Label: LIDOCAINE patch

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated December 25, 2024

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  • SPL UNCLASSIFIED SECTION
    R - xonly
  • DESCRIPTION
    LIDOCAINE PATCH 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a non‑woven polyester felt backing and covered with a polyethylene terephthalate (PET) film ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics - Lidocaine is an amide-type local anesthetic agent and is suggested to stabilize neuronal membranes by inhibiting the ionic fluxes required for the initiation and conduction ...
  • CLINICAL STUDIES
    Single-dose treatment with LIDOCAINE PATCH 5% was compared to treatment with vehicle patch (without lidocaine), and to no treatment (observation only) in a double‑blind, crossover clinical trial ...
  • INDICATION AND USAGE
    LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia.  It should be applied only to - intact skin.
  • CONTRAINDICATIONS
    LIDOCAINE PATCH 5% is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.
  • WARNINGS
    Risk of Methemoglobinemia - Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with ...
  • PRECAUTIONS
    General - Hepatic Disease - Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of lidocaine, because of their inability to metabolize ...
  • ADVERSE REACTIONS
    Application Site Reactions - During or immediately after treatment with LIDOCAINE PATCH 5%, the skin at the site of application may develop blisters, bruising, burning sensation ...
  • OVERDOSAGE
    Lidocaine overdose from cutaneous absorption is rare, but could occur. If there is any suspicion of lidocaine overdose (see - ADVERSE REACTIONS, Systemic Reactions), drug blood concentration ...
  • DOSAGE AND ADMINISTRATION
    Apply LIDOCAINE PATCH 5% to intact skin to cover the most painful area. Apply the prescribed number of patches (maximum of 3), only once for up to 12 hours within a 24 hour period.  Patches may be ...
  • HANDLING AND DISPOSAL
    Hands should be washed after the handling of LIDOCAINE PATCH 5%, and eye contact with LIDOCAINE PATCH 5% should be avoided.  Do not store patch outside the sealed envelope. Apply immediately after ...
  • HOW SUPPLIED
    LIDOCAINE PATCH 5% is available as the following: Carton of 30 patches, packaged into individual child-resistant envelopes - NDC 76420-887-30 (relabeled from NDC 0603-1880-16) Store at 25 - oC ...
  • PRINCIPAL DISPLAY PANEL
    LABEL
  • INGREDIENTS AND APPEARANCE
    Product Information