KelaRx by Sterling-Knight Pharmaceuticals, LLC KELARX-

KelaRx by

Drug Labeling and Warnings

KelaRx by is a Other medication manufactured, distributed, or labeled by Sterling-Knight Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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