SILTREX SILICONE GEL-PAD-

SILTREX SILICONE GEL-PAD by

Drug Labeling and Warnings

SILTREX 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

SILTREX®
SILICONE GEL-PAD

BY PRESCRIPTION ONLY

DESCRIPTION

USES:
Siltrex Silicone Gel-Pad® is intended for use in the management, control, and prevention of old and new hypertrophic or keloid scars resulting from burns or surgical or traumatic injury of the skin.

HOW SUPPLIED:
Non-sterile product is labeled as such and supplied in a protective package within a protective outer container.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

WARNINGS, PRECAUTIONS, ADVERSE REACTIONS:
Possible complications include:

Superficial maceration of the skin Skin discoloration
Sheeting tack and thickness vary Rash
Pruritus

Rashes have been observed on skin under the gel sheeting, this has
been attributed to poor or insufficient hygiene. Similar rashes have been
attributed to gel sheeting being wrapped too tightly. Should a rash
or irritation of the skin occur, stop use of the gel sheeting for at least
12 hours or until the rash or irritation completely subsides. If the rash
persists, a physician should be contacted, and gel sheeting use should be
discontinued.

Discoloration of the skin covered by silicone gel sheeting has been
reported, particularly in dark skinned patients. This effect appears to be
transient and may be similar to the discoloration experienced whenever
an area of skin is covered for extended periods of time.

Perception of tack is subjective, and the adhesive characteristic of the
Siltrex Silicone Gel-Pad® may vary. These variations do not affect the function of
the product.

Small bubbles may form after repeated use and washing. This does not
have an impact on the function of the product.

Do not use creams, lotions, sun block or other silicone products on your
skin when wearing silicone gel sheeting. These products will create a
barrier between the scar site and silicone gel preventing a proper healing
environment.

SPL UNCLASSIFIED SECTION

KEEP OUT OF THE REACH OF CHILDREN.
FOR EXTERNAL USE ONLY.

DOSAGE & ADMINISTRATION

DIRECTIONS FOR USE:

1) Wash your hands and the scar area with soap and water. Dry thoroughly.

2) Measure the Siltrex 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 finger 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 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 conditions should
contact their physician prior to using this product.

Principal Display Panel

VIVERA®
PHARMACEUTICALS

SILTREX®
SILICONE GEL-PAD

BY PRESCRIPTION ONLY

VIVERA® NDC# 72380-183-03
PHARMACEUTICALS

SILTREX®
SILICONE GEL-PAD

BY PRESCRIPTION ONLY

LOT NO.

SEE INDIVIDUAL COMPONENTS FOR EXP DATE

MEDICAL-GRADE SILICONE GEL MATRIX
(PATENTED TECHNOLOGY & FORMULA)
15 DAY SUPPLY - TWO (2) GEL-PADS - 2” x 5.5” (NON-STERILE)

DIRECTIONS FOR USE:
1) Wash your hands and the scar area with soap and water. Dry thoroughly.
2) Measure the SILTREX 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 finger 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
11100 GREENSTONE AVE.
SANTA FE SPRINGS, CA 90670

MADE IN USA

THIS PACKAGE IS MADE FROM RECYCLABLE MATERIALS.

04000-02-P-BOX
REV20180925

Product Label - Foil Pack

Zipper

DURABLE REUSABLE WASHABLE RESEALABLE PACKAGE! DURABLE REUSABLE WASHABLE

VIVERA® NDC# 72380-183-03
PHARMACEUTICALS

SILTREX®
SILICONE GEL-PAD

A safe and effective method for managing
hypertrophic, hyperpigmented and keloid scar tissue.

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

04000-01-P-FOIL
REV20180926

MANUFACTURED FOR: VIVERA PHARMACEUTICALS 11100 GREENSTONE AVE. SANTA FE SPRINGS, CA 90670
STORE AT 20°-25°C (68° TO 77°F); KEEP AWAY FROM HEAT AND PROTECT FROM FREEZING.

UNPRINTED

LOT# EXP DATE STAMPED

Product Label - Patient Insert

INGREDIENTS AND APPEARANCE

SILTREX SILICONE GEL-PAD 
elastomer, silicone, for scar management

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K001608	10/01/2018

Labeler - Vivera Pharmaceuticals, Inc. (081244342)

Registrant - Vivera Pharmaceuticals, Inc. (081244342)