KELO-COTE® Gel

Scar treatment and prevention gel Kelo-Cote Gel
ADVANCED FORMULA SCAR TREATMENT

KELO-COTE® Gel is a lightweight, transparent, self-drying silicone gel for the treatment of scars.

KELO-COTE® Gel rapidly dries to form a flexible, waterproof sheet which forms a protectivebarrier against chemical, physical and microbial invasion of the scar site while assisting with hydration. This creates an environment which allows the scar to mature through normalised collagen synthesis and helps improve the physiological and cosmetic appearance of the scar.

KELO-COTE® Gel has been shown to flatten, soften and smooth scars, relieve the itching, discomfort and pain of scars, as well as reduce the discolouration associated with scars.

Silicone gels have been shown to be effective in treating abnormal scarring in the form of hypertrophic scars and keloids. The 2014 International Clinical Recommendations on Scar Management supports the use of silicones as the preferred first line therapy for the treatment of linear hypertrophic scars, minor keloids and in the prevention of hypertrophic scars.*

Store: Below 25°C. Do not use after the expiration (EXP) date printed on the tube.

Ingredients: Cyclopentasiloxane, Dimethicone, Silica, Dimethicone Crosspolymer

Pack sizes: Box of 1 tube 6 gram, Box of 1 tube 15 gram.

Lot number and Expiry date are printed on the base of the carton.

Medical device owner:
Advanced Bio-Technologies, Inc. Address: West Kennedy Boulevard, Suite 600, Tampa,
Florida, 33609, USA
US Patent 5,741,509
Eur. Patent-Nr. 1439866, 1409034
*Gold MH et al. Dermatol Surg 2014;40: 825-831

Intended Use

KELO-COTE® Gel is for the treatment and prevention of hypertrophic and keloid scars resulting from burns, general surgical procedures and trauma wounds.

KELO-COTE® Gel is suitable for use on the face and body. KELO-COTE® Gel can be used on joints, flexures, hairy areas and large area scars such as those caused by burns or major trauma.

KELO-COTE® Gel is suitable for use on children over the age of 3 months and people with sensitive skin.

Direction for use

Ensure that the affected area is clean and dry. If using the 60g tube, remove cap and peel off foil before application. For the 6g and 15g tube, cut the tip of the nozzle with clean scissors before application. Apply KELO-COTE® Gel to the area using a clean finger twice daily as a very thin layer and allow to dry. For maximum effect, KELO-COTE® Gel should have 24 hour contact with the skin. Once dry, KELO-COTE® Gel can be covered with sun block or cosmetics. Replace cap after use.

If KELO-COTE® Gel has not dried within 4-5 minutes, you have probably used too much. Gently remove the excess and allow the drying process to continue.

Recommended minimum treatment time is 60-90 days. Larger and older scars may take longer and continued use is recommended if improvement is still seen after the initial 90 days.

Caution

For external use only. Do not use if you are hypersensitive to any of the ingredients in KELOCOTE® Gel. Avoid direct contact with eyes, mucous membranes, third degree burns and open wounds. KELO-COTE® Gel should not be used on dermatological conditions that disrupt the integrity of the skin. If irritation occurs, discontinue use and consult your physician.

KELO-COTE® Gel may stain clothing if it is not completely dry. Keep away from sources of ignition and do not smoke while applying the product or while the product is drying.

Keep out of the reach of children.