Zingo is an amide local anesthetic indicated for use on intact skin to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children 3-18 years of age.

Important Limitations:

• For use on intact skin only
• For external use only

• Use on intact skin only
• Avoid contact with the eye
• Do not use if device is dropped or the pouch is damaged or torn
• Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding

Zingo Adverse Reactions

The most common adverse reactions (>5%) are skin reactions at the site of administration: erythema, petechiae, edema.

To report Suspected Adverse Reactions, contact Anesiva, Inc. at 1-650-624-9600 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Prepare the Treatment Site and Device: Examine the treatment site to ensure that the skin is intact. Clean the site, according to standard practice. Visually inspect the pouch. Do not use if the pouch has been torn, or damaged or if the device has been dropped. Tear open the pouch using the notch provided. Remove Zingo from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination.
• Position Zingo: Grip Zingo and place on the application site, with one hand, or with both hands. Ensure that the patient's treatment site is supported to prevent movement. Seal the purple Zingo outlet against the patient's skin. Hold the device perpendicular to the skin, making sure that your thumb can reach the green start button. Avoid gaps between the skin and the Zingo outlet as gaps will impede drug delivery.
• Release the Safety Interlock: Apply adequate downward pressure to release the safety interlock, while maintaining the seal between Zingo and the skin. Zingo is ready for administration when the green start button has moved into the upward position. Zingo cannot be actuated without releasing the internal safety interlock.
• Administer Zingo: While maintaining downward pressure, administer the dose by pressing the green start button. Do not move Zingo during administration. Actuation is accompanied by a "popping" sound, indicating that the dose has been discharged.
• Remove Zingo: Remove Zingo from the application site and dispose.
• Begin Procedure: Start the venipuncture or intravenous cannulation procedure 1-3 minutes after Zingo administration.

• Apply one Zingo (0.5 mg lidocaine hydrochloride monohydrate) to the site planned for venipuncture or intravenous cannulation, one to three minutes prior to needle insertion.
• Perform the procedure within 10 minutes after Zingo administration.
• Use Zingo only on intact skin.

Dosage Forms and Strengths

Zingo is a sterile, single-use, powder intradermal injection system containing 0.5 mg lidocaine hydrochloride monohydrate.

Zingo utilizes a helium-powered delivery system.