Ensure that the affected area is clean and dry. Apply KelaRx™to the area as a very thin coat and allow to dry. Apply KelaRx™ twice daily. Once dry, KelaRx™ can be covered with cosmetics or sunscreen. Recommended duration of treatment 60-90 days.
•Relieves itching, discomfort and pain associated with scars
•Helps prevent excessive and abnormal scar formation
•For use as mono-therapy or in combination with other scar therapies, including pressure garments.
KelaRx™ is a self-drying, flexible, gas permeable, waterproof silicone gel that is colorless and odorless. KelaRx™ forms a bond with the stratum corneum (the outer layer of dead skin cells) forming a protective barrier against chemical physical and microbial invasion of the scar site while assisting with hydration.
KelaRx™ is also for use on children or people with sensitive skin. Silicone Gel Sheets are internationally recommended as the first line of treatment in scar management.
KelaRx™ is intended for the management of old and new scars, including hypertrophic and keloid scars, resulting from general surgical procedures, trauma, wounds and burns.
WARNINGS
WARNINGS SECTION
Avoid direct contact with eyes, mucous membranes, third degree burns and open wounds. KelaRx™ should not be used on dermatological conditions that disrupt the integrity of the skin. For external use only. If irritation occurs, discontinue use and consult your physician. Keep this product out of the reach of children. Store below 25°C/77°F.
PRECAUTIONS
PRECAUTIONS SECTION
Caution:
Federal law restricts this device to sale by or on the order by a licensed healthcare practitioner.
CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
Ensure that the affected area is clean and dry. Apply KelaRx™to the area as a very thin coat and allow to dry. Apply KelaRx™ twice daily. Once dry, KelaRx™ can be covered with cosmetics or sunscreen. Recommended duration of treatment 60-90 days.
HOW SUPPLIED
HOW SUPPLIED SECTION
KelaRx™ Scar Care Gel is supplied as a white gel in: 30 g tube, NDC 69336-803-30
SPL UNCLASSIFIED SECTION
Distributed By:
Sterling-Knight Pharmaceuticals, LLC Ripley, MS 38663
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