Lidodose

Manufacturer
Gensco Laboratories, LLC
Effective date
2022-10-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:50:55

Label at a glance#

ProductLidodose
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Dosage and administration

Adults and children 2 years of age and older: Apply using a gloved hand. Swirl the applicator tip prior to removing swab from the pouch and apply to area 3-5 minutes prior to procedure not more than 4 times daily. Children under 2 years of age: consult a physician.

Storage and handling

Store between 68 and 77 F (20 - 25 C), with allowed excursions between 59 and 86 F (15 - 30 C). Protect from freezing. (See USP Controlled Room Temperature).

Label contents#

Full prescribing information#

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Apply using a gloved hand. Swirl the applicator tip prior to removing swab from the pouch and apply to area 3-5 minutes prior to procedure not more than 4 times daily.

Children under 2 years of age: consult a physician.

Usage

INDICATIONS & USAGE SECTION

Pain relief

Warning: for external use only.

WARNINGS SECTION

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

DRUG INTERACTIONS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Storage

STORAGE AND HANDLING SECTION

Store between 68 and 77 F (20 - 25 C), with allowed excursions between 59 and 86 F (15 - 30 C). Protect from freezing. (See USP Controlled Room Temperature).

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.

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 3%

Purpose:

OTC - PURPOSE SECTION

Anesthetic

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Carbomer, Isopropyl Alcohol, Petrolatum, Polysorbate-20, Triethanolamine

SPL UNCLASSIFIED SECTION

Please see product insert for additional information.

LIDO DOSE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton
Carton
Insert
Insert
Label
Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35781-0301-0Lidodose1 mL in 1 POUCHGEL17
35781-0301-1Lidodose100 in 1 BOXGEL1007
35781-0301-5Lidodose25 in 1 BOXGEL257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35781-0301LIDODOSE (LIDOCAINE HYDROCHLORIDE) GEL [GENSCO LABORATORIES, LLC]7Legacy NDC, 3 package rows20221006_0b3e8433-4f93-4f01-9df0-020fb6922bce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35781-0301-0ML - Milliliter35781-0301ffc9fee0-57af-4fd1-bdfe-2944d888a28312018-08-13
35781-0301-1ML - Milliliter35781-0301ee48ab42-3c99-400e-ad2a-4cf6a13cb5f812019-04-11
35781-0301-5ML - Milliliter35781-0301cf10e88e-9a11-4224-9050-ee0310a8b30912018-08-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35781-030135781-0301-0, 35781-0301-5, 35781-0301-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ea3b2c15-c1c6-c4ea-e053-2995a90a1dae0b3e8433-4f93-4f01-9df0-020fb6922bce2022-10-04WarningsExact identifier
spl id: ea3b2c15-c1c6-c4ea-e053-2995a90a1dae
spl set id: 0b3e8433-4f93-4f01-9df0-020fb6922bce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.