VIVERA SCARCARE PATCH WITH E-SCAR

Manufacturer
Vivera Pharmaceuticals, Inc. | Blaine Labs Inc.
Effective date
2019-03-01
Label type
MEDICAL DEVICE
Version
3
Source
full-release
Hydrated at
2026-06-01 02:49:14

Label at a glance#

ProductVIVERA SCARCARE PATCH WITH E-SCAR
Label structure8 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS: If irritation develops,

discontinue use and contact your physician.

PRECAUTIONS SECTION

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 SECTION

INGREDIENTS: Dimethylpolysiloxane,

Dimethiconol, Cyclopentasiloxane,

Cyclotetrasiloxane, Tocopheryl Acetate,

(Vitamin E)

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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_OutrTVIA ScarCare_Outr

res

PACKAGE LABEL.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_botleeScar_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-Pad TM ​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_DeviceScarCare_Device

res

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72380-183-03VIVERA SCARCARE PATCH WITH E-SCAR1 in 1 POUCHKIT13
72380-183-03VIVERA SCARCARE PATCH WITH E-SCAR2 in 1 BOXKIT23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72380-183VIVERA SCARCARE PATCH WITH E-SCAR () KIT [VIVERA PHARMACEUTICALS, INC.]32 package rows20190302_997af082-1948-46e2-8ce8-dbb2cdea8c1c.zip
72380-727VIVERA SCARCARE PATCH WITH E-SCAR () KIT [VIVERA PHARMACEUTICALS, INC.]3Unmatched20190302_997af082-1948-46e2-8ce8-dbb2cdea8c1c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72380-183-03EA - Each72380-18314987cbb-3501-4e14-9b33-c936cbcf3ec112018-12-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72380-18372380-183-03
72380-72772380-727-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsName fallback
generic name: DIMETHICONE
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsName fallback
generic name: DIMETHICONE
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsName fallback
generic name: DIMETHICONE
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsName fallback
generic name: DIMETHICONE
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsName fallback
generic name: DIMETHICONE
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsName fallback
generic name: DIMETHICONE
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsName fallback
generic name: DIMETHICONE
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsName fallback
generic name: DIMETHICONE
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsName fallback
generic name: DIMETHICONE
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsName fallback
generic name: DIMETHICONE
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsName fallback
generic name: DIMETHICONE
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsName fallback
generic name: DIMETHICONE
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsName fallback
generic name: DIMETHICONE
Neoteric Diabetic Skin Care 4 oz.DIMETHICONERNA PHARMA LLC536f4e79-201b-7100-e063-6394a90a4f822026-06-16WarningsName fallback
generic name: DIMETHICONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.