REVIVA-SIL- silicone gel pad kit

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Dostopno od:

Trifluent Pharma LLC

Terapevtske indikacije:

RevivaSil™ Gel-Pad Kit is intended for managing hypertrophic, hyperpigmented, and keloid scar tissue.

Povzetek izdelek:

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

Status dovoljenje:

Exempt device

Lastnosti izdelka

REVIVA-SIL- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT
TRIFLUENT PHARMA LLC
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REVIVASIL™ GEL- PAD KIT
USES
RevivaSil™ Gel-Pad Kit is intended for managing hypertrophic,
hyperpigmented, and
keloid scar tissue.
HOW SUPPLIED
Non-sterile product is labeled as such and supplied in protective
packaging and
container.
POSSIBLE REACTIONS INCLUDE
Superficial maceration of the skin
Skin discoloration
Pruritus
Rash
Rashes may occur on skin under gel-pad due to poor hygiene. Rashes may
also result
from wrapping gel-pad too tightly around skin. Stop use and ask a
doctor if gel-pad is
applied properly and skin irritation still occurs.
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.
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.
DIRECTIONS FOR USE
1)
2)
3)
4)
5)
6)
7)
* Proper use, and gentle care of the gel-pad will be re-usable up to
eight (8) days.
PRODUCT FACTS
ACTIVE
COMPONENT
PURPOSE
Patented Silicone
Gel Matrix Pad
Skin Scar
Treatment
COMPONENTS
Silicone Gel Matrix Pad (3'' X 5.5'')
Engineered as a self-adhesive pad; there is no need for additional
wraps or taping. The
non-sticky side is smooth and soft to prevent fabrics from adhering.
DIRECTIONS
1)
Wash your hands and the scar area with soap and water. Dry thoroughly.
Cut the RevivaSil™ Gel-Pad to fit the scar area as needed, so that
the edges extend
at least 1/4"