KelaRx Scar Care Gel

Manufacturer
Sterling-Knight Pharmaceuticals, LLC
Effective date
2018-09-21
Label type
MEDICAL DEVICE
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:07

Label at a glance#

ProductKelaRx
Label structure9 sections

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

KelaRx™

Scar Care Gel

Prescription Only

KelaRx Scar Care Gel Description

DESCRIPTION SECTION

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 

INDICATIONS & USAGE SECTION

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

Made in USA
Rev 0518-1

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image1image1

image2image2
Sterling-Knight Pharmaceuticals, LLC

Ripley, MS 38663
Made in USA
Rev 0518-1

KelaRx™

Scar Care Gel

Prescription Only

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130369336803304GTIN-13: 0369336803304
EAN-13: 0369336803304
GTIN-12: 369336803304
UPC-A: 369336803304
GTIN storage (14 digits): 00369336803304
kelalab2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69336-803-30KelaRx1 in 1 TUBE12
69336-803-30KelaRx1 in 1 CARTON12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69336-803KELARX () [STERLING-KNIGHT PHARMACEUTICALS, LLC]22 package rows20180921_5561e6bf-b315-48ba-b86c-bba130bbe544.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69336-803-30GM - Gram69336-8035780b6f7-9711-41d9-80ad-7a58efc73ead12018-08-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69336-80369336-803-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 128 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsName fallback
generic name: DIMETHICONE
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsName fallback
generic name: DIMETHICONE
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsName fallback
generic name: DIMETHICONE
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsName fallback
generic name: DIMETHICONE
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsName fallback
generic name: DIMETHICONE
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsName fallback
generic name: DIMETHICONE
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsName fallback
generic name: DIMETHICONE
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsName fallback
generic name: DIMETHICONE
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsName fallback
generic name: DIMETHICONE
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsName fallback
generic name: DIMETHICONE
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsName fallback
generic name: DIMETHICONE
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsName fallback
generic name: DIMETHICONE
Neoteric Diabetic Skin Care 4 oz.DIMETHICONERNA PHARMA LLC536f4e79-201b-7100-e063-6394a90a4f822026-06-16WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsName fallback
generic name: DIMETHICONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.