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NDC 35781-0301-05 Lidodose 3 mg/100mL Details
Lidodose 3 mg/100mL
Lidodose is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Gensco Laboratories, LLC. The primary component is LIDOCAINE HYDROCHLORIDE.
Product Information
NDC | 35781-0301 |
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Product ID | 35781-0301_ea3b2c15-c1c6-c4ea-e053-2995a90a1dae |
Associated GPIs | 90850060104015 |
GCN Sequence Number | 078558 |
GCN Sequence Number Description | lidocaine HCl MED. SWAB 3 % TOPICAL |
HIC3 | Q5H |
HIC3 Description | TOPICAL LOCAL ANESTHETICS |
GCN | 44907 |
HICL Sequence Number | 001478 |
HICL Sequence Number Description | LIDOCAINE HCL |
Brand/Generic | Brand |
Proprietary Name | Lidodose |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | LIDOCAINE HYDROCHLORIDE |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | TOPICAL |
Active Ingredient Strength | 3 |
Active Ingredient Units | mg/100mL |
Substance Name | LIDOCAINE HYDROCHLORIDE |
Labeler Name | Gensco Laboratories, LLC |
Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part348 |
Listing Certified Through | 2023-12-31 |
Package
Package Images



NDC 35781-0301-05 (35781030105)
NDC Package Code | 35781-0301-5 |
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Billing NDC | 35781030105 |
Package | 25 POUCH in 1 BOX (35781-0301-5) / 1 mL in 1 POUCH (35781-0301-0) |
Marketing Start Date | 2018-01-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0b3e8433-4f93-4f01-9df0-020fb6922bce Details
Dosage and Administration
Warning: for external use only.
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 LidoDose 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.
Avoid contact with eyes.
Stop use and consult a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use in large quantities, particularly over raw surfaces or blistered areas.
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, inepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine |
Antineoplastic agents | cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea |
Antibiotics | dapsone, sulfonamides, nitrofurantoin, para¬aminosalicylic acid |
Antimalarials | chloroquine, primaquine |
Anticonvulsants | phenytoin, sodium valproate, phenobarbital |
Other drugs | acetaminophen, metoclopramide, sulfa drugs (i.e., sulfasalazine), quinine |
Keep out of reach of children
Storage
PATIENT COUNSELING INFORMATION
Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.
Inactive Ingredients:
INGREDIENTS AND APPEARANCE
LIDODOSE
lidocaine hydrochloride gel |
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Labeler - Gensco Laboratories, LLC (831042325) |