Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
PLUM VALLEY PHARMA LLC
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
HOW SUPPLIED Non-sterile product is labeled as such and supplied in a protective package within a protective outer container.
Premarket Notification
SKARCADE GEL-PAD KIT- ELASTOMER, SILICONE, FOR SCAR MANAGEMENT PLUM VALLEY PHARMA LLC ---------- 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 Přečtěte si celý dokument