IMPORTANT SAFETY INFORMATION AND INDICATION

SURGISEAL is contraindica
ted on:

any wounds with evidence of microbial, bacterial, or fungal infections or gangrene

mucosal surfaces or across mucocutaneous junctions, or on skin which may be regularly exposed to body fluids or with dense natural hair

patients that have a hypersensitivity to cyanoacrylates or formaldehyde

Do not use SURGISEAL on wounds or skin surfaces that are wet, complex, non-acute, poorly perfused, or subject to repeated or prolonged moisture or friction, or in the presence of ongoing bleeding or incomplete debridement.

Do not use SURGISEAL below the skin, in decubitus ulcers, or in the eye. Avoid ingestion, internal application, and inadvertent contact with or intravascular injection of SURGISEAL.

Use of SURGISEAL may result in localized sensitization or irritation reactions. Large, unspread droplets of SURGISEAL may cause a sensation of heat or discomfort.

Instruct patients not to pick at SURGISEAL and not to scrub, soak, or otherwise expose the wound site to prolonged wetness.

Monitor and evaluate SURGISEAL treated wounds for signs of infection.

INDICATION

SURGISEAL is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma induced lacerations. SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.