Label: LIDOCAINE- lidocaine hydrochloride injection, solution

  • NDC Code(s): 63323-201-03, 63323-201-10, 63323-202-01, 63323-202-02
  • Packager: Fresenius Kabi USA, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 11, 2024

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  • SPL UNCLASSIFIED SECTION
    Rx only - Local Anesthetic for Infiltration and Nerve Block - Not for Spinal or Epidural Anesthesia
  • DESCRIPTION
    Lidocaine Hydrochloride Injection, USP is a local anesthetic which is a sterile, nonpyrogenic solution intended for parenteral injection. See INDICATIONS AND USAGE for specific uses. Lidocaine ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - Lidocaine HCl stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic ...
  • INDICATIONS AND USAGE
    Lidocaine Hydrochloride Injection, USP is indicated for the production of local anesthesia, by infiltration techniques, such as percutaneous injection, and by peripheral nerve block techniques ...
  • CONTRAINDICATIONS
    Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
  • WARNINGS
    LIDOCAINE HYDROCHLORIDE INJECTION FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE ...
  • PRECAUTIONS
    General - The safety and effectiveness of lidocaine HCl depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Standard textbooks should be consulted for ...
  • ADVERSE REACTIONS
    To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Systemic - Adverse experiences following the ...
  • OVERDOSAGE
    Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local ...
  • DOSAGE AND ADMINISTRATION
    Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of lidocaine hydrochloride injection for various types of anesthetic procedures.  The dosages suggested in this ...
  • MAXIMUM RECOMMENDED DOSAGES
    NOTE: The products accompanying this insert do not contain epinephrine. Adults - For normal healthy adults, the individual maximum recommended dose of lidocaine hydrochloride without ...
  • HOW SUPPLIED
    Lidocaine Hydrochloride Injection is preserved with 0.1% methylparaben and is available in the following concentrations: Product - Code - Unit of ...
  • SPL UNCLASSIFIED SECTION
    www.fresenius-kabi.com/us - 45776F - Revised: June 2022
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine 10 mL Multiple Dose Vial Label - NDC 63323-201-03         20110 - LIDOCAINE HCl - INJECTION, USP - 1% 100 mg per - 10 mL (10 mg per mL) FOR ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine 10 mL Multiple Dose Tray Label - NDC 63323-201-10         20110 - LIDOCAINE HCl - INJECTION, USP - 1% 100 mg per 10 mL - (10 mg per mL) FOR ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine 2 mL Vial Label - NDC 63323-202-01         20202 - LIDOCAINE HCl - INJECTION, USP - 2% 40 mg per 2 mL - (20 mg per mL) FOR INFILTRATION AND NERVE ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY – Lidocaine 2 mL Tray Label - NDC 63323-202-02          20202 - LIDOCAINE HCl - INJECTION, USP - 2% 40 mg per 2 mL - (20 mg per mL) FOR INFILTRATION - AND NERVE ...
  • INGREDIENTS AND APPEARANCE
    Product Information