VISILAGE RX SILICONE GEL-PAD-

VISILAGE RX SILICONE GEL-PAD by

Drug Labeling and Warnings

VISILAGE RX SILICONE GEL-PAD by is a Other medication manufactured, distributed, or labeled by Vivera Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

VISILAGE RX®
SILICONE GEL-PAD

BY PRESCRIPTION ONLY

INTENDED USE OF THE DEVICE

USES:
Visilage RX Silicone Gel-Pad® is intended for use in management and
prevention of hypertrophic, keloid, and hyperpigmented scars from burns,
surgeries, or traumatic injury of the skin.

CONTRAINDICATIONS

CONTRAINDICATIONS:
Do not use on open wounds, sutured wounds, or when any
dermatological conditions disrupt the skin (such as a rash or burn).

HOW SUPPLIED

HOW SUPPLIED:
Non-sterile product is labeled as such and supplied in protective
packaging and container.

WARNINGS AND PRECAUTIONS

WARNINGS, PRECAUTIONS, ADVERSE REACTIONS:
Possible complications include:
Superficial maceration of the skin       Skin discoloration
Sheeting tack and thickness vary        Rash
Pruritus (itching skin)

Rashes may occur on skin under gel sheet due to poor or insufficient
hygiene. Rashes may also result from wrapping gel sheet too tightly
around skin. Should a rash or irritation of skin occur, stop use for a
minimum 12 hours or until irritation subsides. If rash persists, discontinue
use and contact a physician.

Discoloration of skin covered by gel sheeting may temporarily occur in
patients with darker complexions.

Do not use creams, lotions, sun block, or other silicone products on your
skin when wearing silicone gel sheeting. Only apply gel sheeting to clean,
bare skin.

In case of consumption seek professional assistance or contact a
Poison Control Center immediately at 1-800-222-1222.

INDICATIONS & USAGE

DIRECTIONS FOR USE:
1) Wash your hands and the scar area with soap and water. Dry thoroughly.

2) Measure the Visilage Rx Silicone Gel-Pad® to fit the scar area so that the
edges of the gel-pad extend at least 1/4” beyond the scar on all sides. Cut as
needed.

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

5) 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.

6) When the sticky side of the gel-pad appears dirty or worn, use your fingers
to gently wash the gel-pad with anti-bacterial soap and 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 eight (8) days with proper use and gentle care.

PRECAUTIONS

PRECAUTIONS:
Do not apply to an open wound or second/third degree burns. Never use on a sutured
wound until 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 is 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.

Principal Display Panel

VIVERA®
PHARMACEUTICALS

VISILAGE RX®
SILICONE GEL-PAD

BY PRESCRIPTION ONLY

VIVERA® ​                                                 
PHARMACEUTICALS

NDC# 72380-101-10

VISILAGE RX®
SILICONE GEL-PAD

LOT NO.:
EXPIRATION:

MEDICAL-GRADE SILICONE GEL MATRIX
US PATENT # 6,572,878
15 DAY SUPPLY - TWO (2) GEL-PADS - 2” x 5.5” (NON-STERILE)

6 16728 00067 5

​DIRECTIONS FOR USE:
1) Wash your hands and the scar area with soap and water. Dry thoroughly.

2) Measure the Visilage Rx Silicone Gel-Pad® to fit the scar area so that the
    edges of the gel-pad extend at least 1/4” beyond the scar on all sides. Cut as
    needed.

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

5) 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.

6) When the sticky side of the gel-pad appears dirty or worn, use your fingers
    to gently wash the gel-pad with anti-bacterial soap and 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 eight (8) days with proper use and gentle care.

PRECAUTIONS:
Do not apply to an open wound or third degree burn. Never use on a sutured
wound until 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 is 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 THE REACH OF CHILDREN.
FOR EXTERNAL USE ONLY.

STORE AT 20°-25°C (68° TO 77°F); KEEP AWAY FROM HEAT AND PROTECT
FROM FREEZING.

VIVERA®
PHARMACEUTICALS

MANUFACTURED FOR:
VIVERA PHARMACEUTICALS, INC.
4533 MACARTHUR BLVD. #5049
NEWPORT BEACH, CA 92660

MADE IN USA

THIS PACKAGE IS MADE FROM
RECYCLABLE MATERIALS.

US PATENT # 6,572,878
04000-03-P-BOX
REV20190114

↓Pouch Label↓

↓Patient Insert↓

Visilage Rx® ​Silicone Gel-Pad by Vivera Pharmaceuticals, Inc.

res

INGREDIENTS AND APPEARANCE

VISILAGE RX SILICONE GEL-PAD 
elastomer, silicone, for scar management

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:72380-101

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:72380-101-10	2 in 1 BOX
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K001608	12/01/2018

Labeler - Vivera Pharmaceuticals, Inc. (081244342)

Registrant - Vivera Pharmaceuticals, Inc. (081244342)