Label: KELARX-

  • NHRIC Code(s): 69336-803-30
  • Packager: Sterling-Knight Pharmaceuticals, LLC
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated September 21, 2018

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  • SPL UNCLASSIFIED SECTION

    KelaRx™

    Scar Care Gel

    Prescription Only

  • 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 

    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

    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

    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

    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

    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

    Made in USA
    Rev 0518-1

  • PRINCIPAL DISPLAY PANEL

    image1

    image2
    Sterling-Knight Pharmaceuticals, LLC

    Ripley, MS 38663
    Made in USA
    Rev 0518-1

    KelaRx™

    Scar Care Gel

    Prescription Only

  • INGREDIENTS AND APPEARANCE
    KELARX 
    elastomer, silicone, for scar management
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:69336-803
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69336-803-301 in 1 CARTON
    11 in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK08371806/29/2018
    Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sterling-Knight Pharmaceuticals, LLC079556942manufacture
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