SCARCARE GEL-PAD KIT- elastomer, silicone, for scar management
Blaine Labs Inc.
SCARCARE GEL-PAD KIT™ is intended for managing hypertrophic, hyperpigmented and keloid scar tissue.
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).
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
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.
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.
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.
NDC 63347- 150-01
US PATENT # 6,572,878
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)
BLAINE LABS, INC.
1 1 0 3 7 LOCKPORT PLACE
SANTA FE SPRINGS, CA 90670
MADE IN THE U.S.A.
PLEASE RECYCLE! THIS
PACKAGE IS MADE FROM
DISPENSED EXCLUSIVELY BY PHYSICIANS
NOT AUTHORIZED FOR INTERNET SALE
|SCARCARE GEL-PAD KIT
elastomer, silicone, for scar management
|Labeler - Blaine Labs Inc. (017314571)|
|Registrant - Blaine Labs Inc. (017314571)|
|Blaine Labs Inc.||017314571||manufacture|