Label: LIDOCAINE patch
- NDC Code(s): 76420-887-30
- Packager: Asclemed USA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0603-1880
- 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 SECTIONR - xonly
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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 ...
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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 ...
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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 ...
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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.
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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.
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCEProduct Information