-
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
- WARNINGS
-
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
- INACTIVE INGREDIENT
-
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
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
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
res
-
INGREDIENTS AND APPEARANCE
VIVERA SCARCARE PATCH WITH E-SCAR
elastomer, silicone, for scar management kitProduct Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:72380-183 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:72380-183-03 2 in 1 BOX 1 1 in 1 POUCH; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 15 mL Part 1 of 1 E-SCAR
dimethylpolysiloxane, dimethiconol,cyclopentasiloxane, cyclotetrasiloxane, tocopheryl acetate solution/ dropsProduct Information Item Code (Source) NDC:72380-727 Route of Administration TOPICAL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:72380-727-01 1 in 1 PACKAGE 1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K001608 07/01/2018 Labeler - Vivera Pharmaceuticals, Inc. (081244342) Registrant - Blaine Labs Inc. (017314571) Establishment Name Address ID/FEI Business Operations Blaine Labs Inc. 017314571 manufacture