- SPL UNCLASSIFIED SECTION
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KelaRx Scar Care Gel Description
For Old and New Scars
•Reduces redness
•Softens and flattens raised scars
•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.
Ingredients:
Dimethicone, Dimethicone Crosspolymer, Trimethylsiloxysilicate.
- INDICATIONS
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WARNINGS
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
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KELARX
elastomer, silicone, for scar managementProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:69336-803 Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:69336-803-30 1 in 1 CARTON 1 1 in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K083718 06/29/2018 Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942) Establishment Name Address ID/FEI Business Operations Sterling-Knight Pharmaceuticals, LLC 079556942 manufacture