ZINGO

Absorption A single dose of ZINGO in adults did not produce detectable plasma concentrations of lidocaine (limit of quantitation 5 ng/mL) in any subject tested (n = 38). Application of ZINGO to broken or inflamed skin, or multiple ZINGO applications, could result in systemic plasma levels of lidocaine that could produce systemic toxicity.

DistributionWhen lidocaine is administered intravenously to healthy volunteers, the steady-state volume of distribution is approximately 0.8 to 1.3 L/kg. At m...

Efficacy in Adults The efficacy of ZINGO in adults was evaluated in a randomized, double-blind, parallel-arm, sham-placebo controlled trial in which adult patients who required a venipuncture or peripheral venous cannulation received either ZINGO or a sham placebo device. Patients were treated with ZINGO or a placebo device at the antecubital fossa or back of the hand, between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the procedure. Efficacy was measured using a continuous 100 mm visual analogue scale rang...

---------------------ADVERSE REACTIONS--------------------- The most common adverse reactions (>5%) are skin reactions at the site of administration: erythema, petechiae, edema, and pruritus (6.1) To report SUSPECTED ADVERSE REACTIONS, contact 7T Pharma, LLC, at 1-800-941-2848 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION. Revised: December 2025

---------------------CONTRAINDICATIONS--------------------- ZINGO is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type. (4)

---------------WARNINGS AND PRECAUTIONS--------------- Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. (5.1) Use on intact skin only (2.1, 5) Avoid contact with the eye (2.1, 5) Do not use if device is dropped or the pouch is damaged or torn (2.1) Patients with bleeding tendencies or platelet disorders could have a higher risk of superficial dermal bleeding (5)

7 DRUG INTERACTIONS Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine...