VISILAGE RX SILICONE GEL-PAD () [VIVERA PHARMACEUTICALS, INC.]

VISILAGE RX SILICONE GEL-PAD () [VIVERA PHARMACEUTICALS, INC.]
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NDC 72380-101-10
Set ID d8631cd0-a801-4c5b-a0f4-5e866b2a4d2a
Category MEDICAL DEVICE
Packager Vivera Pharmaceuticals, Inc.
Generic Name
Product Class
Product Number
Application Number K001608
  • SPL UNCLASSIFIED SECTION

    VISILAGE RX®
    SILICONE GEL-PAD

    BY PRESCRIPTION ONLY

  • INTENDED USE OF THE DEVICE

    USES:
    Visilage RX Silicone Gel-Pad® is intended for use in management and
    prevention of hypertrophic, keloid, and hyperpigmented scars from burns,
    surgeries, or traumatic injury of the skin.

  • CONTRAINDICATIONS

    CONTRAINDICATIONS:
    Do not use on open wounds, sutured wounds, or when any
    dermatological conditions disrupt the skin (such as a rash or burn).

  • HOW SUPPLIED

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

  • WARNINGS AND PRECAUTIONS

    WARNINGS, PRECAUTIONS, ADVERSE REACTIONS:
    Possible complications include:
    • Superficial maceration of the skin       • Skin discoloration
    • Sheeting tack and thickness vary        • Rash
    • Pruritus (itching skin)

    Rashes may occur on skin under gel sheet due to poor or insufficient
    hygiene. Rashes may also result from wrapping gel sheet too tightly
    around skin. Should a rash or irritation of skin occur, stop use for a
    minimum 12 hours or until irritation subsides. If rash persists, discontinue
    use and contact a physician.

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

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

    In case of consumption seek professional assistance or contact a
    Poison Control Center immediately at 1-800-222-1222.

  • INDICATIONS & USAGE

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

    2) Measure the Visilage Rx Silicone Gel-Pad® to fit the scar area so that the
    edges of the gel-pad extend at least 1/4” beyond the scar on all sides. Cut as
    needed.

    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 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 fingers
    to gently wash the gel-pad with anti-bacterial 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.

    * Gel-Pad will last eight (8) days with proper use and gentle care.

  • PRECAUTIONS

    PRECAUTIONS:
    Do not apply to an open wound or second/third degree burns. Never use on a sutured
    wound until sutures have been removed. 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 silicone pad has been applied. If this product is applied properly and
    skin irritation still occurs, discontinue use and consult your physician. Persons with
    dermatological disorders should contact their physician prior to using this product.

  • Principal Display Panel

    VIVERA®
    PHARMACEUTICALS

    VISILAGE RX®
    SILICONE GEL-PAD

    BY PRESCRIPTION ONLY

    VIVERA® ​                                                 
    PHARMACEUTICALS

    NDC# 72380-101-10

    VISILAGE RX®
    SILICONE GEL-PAD

    LOT NO.:
    EXPIRATION:

    MEDICAL-GRADE SILICONE GEL MATRIX
    US PATENT # 6,572,878
    15 DAY SUPPLY - TWO (2) GEL-PADS - 2” x 5.5” (NON-STERILE)

    6 16728 00067 5

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

    2) Measure the Visilage Rx Silicone Gel-Pad® to fit the scar area so that the
        edges of the gel-pad extend at least 1/4” beyond the scar on all sides. Cut as
        needed.

    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 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 fingers
        to gently wash the gel-pad with anti-bacterial 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.

    * Gel-Pad will last eight (8) days with proper use and gentle care.

    PRECAUTIONS:
    Do not apply to an open wound or third degree burn. Never use on a sutured
    wound until sutures have been removed. 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 silicone pad has been applied. If this
    product is applied properly and skin irritation still occurs, discontinue use and
    consult your physician. Persons with dermatological disorders should contact
    their physician prior to using this product.

    KEEP OUT OF THE REACH OF CHILDREN.
    FOR EXTERNAL USE ONLY.

    STORE AT 20°-25°C (68° TO 77°F); KEEP AWAY FROM HEAT AND PROTECT
    FROM FREEZING.

    VIVERA®
    PHARMACEUTICALS

    MANUFACTURED FOR:
    VIVERA PHARMACEUTICALS, INC.
    4533 MACARTHUR BLVD. #5049
    NEWPORT BEACH, CA 92660

    MADE IN USA

    THIS PACKAGE IS MADE FROM
    RECYCLABLE MATERIALS.

    US PATENT # 6,572,878
    04000-03-P-BOX
    REV20190114

    Visilage Box

    ↓Pouch Label↓

    Visilage Foil

    ↓Patient Insert↓

    Visilage PIP 1_2

    Visilage PIP2-2

    Visilage Rx® ​Silicone Gel-Pad by Vivera Pharmaceuticals, Inc.

    res

  • INGREDIENTS AND APPEARANCE
    VISILAGE RX SILICONE GEL-PAD 
    elastomer, silicone, for scar management
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:72380-101
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72380-101-102 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 notificationK00160812/01/2018
    Labeler - Vivera Pharmaceuticals, Inc. (081244342)
    Registrant - Vivera Pharmaceuticals, Inc. (081244342)

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