Label: CICASIL SILICONE GEL-PAD-

  • 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.

  • 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

    CICASIL Box

    CICASIL Foil

    CICASIL PiP

    res

  • INGREDIENTS AND APPEARANCE
    CICASIL SILICONE GEL-PAD 
    elastomer, silicone, for scar management
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:63347-170
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:63347-170-014 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK00160809/14/2017
    Labeler - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture