LIDOCAINE 5% 5 g/100g
lidocaine · CREAM · Medhome Pharma Inc
LIDOCAINE 5% is a cream containing lidocaine at 5 g/100g, taken topical. Manufactured by Medhome Pharma Inc.
Key Facts
- Brand Name
- LIDOCAINE 5%
- Generic Name
- lidocaine
- NDC Code (Product)
84007-335- Manufacturer
- Medhome Pharma Inc
- Strength
- 5 g/100g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- M017
- Drug Class
- Amide Local Anesthetic [EPC]; Antiarrhythmic [EPC]
- Marketing Start
- 12/23/2025
Recall History
Clinical Specialties Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
Dosage & Administration
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 cut into smaller sizes with scissors prior to removal of the release liner (see HANDLING AND DISPOSAL). Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. If irritation or a burning sensation occurs during application, remove the patch(es) and do not reapply until the irritation subsides. When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Lidocaine patch 5% may not stick if it gets wet. Avoid contact with water, such as bathing, swimming, or showering.
Warnings
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 glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine patch 5% and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen the…
Contraindications
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.
Drug Interactions
Drug Interactions Antiarrhythmic Drugs Lidocaine patch 5% should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic. Local Anesthetics When lidocaine patch 5% is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered. Drugs That May Cause Methemoglobinemia When Used with Lidocaine Patch 5% 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…
Adverse Reactions
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, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Allergic Reactions Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur. They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. Other Adverse Events Due to the nature and limitation of spontaneous reports in postmarketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresth…
Frequently Asked Questions
What is LIDOCAINE 5% used for?
LIDOCAINE 5% contains lidocaine. It is a cream taken topical. Consult your doctor for specific uses.
Is LIDOCAINE 5% a controlled substance?
LIDOCAINE 5% is not classified as a controlled substance by the DEA.
What is the generic name for LIDOCAINE 5%?
The generic name for LIDOCAINE 5% is lidocaine. There are 12 other brand versions of lidocaine.
What is the NDC code for LIDOCAINE 5% 5 g/100g?
The NDC (National Drug Code) for LIDOCAINE 5% 5 g/100g is 84007-335, listed by Medhome Pharma Inc.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)