CICASIL SILICONE GEL-PAD-

Drug Details [pdf]

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

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

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

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

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

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

res

INGREDIENTS AND APPEARANCE

CICASIL SILICONE GEL-PAD
elastomer, silicone, for scar management

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:63347-170

#	Item Code	Package Description
Packaging
1	NHRIC:63347-170-01	4 in 1 BOX
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
premarket notification	K001608	09/14/2017

Labeler - Blaine Labs Inc. (017314571)

Name	Address	ID/FEI	Business Operations
Establishment
Blaine Labs Inc.		017314571	manufacture

CICASIL SILICONE GEL-PAD-

CICASIL SILICONE GEL-PAD by

Drug Labeling and Warnings

Drug Details [pdf]