Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Trifluent Pharma LLC
RevivaSil™ Gel-Pad Kit is intended for managing hypertrophic, hyperpigmented, and keloid scar tissue.
Non-sterile product is labeled as such and supplied in protective packaging and container.
Exempt device
REVIVA-SIL- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT TRIFLUENT PHARMA LLC ---------- 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" Đọc toàn bộ tài liệu