SIL-BRX PAD LARGE-

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Доступно од:

Blaine Labs Inc.

Терапеутске индикације:

USES: Sil-BRX Silicone Gel-Pad Matrix is intended for use in management and prevention of hypertrophic, keloid, and hyperpigmented scars from burns, surgeries, or traumatic injury of the skin. CONTRAINDICATIONS: Do not use on open wounds, sutured wounds, or when any dermatological conditions disrupt the skin (such as a rash or burn).

Резиме производа:

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

Статус ауторизације:

Premarket Notification

Карактеристике производа

SIL-BRX PAD LARGE- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT
BLAINE LABS INC.
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SIL-B PAD
SIL-B PAD
SILICONE GEL-PAD MATRIX
USES:
Sil-BRX Silicone Gel-Pad Matrix is intended for use in management and
prevention of hypertrophic, keloid, and hyperpigmented scars from
burns,
surgeries, or traumatic injury of the skin.
CONTRAINDICATIONS:
Do not use on open wounds, sutured wounds, or when any
dermatological conditions disrupt the skin (such as a rash or burn).
HOW SUPPLIED:
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
• Pruritus
Rashes may occur on skin under gel sheet due to poor or insufficient
hygiene. Rashes may also result from wrapping gel sheet too tightly
around skin. Should a rash or irritation of skin occur, stop use for a
minimum 12 hours or until irritation subsides. If rash persists,
discontinue
use and contact a physician.
Discoloration of skin covered by gel sheeting may temporarily occur in
patients with darker complexions.
Do not use creams, lotions, sun block, or other silicone products on
your
skin when wearing silicone gel sheeting. Only apply gel sheeting to
clean,
bare skin.
DIRECTIONS FOR USE:
1) Wash your hands and the scar area with soap and water. Dry
thoroughly.
2) Measure the SIL-B PAD to fit the scar area, so that the edges of the gelpad
extend at least 1/4” beyond the scar on all sides. Cut as needed.
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 treatment. Wait 8-12 hours without use
before
next treatment.
5) When not wearing the gel-pad, place the gel-pad (sticky side) back
onto the
mylar release strip. Place