Derma+Flex® is a sterile high viscosity topical skin adhesive, formulated to facilitate easy application. It is provided in a 0.7 g single use aluminium collapsible tube and applicator packaged in a rigid PETG blister with a Tyvek® lid. The applicator is comprised of a self-puncturing cap and a soft, angled tip. When applied to the skin, Derma+Flex® gel adhesive sets quickly without burning or stinging the patient. The syrup-like viscosity makes the adhesive easy to apply and helps prevent it running from or into the wound. Derma+Flex® topical skin adhesive forms a flexible, waterproof microbial barrier over easily approximated wound edges to facilitate wound healing. The tube can be used for one or several indicated wounds on the same patient.

Derma+Flex® topical skin adhesive is for use by medical professionals to close surgical incisions and minor traumatic wounds with easily opposable skin edges in areas of low skin tension. It may be used in conjunction with, but not in place of, deep dermal sutures. In vitro studies have shown Derma+Flex® acts as a barrier to microbial penetration as long as the  adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

• Derma+Flex® topical skin adhesive should not be used internally, on or near the mucosa, on wounds of a decubitus etiology, on animal or human bites, or on infected wounds.
• Care should be taken to avoid contact with the eyes.
• Derma+Flex® topical skin adhesive should not be placed into incisions or lacerations and should not be used as a primary wound closure method in areas of high skin tension or in areas prone to movement,
  such as over joints.
• Derma+Flex® may be used in areas of dense natural hair as long as such areas are properly prepared and care is taken to prevent trapping hair in the wound.
• Derma+Flex® should not be used on wound sites that will be subjected to repeated or prolonged moisture or friction.
• It should not be used on patients with known allergies to cyanoacrylate or formaldehyde, or on patients with preoperative systemic infections, uncontrolled diabetes, or other diseases or conditions known to interfere with wound healing.
• Localised sensitization may occur.
• Excessive pressure of the applicator tip against wound edges or surrounding skin can force the wound edges apart and allow adhesive into the wound. Adhesive within the wound could delay wound healing and/or result in adverse cosmetic outcome.
• Do not place Derma+Flex® topical skin adhesive in a procedure pack/tray that is to be sterilized prior to use. Exposure of Derma+Flex® topical skin adhesive, after its final manufacture, to excessive heat (as in autoclaves) or radiation (such as gamma or electron beam), is known to increase its viscosity and may render the product unstable.
• Potential systemic toxicity of this product is unknown.
• The product is for single patient use only. Multiple use of the device on different patients increases the possibility of transfer of infection agents.

• Do not apply liquid or ointment medications or other substances to the wound after closure with Derma+Flex® High Viscosity Tissue Adhesive, as these substances can weaken the polymerized film and allow for wound dehiscence. Derma+Flex® High Viscosity Tissue Adhesive permeability by topical medications has not been studied.
• Derma+Flex® High Viscosity Tissue Adhesive permeability by fluids is not known and has not been studied.
• Derma+Flex® High Viscosity Tissue Adhesive, as a liquid, is syrup-like in viscosity. To prevent inadvertent flow of liquid Derma+Flex® High Viscosity Tissue Adhesive to unintended areas the patient should be positioned so that inadvertent flow would be away from unwanted areas.
• Hold applicator upward and away from yourself and the patient and squeeze the contents of the tube from the bottom of the tube towards the applicator.
• Derma+Flex® High Viscosity Tissue Adhesive should be used within 30 minutes after attaching the self-puncture applicator on the tube to avoid premature polymerization. The adhesive may be used as long as it remains in liquid form and has not been allowed to become contaminated.
• If unintended bonding of intact skin occurs, peel, but do not pull the skin apart. Petroleum jelly may help loosen the bond. Other agents such as water, saline, Betadine® Antibiotics, HIBICLENS® (chlorhexidene gluconate), or soap, are not expected to immediately loosen the bond.
• Safety and effectiveness of Derma+Flex® High Viscosity Tissue Adhesive on wounds of patients with peripheral vascular disease, insulin dependent diabetes mellitus, blood clotting disorders, personal or family history of keloid formation or hypertrophy, or burst stellate lacerations, have not been studied.
• Safety and effectiveness of Derma+Flex® High Viscosity Tissue Adhesive on the following wounds has not been studied: animal or human bites; puncture or stab wounds.
• Safety and effectiveness on wounds that have been treated with Derma+Flex® High Viscosity Tissue Adhesive and then exposed for prolonged periods to direct sunlight or tanning lamps have not been studied.
• Safety and effectiveness of Derma+Flex® High Viscosity Tissue Adhesive on wounds in vermilion surfaces has not been studied.

• Reactions may occur in patients who are hypersensitive to cyanoacrylate or formaldehyde.
• Adverse reactions may be experienced following Derma+Flex® High Viscosity Tissue Adhesive contact with the eye.