SIL-NESIC SILICONE GEL-PAD-

SIL-NESIC SILICONE GEL-PAD by

Drug Labeling and Warnings

SIL-NESIC SILICONE GEL-PAD by is a Other medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INTENDED USE OF THE DEVICE

USES:
sil-nesic 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.

The gel-pad is effective as long as it retains its stickiness. After several applications the
gel-pad may appear worn out but if it sticks to the skin it will keep working. Proper use and
gentle care of the gel-pad will be re-usable up to eight (8) days.

Product Packaging

US PATENT # 6,572,878

BLAINE LABS

SIL-NESIC

SCAR TREATMENT

MEDICAL GRADE SILICONE MATRIX

FOUR (4) GEL-PADS - 2" X 5.5" (NON-STERILE)

Box

Pouch

res

INGREDIENTS AND APPEARANCE

SIL-NESIC SILICONE GEL-PAD 
elastomer, silicone, for scar management

Product Information
Product Type	OTC MEDICAL DEVICE	Item Code (Source)	NHRIC:63347-160

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:63347-160-01	4 in 1 BOX
1		1 in 1 POUCH; Type 0: Not a Combination Product

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

Labeler - Blaine Labs Inc. (017314571)