Lidocaine Hydrochloride Monohydrate

Generic Name: lidocaine hydrochloride monohydrate

Over-the-Counter (OTC)

Brand Names:

Zingo

11 DESCRIPTION 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.

Overview

11 DESCRIPTION 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.

Uses

------------------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)

Dosage

---------------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)

Side Effects

---------------------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

Interactions

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, 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, s...

Warnings

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

Storage

16 HOW SUPPLIED/STORAGE AND HANDLING NDC 61388-123 ZINGO ® (lidocaine hydrochloride monohydrate) powder intradermal injection system contains 0.5 mg of sterile lidocaine hydrochloride monohydrate. ZINGO ® is a single-dose device packaged in an individual clear pouch. Twelve pouched devices are placed in labeled cartons.

Frequently Asked Questions

What is Lidocaine Hydrochloride Monohydrate used for?

------------------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)

What are the side effects of Lidocaine Hydrochloride Monohydrate?

---------------------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

What are the important warnings for Lidocaine Hydrochloride Monohydrate?

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

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.