Precautions, Cautions & Adverse Reactions

Precautions

  • Do not apply liquid or ointment medications or other substances to the wound after closure with derma+flex® Tissue Adhesive, as these substances can weaken the polymerized film and allow for wound dehiscence.
  • derma+flex® Tissue Adhesive permeability by topical medications has not been studied.
  • derma+flex® Tissue Adhesive permeability by fluids is not known and has not been studied.
  • derma+flex® Tissue Adhesive, as a liquid, is Gel like in viscosity. To prevent inadvertent flow of liquid derma+flex® 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® 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 or acetone 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® 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® 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® Tissue Adhesive and then exposed for prolonged periods to direct sunlight or tanning lamps have not been studied.
  • Safety and effectiveness of derma+flex® Tissue Adhesive on wounds in vermilion surfaces has not been studied.

Cautions

This product is meant for external dermal application only and should not contact the eyes.
This product should not be ingested, applied internally, or injected intravascularly.

Adverse Reactions

  • Reactions may occur in patients who are hypersensitive to cyanoacrylate or formaldehyde. See CONTRAINDICATIONS.
  • Adverse reactions may be experienced following derma+flex® Tissue Adhesive contact with the eye.

Betadine® Trademark of Purdue Fredericks †Registered Trademark of Zeneca Pharmaceuticals

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