SCARCARE GEL-PAD KIT by Blaine Labs Inc. SCARCARE GEL-PAD KIT-

SCARCARE GEL-PAD KIT by

Drug Labeling and Warnings

SCARCARE GEL-PAD KIT by is a Other medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INTENDED USE OF THE DEVICE

USES:
SCARCARE GEL-PAD KIT™ is intended for managing hypertrophic, hyperpigmented and keloid scar tissue.

CONTRAINDICATIONS

CONTRAINDICATIONS:
Do not apply to open wounds or third degreee burns. Never use on a sutured wound until sutures have been removed 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

Rashes may occur on skin under gel-pad due to poor or insufficient
hygiene. Rashes may also result from wrapping gel-pad too tightly
around skin. Should a rash or irritation of skin occur, stop use for a
minimum of 12 hours before next treatment. Stop use and ask a doctor
if rash persists.

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

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

INDICATIONS & USAGE

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

2) Cut the gel-pad to fit the scar area as needed, so that the edges extend at least 1/4” beyond the scar on all sides.

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 gel-pad 8-12 hours per treatment. Wait 8-12 hours without use before next treatment.

5) After removal of gel-pad, apply 1-2 drops of E-Sil™ onto the scar, massage gently until absorbed. Repeat as needed.

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 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.

* Proper use, and gentle care of the gel-pad will be re-usable up to eight (8) days.

PRECAUTIONS

PRECAUTIONS:
Do not apply to open wounds or third degree burns. Never use on a sutured wound until sutures have been removed or when any dermatological conditions disrupt the skin (such as a rash or burn). 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 gel-pad has been applied. Stop use and ask a doctor if product is applied properly and skin irritation still occurs. Persons with dermatological disorders should contact their doctor prior to using this product.

Product Label

BLAINELABS

NDC 63347- 150-01
MDA-K001608
US PATENT # 6,572,878

SCARCARE

GEL-PAD MATRIX

MEDICAL-GRADE SILICONE GEL MATRIX
WITH VITAMIN E

ONE (1) GEL-PAD - 3” x 5.5” (NON-STERILE)
ONE (1) E-SIL SOLUTION - 0.5 FL OZ (15 mL)

GUARANTEED TO FLATTEN AND FADE ANY SCAR
OF ANY AGE, OR YOUR MONEY BACK*!

MADE FROM THE FINEST MEDICAL-GRADE SILICONE MATRIX

EASY-TO-USE, COMFORTABLE TO WEAR
WITH VITAMIN E

WASHABLE AND REUSABLE

CUT TO FIT THE SHAPE AND SIZE OF ANY SCAR

CUSTOM SIZES ALSO AVAILABLE

*WHEN USED PROPERLY. PLEASE READ PRODUCT DIRECTIONS AND CONSULT A DOCTOR FOR APPROPRIATE USAGE.

 SCARCARE GEL-PAD KIT™ IS BACKED BY BLAINE LABS®’ 100 PERCENT, PATIENT-DIRECT,

MONEY-BACK GUARANTEE. CALL THE NUMBER BELOW FOR MORE INFORMATION.

QUESTIONS OR COMMENTS? CALL (800) 307-8818,

M-F, 8:00 AM-5:00 PM (PST)

MANUFACTURED BY:
BLAINE LABS, INC.
1 1 0 3 7 LOCKPORT PLACE
SANTA FE SPRINGS, CA 90670
BLAINELABS.COM

MADE IN THE U.S.A.

PLEASE RECYCLE! THIS
PACKAGE IS MADE FROM
RECYCLABLE MATERIALS.

04000-01-P-BOX
REV20190723

DISPENSED EXCLUSIVELY BY PHYSICIANS
NOT AUTHORIZED FOR INTERNET SALE

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Outer Box

Inner Foil

Insert

rege

INGREDIENTS AND APPEARANCE

SCARCARE GEL-PAD KIT 
elastomer, silicone, for scar management

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:63347-150

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:63347-150-01	1 in 1 BOX
1		1 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

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

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture