ZINGO

ZINGO ® (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile lidocaine hydrochloride monohydrate. The chemical name is 2-diethylamino-2',6'-acetoxylidide, monohydrochloride, monohydrate. The molecular formula is C 14 H 22 N 2 O · HCl · H 2 O with a molecular weight of 288.8 Da. Lidocaine hydrochloride monohydrate, a local anesthetic of the amide class, has the following structural formula: Lidocaine hydrochloride monohydrate is freely soluble in water, soluble in alcohol and chloroform, insoluble in ether, and melts at around 74–79°C. ZINGO is a ready-to-use, sterile, single-use, disposable, needle-free delivery system. ZINGO consists of the following components: a drug reservoir cassette filled with 0.5 mg lidocaine hydrochloride monohydrate as a powder with a nominal particle size of 40 µm, a pressurized helium gas cylinder, and a safety interlock. The safety interlock prevents inadvertent actuation of the device. Once ZINGO is pressed against the skin, the interlock is released, allowing the button to be depressed to actuate the device. A sound similar to that of a popping balloon is emitted at the time ZINGO is actuated. structure formula

------------------INDICATIONS AND USAGE------------------- 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. (1) ZINGO is indicated for use on intact skin to provide topical local analgesia prior to venipuncture in adults. (1) Important Limitations : For use on intact skin only (1, 2) For external use only (5) 1 INDICATIONS AND USAGE ZINGO is indicated for use on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation, in children 3–18 years of age. ZINGO is indicated for use on intact skin to provide topical local analgesia prior to venipuncture in adults.

---------------DOSAGE AND 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. (2.1) Perform the procedure within 10 minutes after ZINGO administration. (2) Use ZINGO only on intact skin. (2) 2 DOSAGE AND 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. Application of one additional ZINGO at a new location is acceptable after a failed attempt at venous access. Multiple administrations of ZINGO at the same location are not recommended. When ZINGO is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all sources should be considered, as local anesthetics are thought to have at least additive toxicities. 2.1 Instructions for Use 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 (Figure 1a). Remove ZINGO from the pouch, being careful not to touch the purple outlet (open end) to avoid contamination (Figure 1b). Position ZINGO : Grip ZINGO and place on the application site, with one hand, as illustrated in Figure 2, or with both hands, as shown in Figure 3. 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, like the one illustrated in Figure 4, 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, as illustrated in Figure 5a. ZINGO cannot be actuated without releasing the internal safety interlock, as illustrated in Figure 5b. Administer ZINGO : While maintaining downward pressure, administer the dose by pressing the green start button, as illustrated in Figure 6. 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. Figure 1a Figure 1b Figure Figure 3 Figure 4 Figure 5a Figure 5b Figure 6

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

---------------------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 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of ZINGO has been evaluated in 10 clinical trials, five in adults and five in pediatric patients. The five adult clinical trials consisted of a randomized, double-blind, parallel-arm, sham-placebo controlled Phase 3 trial that enrolled 693 patients, two randomized, double-blind, crossover design, sham-placebo controlled Phase 1 trials that enrolled 455 patients, and two open-label studies that enrolled 44 patients. A total of 742 adults received an active treatment with an active treatment that delivered a 0.5 mg dose of lidocaine, while 775 received placebo. The five pediatric clinical trials consisted of five randomized, double-blind, parallel-arm, sham-placebo controlled trials in which 1761 patients, ages 3 to 18, received either ZINGO or a sham placebo device. A total of 906 pediatric patients received active treatment, while 855 received placebo. Application Site Reaction The application site was specifically assessed for four categories of skin site reaction (erythema, edema, pruritus, and petechiae). In adults, erythema occurred in 67.3% of ZINGO-treated patients, and in 25.0% of placebo-treated patients. Petechiae occurred in 46.4% of ZINGO-treated patients, and in 7.0% of placebo-treated patients. Edema occurred in 4.3% of ZINGOtreated patients, and in 0.8% of placebo-treated patients. Pruritus occurred in 9.4% of ZINGO-treated patients and in 6.2% of placebo-treated patients. In pediatric patients, erythema occurred in 53% of ZINGO-treated patients, and in 27% of placebo-treated patients. Petechiae occurred in 44% of ZINGO-treated patients, and in 5% of placebo-treated patients. Edema occurred in 8% of ZINGO-treated patients, and in 3% of placebo-treated patients. Pruritus occurred in 1% of patients in both treatment groups. Adverse Reactions Amongst the 742 adult patients receiving active treatment and 775 adult patients receiving sham placebo treatment in the 5 adult studies, the percentage of adult patients with any adverse reactions was 3.9% in the active-treated patients and 4.9% in the sham placebo treated patients. Most adverse reactions were application-site related (i.e., hypoaesthesia (0% active, 0.5% sham placebo), burning (0.54% active, 0.4% sham placebo), and venipuncture site hemorrhage (0.4% active, 1.7% sham placebo)). The most common systemic adverse reaction was dizziness, which occurred in 0.9% of active-treated adult patients and in 0.7% of sham placebo treated adult patients. No other systemic adverse events occurred in more than two patients in either treatment group. Amongst the 906 pediatric patients receiving active treatment and 855 pediatric patients receiving sham placebo treatment, the percentage of pediatric patients with any adverse reactions was approximately 9% in each treatment group. Most adverse reactions were application-site related (i.e., bruising, burning, pain, contusion, hemorrhage), occurring in 4% of pediatric patients in each treatment group. The most common systemic adverse reactions were nausea (2%) and vomiting (1%).

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, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate, Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine