nbgs ScarSilk Medical Grade Silicone Scar Pad

Manufacturer
NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY
Effective date
2019-04-09
Label type
MEDICAL DEVICE
Version
4
Source
full-release
Hydrated at
2026-06-01 02:49:15

Label at a glance#

Productnbgs ScarSilk Medical Grade Silicone Scar Pad
Label structure12 sections

Indications and uses

For use in the management of closed hyperproliferative (hypertrophic or keloid) scars.

Dosage and administration

Wash hands and scar area thoroughly with soap and water. Completely dry the area after. If needed, cut the nbgs ScarSilk Pad to size making sure to leave at least 1/4” beyond the area of the scar. Peel off the backing of the sheet and place it sticky side down on the affected area. For best results, leave on for 8-12 hours per day. Each sheet lasts 7 days, box contains 1 month supply.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

nbgs ScarSilk Medical Grade Silicone Scar Pad
Rx only
For external use only
Not for ophthalmic use

nbgs ScarSilk Medical Grade Silicone Scar Pad Description

DESCRIPTION SECTION

nbgs ScarSilk Medical Grade Silicone Scar Pad is intended for use in the management of closed hyperproliferative scars, both old and new hypertrophic or keloid scars resulting from burns, surgical procedures or trauma wounds.

Each PAD contains: Medical Grade Silicone

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

The exact mechanism of action in improving the appearance of scar tissue from using silicone remains unknown. However, various suggestions have been made to explain the efficacy of silicone sheets, including hydration, pressure, temperature, oxygen transmission and silicone absorption. There is some evidence that the treatment affects the stratum corneum and, by reducing evaporation, restores better homeostasis in the tissue. In keloid and hypertrophic scarring, the stratum corneum allows more evaporation of water from the underlying tissue than occurs in normal skin. Silicone pads may prevent this, keeping the stratum corneum in optimal hydration and protecting the skin from environmental hazards, both of which can reduce abnormal scarring. The gel may also affect the stratum corneum by inhibiting mast cell activity, diminishing edema, vasodilatation and excessive extracellular matrix formation but the simple changes in temperature, pressure, oxygen tension and hydration produced by wound coverage probably constitute the main mechanism of action. Another hypothesis is that the effect of static electricity on silicone may influence the alignment of collagen deposition.

INDICATIONS AND USES

INDICATIONS & USAGE SECTION

For use in the management of closed hyperproliferative (hypertrophic or keloid) scars.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

nbgs ScarSilk Medical Grade Silicone Scar Pad is contraindicated in patients with known hypersensitivity to silicone or any of the listed ingredients.

WARNINGS

WARNINGS SECTION

For external use only. Avoid contact with eyes. Do not apply on areas of broken skin. Do not apply on third degree burns and open wounds. Never use on sutured wound until sutures have been removed.

PRECAUTIONS

PRECAUTIONS SECTION

Stop use and ask a doctor if irritation develops. In rare instances, silicone sheets may cause a rash on the skin. This condition may result from improper cleansing of the scar area where the silicone pad has been applied. If this product is applied properly and skin irritation still occurs, discontinue use and consult your physician. If ingested, get medical help or contact Poison Control Center right away.
KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

This medication should be used as directed by your physician during pregnancy or while breastfeeding. Consult your doctor about the risks and benefits.

CAUTION: Federal law restricts this device to sale by or on the order of a physician.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

On rare occasions, the Pads may cause temporary redness, stinging, burning or irritation and normally disappear when the medication is discontinued.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

  1. Wash hands and scar area thoroughly with soap and water. Completely dry the area after.
  2. If needed, cut the nbgs ScarSilk Pad to size making sure to leave at least 1/4” beyond the area of the scar.
  3. Peel off the backing of the sheet and place it sticky side down on the affected area.
  4. For best results, leave on for 8-12 hours per day.
  5. Each sheet lasts 7 days, box contains 1 month supply.

How is nbgs ScarSilk Medical Grade Silicone Scar Pad Supplied

HOW SUPPLIED SECTION

STORAGE AND HANDLING SECTION

nbgs ScarSilk Medical Grade Silicone Scar Pad (Silicone Gel Matrix) is supplied in:
4 Non-Sterile Silicone Gel Pads – 5 cm × 14 cm in 1 Carton

Store at 20°-25°C (68° to 77°F); Keep away from heat and protect from freezing. [See USP Controlled Room Temperature.]

SPL UNCLASSIFIED SECTION

Manufactured for:
NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72678-001-01nbgs ScarSilk Medical Grade Silicone Scar Pad4 in 1 CARTONPATCH44
72678-001-01nbgs ScarSilk Medical Grade Silicone Scar Pad1 in 1 POUCHPATCH14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72678-001NBGS SCARSILK MEDICAL GRADE SILICONE SCAR PAD (SILICONE MATRIX) PATCH [NATIONAL BIO GREEN SCIENCES LIMITED LIABILITY COMPANY]42 package rows20190410_2bcaebfb-7376-4fbf-981b-7ce423cc0b81.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72678-001-01EA - Each72678-00113d740a1-a650-4e61-adbf-a2bf65463c7112019-04-11

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72678-00172678-001-01

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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