Label: VIVERA SCARCARE PATCH WITH E-SCAR- kit

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated March 1, 2019

If you are a consumer or patient please visit this version.

  • INDICATIONS & USAGE

    DIRECTIONS FOR USE:

    1) Wash hands and the scar area with soap and water. Dry thoroughly.

    2) Cut the ScarCare Gel-PadTM to fit the scar area, as needed, so that the edges

    of the gel-pad extend at least 1/4" beyond the edge of the scar on all sides.

    3) Gently peel the gel-matrix 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 teatment. Wait 8-12 hours without use before next

    treatment.

    5) Rub 1-2 drops of E-Scar Solution onto the scar when not wearing the gel-pad.

    6) 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.

    7) When the sticky side of the gel-pad appears dirty or worn, use your finger to

    gently wash the gel-pad with antibacterial soapand 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 seven (7) days with proper use and gentle care.

  • SPL UNCLASSIFIED SECTION

    DIRECTIONS: Clean the area with soap

    and water. Let dry. Apply 1-2 drops onto the

    scar when not wearing the gel-pad. Massage

    gently until absorbed.

  • WARNINGS

    WARNINGS: If irritation develops,

    discontinue use and contact your physician.

  • PRECAUTIONS

    PRECAUTIONS:

    Do not apply to open wound or third degree burn. Never use on

    a sutured wound until the 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 has been 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.

  • OTHER SAFETY INFORMATION

    KEEP OUT OF REACH OF CHILDREN.

    FOR EXTERNAl USE ONLY.

  • INACTIVE INGREDIENT

    INGREDIENTS: Dimethylpolysiloxane,

    Dimethiconol, Cyclopentasiloxane,

    Cyclotetrasiloxane, Tocopheryl Acetate,

    (Vitamin E)

  • Principal Display Package

    VIVERA

    PHARMACEUTICALS

    SCARCARE

    GEL-PAK KIT

    BY PRESCRIPTION ONLY

    VIVERA NDC #72380-727-01

    PHARMACEUTICALS MDA K001608

    LOT NO.

    SEE INDIVIDUAL COMPONENTS FOR EXP DATE

    MEDICAL-GRADE SILICONE GEL MATRIX

    (PATENTED FORMULA)

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

    ONE (1) E-SCAR THERAPY SOLUTION - 15 mL (0.5 FL OZ)

    DIRECTIONS FOR USE:

    1) Wash hands and the scar area with soap and water. Dry thoroughly.

    2) Cut the ScarCare Gel-PadTM to fit the scar area, as needed, so that the edges

    of the gel-pad extend at least 1/4" beyond the edge of the scar on all sides.

    3) Gently peel the gel-matrix 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 teatment. Wait 8-12 hours without use before next

    treatment.

    5) Rub 1-2 drops of E-Scar Solution onto the scar when not wearing the gel-pad.

    6) 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.

    7) When the sticky side of the gel-pad appears dirty or worn, use your finger to

    gently wash the gel-pad with antibacterial soapand 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 seven (7) days with proper use and gentle care.

    PRECAUTIONS:

    Do not apply to open wound or third degree burn. Never use on

    a sutured wound until the 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 has been 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 REACH OF CHILDREN.

    FOR EXTERNAl USE ONLY.

    STORE AT 20O-25O C (68O TO 77O F) KEEP AWAY FRO HEAT AND PROTECT FROM FREEZING

    VIVERA

    PHARMACEUTICALS

    MANUFACTURED FOR:

    VIVERA PHARMACEUTICALS

    11100 GREENSTONE AVE.

    SANTA FE SPRINGS, CA 90670

    04000-01-P-BOX

    REV 20180706

    TVIA ScarCare_Outr

    res

  • PRINCIPAL DISPLAY PANEL

    VIVERA NDC# 72380-727-01

    PHARMACEUTICALS

    E-SCAR

    SCAR THERAPY

    SOLUTION

    15 mL (0.5 FL OZ)

    INGREDIENTS: Dimethylpolysiloxane,

    Dimethiconol, Cyclopentasiloxane,

    Cyclotetrasiloxane, Tocopheryl Acetate,

    (Vitamin E)

    WARNINGS: ​If irritation develops,

    discontinue use and contact your physician.

    DIRECTIONS: Clean the area with soap

    and water. Let dry. Apply 1-2 drops onto the

    scar when not wearing the gel-pad. Massage

    gently until absorbed.

    Manufactured for:

    Vivera Pharmaceuticals

    11100 Greenstone Ave. 04000-01-PL-LBL

    Santa Fe Springs, CA 90670 REV20180629

    eScar_botle

    ZIPPER

    DURABLE ● REUSABLE ● WASHABLE RESEALABLE PACKAGE! DURABLE ● REUSABLE ● WASHABLE

    VIVERA NDC# 72380-727-01

    PHARMACEUTICALS MDA-K001608

    SCARCARE

    GEL-PAD KIT

    A safe and effective method for managing

    hypertrophic, hyperpigmented and keloid scar tissue.

    DIRECTIONS FOR USE:

    1) Wash hands and the scar area with soap and water. Dry thoroughly.

    2) Cut the ScarCare Gel-PadTM ​to fit the scar area, as needed, so that the edges

    of the gel-pad extend at least 1/4" beyond the edge of the scar on all sides.

    3) Gently peel the gel-matrix 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 teatment. Wait 8-12 hours without use before next

    treatment.

    5) Rub 1-2 drops of E-Scar Solution onto the scar when not wearing the gel-pad.

    6) 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.

    7) When the sticky side of the gel-pad appears dirty or worn, use your finger to

    gently wash the gel-pad with antibacterial soapand 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 seven (7) days with proper use and gentle care.

    PRECAUTIONS:

    Do not apply to open wound or third degree burn. Never use on

    a sutured wound until the 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 has been 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.

    MANUFACTURED FOR VIVERA PHARMACEUTICALS, 11100 GREENSTONE AVE., SANTA FE SPRINGS, CA 90670

    STORE AT 20O-25O C (68O TO 77O F) KEEP AWAY FRO HEAT AND PROTECT FROM FREEZING

    KEEP OUT OF REACH OF CHILDREN.

    FOR EXTERNAL USE ONLY.

    04000-01-P-FOL

    REV20180706

    UNPRINTED

    LOT # EXP DATE STAMPED

    ScarCare_Device

    res

  • INGREDIENTS AND APPEARANCE
    VIVERA SCARCARE PATCH WITH E-SCAR 
    elastomer, silicone, for scar management kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:72380-183
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72380-183-032 in 1 BOX
    11 in 1 POUCH; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    E-SCAR 
    dimethylpolysiloxane, dimethiconol,cyclopentasiloxane, cyclotetrasiloxane, tocopheryl acetate solution/ drops
    Product Information
    Item Code (Source)NDC:72380-727
    Route of AdministrationTOPICAL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) 3 mL  in 15 mL
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW) 3 mg  in 15 mL
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 3 mg  in 15 mL
    CYCLOMETHICONE 4 (UNII: CZ227117JE) 3 mg  in 15 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 3 mg  in 15 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72380-727-011 in 1 PACKAGE
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK00160807/01/2018
    Labeler - Vivera Pharmaceuticals, Inc. (081244342)
    Registrant - Blaine Labs Inc. (017314571)
    Establishment
    NameAddressID/FEIBusiness Operations
    Blaine Labs Inc.017314571manufacture