Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Lidocaine 3% Cream is supplied as a white cream in: 1 oz. (28.35 g) tubes, NDC 13925-159-01 3 oz. (85 g) tubes, NDC 13925-159-03; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC-13925-159-01 Net Wt. 1 oz. (28.35 g) Lidocaine 3% Cream Topical Anesthetic FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. SETON PHARMACEUTICALS Lidocaine 3% - Hydrocortisone 0.5% Cream
- HOW SUPPLIED: Lidocaine 3% Cream is supplied as a white cream in: 1 oz. (28.35 g) tubes, NDC 13925-159-01 3 oz. (85 g) tubes, NDC 13925-159-03
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Rx Only NDC-13925-159-01 Net Wt. 1 oz. (28.35 g) Lidocaine 3% Cream Topical Anesthetic FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. SETON PHARMACEUTICALS Lidocaine 3% - Hydrocortisone 0.5% Cream
Overview
Lidocaine 3% Cream is a topical anesthetic indicated for the relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness, and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes.
Indications & Usage
INDICATIONS: Anesthetic for relief of pruritus, pruritic eczemas, abrasions, minor burns, insect bites, pain, soreness and discomfort due to pruritus ani, pruritus vulvae, hemorrhoids, anal fissures, and similar conditions of the skin and mucous membranes.
Dosage & Administration
: Apply a thin film to the affected area two or three times daily or as directed by a physician.
Warnings & Precautions
WARNINGS: For external use only. Not for ophthalmic use. 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 and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and 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 [the use of this product] and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.
Contraindications
: Traumatized mucosa, secondary bacterial infection of the area of proposed application and known hypersensitivity to any of the components. Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.
Adverse Reactions
During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation. Call your doctor about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Drug Interactions
Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antieoplastic agents cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics dapsone, sulfonamides, nitrofurantoin, para-aminosalicyclic acid Antimalarials chloroquine, primaquine Anticonvulsants phenytoin, sodium valproate, phenobarbital Other drugs acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine
Storage & Handling
STORAGE AND HANDLING SECTION KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on the therapeutic equivalence. Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86º F). See USP Controlled Room Temperature. Protect from freezing. Marketed by: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 Iss. 01/19 1900008 seton logo
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.