Kelo-Cote (Gel) Instructions for Use

Marketing Authorization Holder

Advanced Bio-Technologies, Inc. (USA)

Contact Information

BIOCODEX LLC (Russia)

Dosage Form

Kelo-Cote

Gel: 6 g or 15 g tubes

Dosage Form, Packaging, and Product Composition

Gel based on silicone.

The gel formula is patented¹.

Composition polysiloxane, silicon dioxide.

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

¹ U.S. Patent No. 5,741,509
European Patent No. 1439866, 1409034

Therapeutic Category

Medical device for scar resolution

Properties

Kelo-Cote is a silicone-based gel for preventing the formation and reducing the severity of keloid and hypertrophic scars resulting from surgical interventions, injuries, wounds, and burns, as well as for improving the aesthetic appearance of scars.

Kelo-Cote dries quickly, forming an elastic, water-resistant, and breathable film on the skin. When Kelo-Cote gel is applied to a scar, it forms a protective barrier at the application site, which helps reduce chemical, physical, and bacterial exposure while maintaining the skin’s water balance. This creates conditions for the normalization of collagen synthesis processes, prevents the scar from growing, and improves the appearance of the scar itself.

After using Kelo-Cote, the severity of keloid and hypertrophic scars, itching, and discomfort are reduced; color is restored; scars become smoother and softer, and their aesthetic appearance improves.

According to International Clinical Guidelines for Scar Therapy, silicone was recommended as the first line of therapy for all types of scars and a mandatory element for preventing the formation and reducing the severity of keloid and hypertrophic scars.

Kelo-Cote can be applied to the skin in the area of joints, on flexion sites, on areas with hair growth, and on large scar surfaces resulting from burns and extensive injuries.

Kelo-Cote can be used with pressure bandages or other auxiliary means.

Scope of Application

Of the Kelo-Cote product

• For preventing the formation, reducing the severity, and improving the aesthetic appearance of both old and fresh scars (including hypertrophic and keloid), resulting from surgical interventions, injuries, wounds, and burns.

ICD codes

Dosage Regimen

The Kelo-Cote product is intended for external use only.

Before using the product, it is necessary to ensure that the skin on the affected area is clean and dry, then apply Kelo-Cote in a continuous thin layer and allow it to dry.

Kelo-Cote should be applied 2 times/day. For maximum effect, Kelo-Cote should be in contact with the skin for 24 hours.

After the gel has completely dried, sunscreen and cosmetic products can be applied, and pressure bandages can be used.

If Kelo-Cote does not dry within 4-5 minutes, the gel may have been applied too thickly. In this case, carefully remove the excess and allow the remaining gel to dry.

The recommended duration of gel application is at least 60-90 days. For large and old scars, a longer course of application may be required. Further application of the gel is recommended if improvement in the scar’s appearance continues to be observed after the first 90 days of use.

The complete drying time of Kelo-Cote gel depends on the temperature difference between the gel and the skin. To reduce drying time in a hot climate, Kelo-Cote should be stored in the refrigerator. To reduce the drying time of the gel in cold weather, a hair dryer can be used (medium temperature setting).

Contraindications

No contraindications have been identified.

Special Instructions

Kelo-Cote is suitable for children and people with sensitive skin.

Avoid getting the gel into the eyes, on mucous membranes, and in open wounds.

If the Kelo-Cote gel does not dry completely, it may stain clothing.

If skin irritation occurs, discontinue use of the gel and consult a doctor.

Storage Conditions

Kelo-Cote should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 4 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.