Label: CICASIL SILICONE GEL-PAD-
- NHRIC Code(s): 63347-170-01
- Packager: Blaine Labs Inc.
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated January 28, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- INTENDED USE OF THE DEVICE
- HOW SUPPLIED
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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.
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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.
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Product Package
PRESCRIPTION ONLY
BLAINE LABS
NDC 63347- 170-01
MDA-K001608
US PATENT # 6,572,878CICASILTM
S I L I CONE GEL-PADMEDICAL-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-PADRX 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 NEEDEDQUESTIONS 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.COMPLEASE RECYCLE! THIS
PACKAGE IS MADE FROM
RECYCLABLE MATERIALS.04200-01-P-BOX
REV20191121
LOT NO
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INGREDIENTS AND APPEARANCE
CICASIL SILICONE GEL-PAD
elastomer, silicone, for scar managementProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:63347-170 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:63347-170-01 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) Establishment Name Address ID/FEI Business Operations Blaine Labs Inc. 017314571 manufacture