CICASIL SILICONE GEL-PAD

Manufacturer
Blaine Labs Inc.
Effective date
2020-01-28
Label type
MEDICAL DEVICE
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:28

Label at a glance#

ProductCICASIL SILICONE GEL-PAD
Label structure7 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

PRESCRIPTION ONLY

INTENDED USE OF THE DEVICE

USES:
CICASIL™ SILICONE GEL-PAD is intended for managing hypertrophic, hyperpigmented and keloid scar tissue.

HOW SUPPLIED SECTION

HOW SUPPLIED:
Non-sterile product is labeled as such and supplied in protective packaging and container.

ADVERSE REACTIONS SECTION

POSSIBLE REACTIONS INCLUDE:
• Superficial maceration of the skin • Skin discoloration
• Pruritus • Rash
Rashes may occur on skin under gel-pad due to poor hygiene. Rashes may also result from wrapping gel-pad too tightly around skin. Stop use and ask a doctor if gel-pad is applied properly and skin irritation still occurs.

Discoloration of skin covered by gel-pad may temporarily occur in patients with darker complexions.

Do not use creams, lotions, sun block, or other silicone products on your skin when wearing gel-pad. Only apply gel-pad to clean, bare skin.

PRECAUTIONS SECTION


PRECAUTIONS:
Do not apply to open wounds or third degree burns. Never use on a sutured wound until sutures have been removed or when any dermatological conditions disrupt the skin (such as a rash or burn). 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 gel-pad has been applied. Stop use and ask a doctor if product is applied properly and skin irritation still occurs. Persons with dermatological disorders should contact their doctor prior to using this product.

INSTRUCTIONS FOR USE SECTION

DIRECTIONS FOR USE:
1) Wash your hands and the scar area with soap and water. Dry thoroughly.

2) Cut the Gel-Pad to fit the scar area as needed, so that the edges extend at
least 1/4” beyond the scar on all sides.

3) Gently peel the gel-pad from the mylar release strip (it is normal for small
bits of the gel to remain on the mylar release strip). Do not discard the mylar
release strip.

4) Place the sticky side of the gel-pad directly onto the scar. For best results,
wear the gel-pad 8-12 hours per treatment. Wait 8-12 hours without use
before next treatment.

5) When not wearing the gel-pad, place the gel-pad (sticky side) back onto
the mylar release strip. Place the gel-pad back into the original pouch for protection.

6) When the sticky side of the gel-pad appears dirty or worn, use your finger
to gently wash the gel-pad with soap and water, as needed. Rinse with water
and allow to air dry. The stickiness will return once dry. Do not fold while
washing or drying.

* Proper use, and gentle care of the gel-pad will be re-usable up to eight (8) days.

Product Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESCRIPTION ONLY

BLAINE LABS

NDC 63347- 170-01
MDA-K001608
US PATENT # 6,572,878

CICASILTM
S I L I CONE GEL-PAD

MEDICAL-GRADE SILICONE GEL MATRIX
FOUR (4) GEL-PADS - 2” x 5.5” (NON-STERILE)

RX ONLY

BLAINE LABS

CICASILTM
S I L I CONE GEL-PAD

RX ONLY

MADE FROM THE FINEST MEDICAL-GRADE SILICONE MATRIX
EASY-TO-USE, COMFORTABLE TO WEAR
WASHABLE AND REUSABLE
CICASIL™ SILICONE GEL-PAD IS ABLE TO BE CUT AS NEEDED

QUESTIONS OR COMMENTS? 800.307.8818 M-F, 8:00 AM-5:00 PM (PST)

MANUFACTURED BY:
BLAINE LABS, INC.
1 1 0 3 7 LOCKPORT PLACE
SANTA FE SPRINGS, CA 90670
BLAINELABS.COM

PLEASE RECYCLE! THIS
PACKAGE IS MADE FROM
RECYCLABLE MATERIALS.

04200-01-P-BOX

REV20191121

LOT NO

CICASIL BoxCICASIL Box

CICASIL FoilCICASIL Foil

CICASIL PiPCICASIL PiP

res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63347-170-01CICASIL SILICONE GEL-PAD1 in 1 POUCH12
63347-170-01CICASIL SILICONE GEL-PAD4 in 1 BOX42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63347-170CICASIL SILICONE GEL-PAD () [BLAINE LABS INC.]22 package rows20200129_4b50a3ac-9a23-41e8-b93c-a68fb94bdd87.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63347-170-01EA - Each63347-170e0d010d3-6eb3-493a-a4c2-763c2e83a4c012020-05-08

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63347-17063347-170-01

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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