VIVERA SCARCARE PATCH WITH E-SCAR- kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Available from:

Vivera Pharmaceuticals, Inc.

Therapeutic indications:

DIRECTIONS FOR USE: 1) Wash hands and the scar area with soap and water. Dry thoroughly. 2) Cut the ScarCare Gel-PadTM to fit the scar area, as needed, so that the edges of the gel-pad extend at least 1/4" beyond the edge of the scar on all sides. 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 teatment. Wait 8-12 hours without use before next treatment. 5) Rub 1-2 drops of E-Scar Solution onto the scar when not wearing the gel-pad. 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 antibacterial soapand water, as needed. Rinse with water and allow to a

Authorization status:

Premarket Notification

Summary of Product characteristics

VIVERA SCARCARE PATCH WITH E-SCAR- ELASTOMER, SILICONE, FOR SCAR
MANAGEMENT
VIVERA PHARMACEUTICALS, INC.
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VIVERA SCARCARE PATCH WITH E-SCAR
DIRECTIONS FOR USE:
1) Wash hands and the scar area with soap and water. Dry thoroughly.
2) Cut the ScarCare Gel-PadTM to fit the scar area, as needed, so that
the edges
of the gel-pad extend at least 1/4" beyond the edge of the scar on all
sides.
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 teatment. Wait 8-12 hours without use
before next
treatment.
5) Rub 1-2 drops of E-Scar Solution onto the scar when not wearing the
gel-pad.
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 antibacterial soapand 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.
DIRECTIONS: Clean the area with soap
and water. Let dry. Apply 1-2 drops onto the
scar when not wearing the gel-pad. Massage
gently until absorbed.
WARNINGS: If irritation develops,
discontinue use and contact your physician.
PRECAUTIONS:
Do not apply to open wound or third degree burn. Never use on
a sutured wound until the 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 has been applied properly and skin
irritation
still occurs, discontinue use and consult your physician. Persons with
dermatological disorders should contact their physician prior to