国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Blaine Labs Inc.
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.
Premarket Notification
SIL-BRX PAD LARGE- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT BLAINE LABS INC. ---------- 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 阅读完整的文件