SKARCADE GEL-PAD KIT-

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Available from:

PLUM VALLEY PHARMA LLC

Therapeutic indications:

INDICATIONS Gel Sheeting is intended for use in the management, control, and prevention of old and new hypertrophic or keloid scars resulting from burns or surgical or traumatic injury of the skin. CONTRAINDICATIONS Do not use on open wounds or when any Dermatological conditions disrupt the skin (such as a rash). INSTRUCTIONS FOR USE Silicone Gel Sheeting - Wash both scar and hands per cleaning instructions. - Open the non-sterile pouch containing the Silicone Gel Sheet. - Clear gel sheeting is covered on both sides by a plastic film. Fabric gel sheeting is covered on the tacky side by a plastic film. Remove plastic film prior to use. - The gel sheet may be cut into smaller pieces using scissors or a scalpel. Once you have determined the appropriate size of sheeting to use, apply tacky side to the scar. The gel sheeting should fully cover the scar and extend ¼ inch all the way around the scar border. - The exposed surface of the gel sheeting may be covered wi

Product summary:

HOW SUPPLIED Non-sterile product is labeled as such and supplied in a protective package within a protective outer container.

Authorization status:

Premarket Notification

Summary of Product characteristics

SKARCADE GEL-PAD KIT- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT
PLUM VALLEY PHARMA LLC
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SKARCADE GEL-PAD KIT
INDICATIONS
Gel Sheeting is intended for use in the management, control, and
prevention of old and
new hypertrophic or keloid scars resulting from burns or surgical or
traumatic injury of
the skin.
CONTRAINDICATIONS
Do not use on open wounds or when any Dermatological conditions
disrupt the skin
(such as a rash).
HOW SUPPLIED
Non-sterile product is labeled as such and supplied in a protective
package within a
protective outer container.
WARNINGS, PRECAUTIONS, ADVERSE REACTIONS
POSSIBLE COMPLICATIONS INCLUDE:
Superficial maceration
of the skin
Rash,
Skin Discoloration
Pruritus,
Sheeting tack and
thickness vary
Rashes have been observed on skin under the gel sheeting, this has
been attributed to
poor or insufficient hygiene. Similar rashes have been attributed to
gel sheeting being
wrapped too tightly. Should a rash occur, stop using the gel sheeting
for 12 hours
followed by using the gel sheeting for 12 hours. If the rash persists,
a physician should
be contacted, and gel sheeting use should be discontinued.
Discoloration of the skin covered by silicone gel sheeting has been
reported, particularly
in dark skinned patients. This effect appears to be transient and may
be similar to the
discoloration experienced whenever an area of skin is covered for
extended periods of
time.
Some patients report differences in gel sheeting surface tack and
thickness from sheet
to sheet. Perception of tack is subjective and the adhesive
characteristic of gel sheeting
may vary. These variations do not affect the function of the product.
Small bubbles may form after repeated washing and use. This does not
have an impact
on the function of the product.
Do not use creams, lotions, sun block or other silicone products on
your skin when
wearing silicone gel sheeting. These products will create a barrier
between the scar site
and silicone gel, preventing a proper healing environment.
For children under 5 years of age, use u