Dermatix (Gel) Instructions for Use

Marketing Authorization Holder

Meda Pharmaceuticals Switzerland, GmbH (Switzerland)

Manufactured By

Hanson Medical, Inc. (USA)

Dosage Form

Dermatix

Silicone gel: tubes 6 g, 15 g, or 60 g

Dosage Form, Packaging, and Product Composition

Silicone gel for topical use, transparent, colorless and odorless.

Composition a mixture of polymeric silicone compounds (polysiloxanes).

6 g – thermoplastic tubes (1) – cardboard packs.
15 g – thermoplastic tubes (1) – cardboard packs.
60 g – thermoplastic tubes (1) – cardboard packs.

Properties

Dermatix is a silicone gel for preventing scar formation immediately after wound healing and for correcting immature raised scars.

It helps maintain uniform skin hydration and has a corrective effect on scars resulting from injuries, burns, surgeries, and other skin damage.

It has the ability to smooth and soften raised scars, alleviate associated pain, itching, and discomfort, and reduce skin redness.

It is easily applied to all areas of the skin, including the face, joints, and folds, dries quickly, and forms an invisible protective film.

Scope of Application

Of the Dermatix product

• For the treatment and prevention of hypertrophic and keloid scars (after surgeries, burns, or other injuries) at early stages immediately after wound healing;
• For the treatment of raised immature red scars that are in the process of formation and up to 2 years after wound closure.

ICD codes

Dosage Regimen

Topically. The gel should be applied 2 times/day (morning and evening).

The minimum duration of the preventive course is at least 2 months; in case of complicated scarring, longer use may be required.

Method of application

Remove the tube cap and cut off the tip. For the 60 g tube, it is sufficient to simply remove the protective film.

The treated area of skin should be washed with water and dried thoroughly. Dermatix should be applied only to clean and dry skin. Gently massage a small amount of the gel into the scar using soft circular motions. If too much gel is applied, the excess should be removed with a tissue to avoid staining clothing. After the Dermatix gel has completely dried, cosmetic products can be applied.

Side Effects

In rare cases, application of the gel may cause redness, pain, or skin irritation.

If side effects develop or other undesirable manifestations are noted, the patient should consult their doctor.

Contraindications

Dermatix should not be used on open, unhealed wounds.

Special Precautions

Avoid getting the gel on the mucous membranes and on areas of skin in close proximity to the eyes.

Dermatix should not be applied over any dermatological preparations without consulting a doctor.

Dermatix can be used in pediatric practice.

Storage Conditions

Dermatix should be stored out of the reach of children at a temperature not exceeding 25°C (77°F); away from heat sources.

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.