus and Implant Plus, for fine lines.
• Monophasic Gel: A uniform, cohesive cross-linked HA gel, designed for smooth and even injection.
• HA 20 mg/ml: Cross-linked hyaluronic acid gel.
• With 0.3% Lidocaine: Included to help reduce discomfort during injection.
• Fine 30G Needles: Supplied with 30G needles, according to the manufacturer.
• Reversible: Hyaluronic acid can be dissolved with hyaluronidase by a qualified practitioner.

The Dermalax Range

The Dermalax range includes three gels of increasing density. The physician selects the product according to the treatment area, tissue depth and desired result.

• Dermalax Plus: HA 20 mg/ml, 30G needle. The softest gel, for fine facial wrinkles.
• Dermalax Deep Plus: HA 24 mg/ml, 27G needle. For moderate to deep wrinkles and folds.
• Dermalax Implant Plus: HA 24 mg/ml. The densest gel, for volume and contouring in deeper layers.

Intended Use

• Fine facial wrinkles
• Fine perioral lines

Treatment area, injection depth, technique and volume must follow the official Instructions for Use and the treating physician’s assessment. Results and duration vary between individuals.

Product Specifications

• Brand: Dermalax™
• Product: Dermalax Plus
• Manufacturer: Across Co., Ltd. (Hugel group)
• Origin: South Korea
• Composition: Cross-linked hyaluronic acid 20 mg/ml, lidocaine 0.3%
• Gel Type: Monophasic
• Injection Depth: Dermis, as specified in the IFU
• Needle: 30G
• Contents: 1 × 1.1 ml pre-filled syringe, 2 × 30G needles
• Shelf Life: 24 months (refer to the carton for the expiry date)
• Product Type: Hyaluronic acid dermal filler (medical device)

Administration

• For use only by licensed physicians trained in facial anatomy, dermal filler injection techniques and the management of filler complications.
• Inject under aseptic conditions.
• Injection depth, technique, volume and treatment interval must follow the IFU and the treating physician’s judgment.
• Do not self-administer.

Precautions

• Common reactions include redness, swelling, pain, tenderness, itching and bruising at the injection site.
• Lumps, nodules, visible product or bluish discolouration (if placed too superficially), migration, infection and delayed inflammatory reactions may occur.
• Accidental injection into a blood vessel can cause vascular occlusion, skin necrosis and, rarely, visual impairment or blindness.
• Contains lidocaine. Not suitable for people with known allergy to lidocaine or other amide-type local anaesthetics.
• Hyaluronic acid can be dissolved with hyaluronidase. Practitioners should keep hyaluronidase and an emergency protocol available.
• Seek medical attention immediately for severe or increasing pain, skin blanching or colour change, or any change in vision after treatment.
• Do not use if the packaging is damaged, the syringe is cracked or the product is past its expiry date.
• Single use only. One syringe, one patient. Keep out of reach of children.

Who Should Consult a Physician First

• People with known allergy to hyaluronic acid, lidocaine or amide-type local anaesthetics
• Pregnant or breastfeeding women
• People with infection, inflammation, cold sores or skin disease at the treatment area
• People with bleeding disorders or taking medicines that affect blood clotting
• People with autoimmune disease, a history of keloids or severe allergies
• People with permanent fillers or implants in the treatment area
• People under 18 years of age

Storage

Store at 2–25°C. Protect from direct sunlight and freezing. Refer to the carton for the expiry date.

Package Contents

• 1 × 1.1 ml pre-filled syringe of Dermalax Plus
• 2 × 30G needles
• Instructions for Use

Important Notice

For professional healthcare use only. This information is for general product reference. It does not replace medical advice, the official Instructions for Use or local regulations. This product is not intended to diagnose, treat, cure or prevent any disease. Results vary between individuals.