VIVERA SCARCARE PATCH WITH E-SCAR- kit

VIVERA SCARCARE PATCH WITH E-SCAR by

Drug Labeling and Warnings

VIVERA SCARCARE PATCH WITH E-SCAR by is a Other medication manufactured, distributed, or labeled by Vivera Pharmaceuticals, Inc., Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 kit

Product 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/ drops

Product 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