Histoacryl® and Histoacryl® Blue are sterile, liquid topical skin adhesives composed of n-Butyl-2-Cyanoacrylate monomer. The two products are different in only one respect: Histoacryl® is provided as a colorless liquid, and Histoacryl® Blue is colored with the dye D&C Violet #2 in order to make it easier to see the thickness of the layer of Histoacryl® Blue being applied. Histoacryl® and Histoacryl® Blue topical skin adhesives are supplied in a 0.5 ml single patient use plastic ampoules. Each ampoule is sealed within a foil pouch so the exterior of the ampoule can remain sterile. Histoacryl® remains liquid until exposed to acidic, basic, alcohol, water or watercontaining substances, including tissues. Histoacryl® cures (polymerizes exothermically) and forms a film that bonds to the underlying surface. All references to Histoacryl® herein refer to both Histoacryl® (without dye) and Histoacryl® Blue (with dye) unless stated otherwise.Histoacryl® and Histoacryl® Blue topical skin adhesives are intended for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl® and Histoacryl® Blue may be used in conjunction with, but not in place of, dermal sutures.Histoacryl® topical skin adhesive is not to be applied below the surface of the skin. The liquid adhesive will react exothermically with tissue; the polymerized adhesive is not absorbed by any tissues and may elicit a foreign body reaction.

• Histoacryl® is not to be applied to any internal organs, blood vessels, nerve tissue, mucosal surfaces or mucocutaneous junctions, areas with dense natural hair, or within the conjunctival sac of the eye.

• Histoacryl® is not to be applied to the surface of the eye. If the eyelids are accidentally bonded closed, release eyelashes with warm water by covering with a wet pad. The adhesive will bond to eye protein and will cause periods of weeping which will help to debond the adhesive. Keep the eye covered until debonding is complete – usually within 1 to 3 days. Do not force the eye open.

• Histoacryl® is not to be applied to wounds subject to high skin tension, or on areas of increased skin tension such as the elbows, knees, or knuckles. Histoacryl® is not to be used in areas of skin excision.

• Histoacryl® is not to be applied to wounds that show evidence of infection, gangrene or wounds of decubitus etiology.

• Histoacryl® is not to be used on patients with known preoperative systemic infections, uncontrolled diabetes, or diseases or conditions that are known to interfere with the wound healing process.

• Histoacryl® is not to be used on patients with a known hypersensitivity to cyanoacrylate, formaldehyde, or the dye D&C Violet