SIL-BRX PAD LARGE-

United States - English - NLM (National Library of Medicine)

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Available from:
Blaine Labs Inc.
Therapeutic indications:
USES: Sil-BRX Silicone Gel-Pad Matrix is intended for use in management and prevention of hypertrophic, keloid, and hyperpigmented scars from burns, surgeries, or traumatic injury of the skin. CONTRAINDICATIONS: Do not use on open wounds, sutured wounds, or when any dermatological conditions disrupt the skin (such as a rash or burn).
Product summary:
HOW SUPPLIED: Non-sterile product is labeled as such and supplied in protective packaging and container.
Authorization status:
Premarket Notification
Authorization number:
63347-615-01

SIL-BRX PAD LARGE- elastomer, silicone, for scar management

Blaine Labs Inc.

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SIL-B

PAD

SIL-B

PAD

Silicone Gel-Pad Matrix

USES:

Sil-BRX Silicone Gel-Pad Matrix is intended for use in management and

prevention of hypertrophic, keloid, and hyperpigmented scars from burns,

surgeries, or traumatic injury of the skin.

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:

Non-sterile product is labeled as such and supplied in protective

packaging and container.

WARNINGS, PRECAUTIONS, ADVERSE REACTIONS:

Possible complications include:

Superficial maceration of the skin Skin discoloration

Sheeting tack and thickness vary Rash

Pruritus

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.

DIRECTIONS FOR USE:

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

2) Measure the SIL-B

PAD to fit the scar area, so that the edges of the gelpad

extend at least 1/4” beyond the scar on all sides. Cut as needed.

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 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

RX

RX

RX

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 seven (7) days with proper use and gentle care.

KEEP OUT OF REACH OF CHILDREN.

FOR EXTERNAL USE ONLY.

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

FREEZING.

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.

Package Labeling

RX ONLY

BLAINE LABS

NDC# 63347-160-01

MDA-K001608

US PATENT # 6,572,878

SIL-B

PAD

(LARGE)

BY PRESCRIPTION ONLY

BLAINE LABS

SIL-B

PAD

(LARGE)

LOT NO.

MEDICAL-GRADE SILICONE GEL MATRIX

PATENTED FORMULA

FOUR (4) GEL-PADS - 2” x 5.5” (NON-STERILE)

RX ONLY

BLAINE LABS

MANUFACTURED BY:

BLAINE LABS, INC.

11037 LOCKPORT PLACE

SANTA FE SPRINGS, CA 90670

MADE IN THE USA

THIS PACKAGE IS MADE FROM

RECYCLABLE MATERIALS.

®

RX

®

RX

®

07000-500-BX

REV201900913

SIL-BRX PAD LARGE

elastomer, silicone, for scar management

Product Information

Product T ype

MEDICAL DEVICE

Ite m Code (Source )

NHRIC:6 3347-6 15

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NHRIC:6 3347-6 15-0 1

4 in 1 BOX

1

1 in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

premarket no tificatio n

K0 0 16 0 8

0 9 /14/20 17

Labeler -

Blaine Labs Inc. (017314571)

Registrant -

Blaine Labs Inc. (017314571)

Blaine Labs Inc.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Blaine Labs Inc.

0 17314571

ma nufa c ture

Revised: 9/2019

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