VIVERA SCARCARE PATCH WITH E-SCAR- elastomer, silicone, for scar management   
Vivera Pharmaceuticals, Inc.

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VIVERA SCARCARE PATCH WITH E-SCAR

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.

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: If irritation develops,

discontinue use and contact your physician.

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.

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

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

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

Revised: 3/2019
Document Id: 75913401-2267-4e10-8c46-a6b4ac2c4083
Set id: 997af082-1948-46e2-8ce8-dbb2cdea8c1c
Version: 3
Effective Time: 20190301
 
Vivera Pharmaceuticals, Inc.