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Lidodose

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 3 mg/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
October 4, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 3 mg/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
October 4, 2022
Manufacturer
Gensco Laboratories, LLC
Registration number
part348
NDC root
35781-0301
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

LIDO DOSE is a medication primarily used for pain relief. It is designed to help alleviate discomfort, making it a supportive option for those experiencing various types of pain. While the specific mechanism of action is not detailed, its main purpose is to provide you with relief from pain, helping you feel more comfortable in your daily activities.

Uses

This medication is primarily used for pain relief. It can help alleviate discomfort from various conditions, making it easier for you to manage your daily activities.

It's important to note that this medication does not have any known teratogenic effects, which means it is not expected to cause birth defects if taken during pregnancy. Additionally, there are no reported nonteratogenic effects, indicating that it is generally considered safe in this regard. Always consult with your healthcare provider for personalized advice and information.

Dosage and Administration

When using this medication, it's important to apply it correctly for the best results. If you are an adult or a child aged 2 years and older, start by putting on a pair of gloves. Before you take the swab out of its pouch, make sure to swirl the applicator tip. You should apply the medication to the affected area about 3 to 5 minutes before the procedure you are preparing for. Remember, you can use this medication no more than four times in a single day.

If you have a child under the age of 2, it's essential to consult a physician (doctor) before using this medication to ensure it's safe and appropriate for them.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

Side Effects

You should be aware that using local anesthetics can lead to a serious condition called methemoglobinemia. This occurs when the blood cannot carry oxygen effectively, and it can happen to anyone, though certain groups, such as infants under 6 months or those with specific health conditions, are at higher risk. Symptoms may appear right away or several hours later and include pale, gray, or blue skin (cyanosis), headaches, rapid heart rate, shortness of breath, lightheadedness, and fatigue.

If you or someone you care for experiences any of these symptoms, it’s crucial to stop using the anesthetic and seek immediate medical help. Prompt treatment is necessary to prevent more severe complications, including seizures or even death.

Warnings and Precautions

This product is for external use only, and you should avoid contact with your eyes. There is a risk of a serious condition called methemoglobinemia, which can affect anyone but is more likely to occur in certain individuals, such as infants under 6 months, those with specific genetic conditions, or those with heart or lung issues. Symptoms may appear right away or several hours later and include a bluish discoloration of the skin and blood. If you notice these symptoms, seek immediate medical attention, as untreated methemoglobinemia can lead to severe complications like seizures or even death.

If your condition worsens, or if symptoms last more than 7 days or return after improvement, stop using the product and consult your doctor. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center right away. Always use this product as directed and avoid applying it in large amounts, especially on broken skin or blisters.

Overdose

Using local anesthetics can sometimes lead to a condition called methemoglobinemia, where the blood is unable to carry oxygen effectively. While anyone can develop this condition, certain groups are at higher risk, including infants under 6 months, individuals with specific genetic conditions, and those with heart or lung issues. If you or someone you know is in one of these groups and requires local anesthetics, it’s important to monitor for symptoms closely.

Signs of methemoglobinemia can appear right away or may take a few hours to develop. Look for symptoms such as a bluish discoloration of the skin and unusual blood color. If you notice these signs, seek immediate medical attention, as untreated methemoglobinemia can lead to serious complications like seizures, coma, or even death. If an overdose occurs, stop using the local anesthetic and any other oxidizing agents right away. Treatment may involve supportive care, such as oxygen therapy and hydration, or more intensive interventions like methylene blue or hyperbaric oxygen, depending on the severity of the symptoms.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride gel during pregnancy has not been established. In fact, its use is generally not recommended because it may pose potential risks to your developing baby. If you are considering this treatment, please consult your physician for personalized advice and to discuss any associated risks.

Should you need to use lidocaine hydrochloride gel while pregnant, your healthcare provider may suggest dosage adjustments and will closely monitor your condition. They may also recommend alternative treatments that could be safer for you and your baby. Always prioritize open communication with your healthcare team to ensure the best outcomes for both you and your child.

Lactation Use

If you are breastfeeding and considering using LidoDose, it’s important to consult your physician first. This is because there is a possibility that the medication can be passed into your breast milk, which may affect your nursing infant. Therefore, exercising caution is advised when using this product while nursing. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If you have a child aged 2 years or older, you can apply this medication using a gloved hand. Make sure to swirl the applicator tip before taking the swab out of the pouch, and apply it to the affected area 3 to 5 minutes before the procedure, but no more than four times a day. For children under 2 years old, it's important to consult a physician before use.

Be aware that certain conditions can make children more vulnerable to side effects. If your child has glucose-6-phosphate dehydrogenase deficiency (a genetic condition affecting red blood cells), congenital or idiopathic methemoglobinemia (a blood disorder), or any heart or lung issues, or if they are infants under 6 months old, they may be at higher risk for complications. In these cases, close monitoring for symptoms of methemoglobinemia (a condition where there is too much methemoglobin in the blood) is recommended.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to be aware that if you are receiving local anesthetics, you may have an increased risk of a condition called methemoglobinemia, especially if you are also using certain other medications. This includes various oxidizing agents like nitrates (such as nitroglycerin) and certain antibiotics, antimalarials, and even some common pain relievers like acetaminophen.

To ensure your safety, always discuss all medications you are taking with your healthcare provider. They can help you understand any potential interactions and adjust your treatment plan as needed. Being open about your medications can help prevent complications and ensure you receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 68 and 77°F (20 - 25°C). It’s acceptable for the temperature to occasionally range from 59 to 86°F (15 - 30°C), but be sure to avoid exposing the product to freezing temperatures, as this can damage it.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Proper storage and careful handling will help ensure that the product remains safe and effective for your use.

Additional Information

Using local anesthetics can lead to a serious condition called methemoglobinemia, which requires prompt treatment. It's important for you or your caregivers to be aware of the signs and symptoms of this condition. If you notice pale, gray, or blue-colored skin (known as cyanosis), along with headache, rapid heart rate, shortness of breath, lightheadedness, or fatigue, stop using the anesthetic immediately and seek medical attention.

FAQ

What is LidoDose used for?

LidoDose is used for pain relief.

How should I apply LidoDose?

For adults and children 2 years and older, apply using a gloved hand, swirl the applicator tip before removing the swab, and apply to the area 3-5 minutes prior to the procedure, not more than 4 times daily.

What should I do if I experience symptoms of methemoglobinemia?

If you experience symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, lightheadedness, or fatigue, stop using LidoDose and seek immediate medical attention.

Is LidoDose safe to use during pregnancy?

The safety of LidoDose during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

Can nursing mothers use LidoDose?

Nursing mothers should consult a physician before using LidoDose, as there is a potential for excretion in breast milk.

Are there any contraindications for using LidoDose?

There are no specific contraindications listed for LidoDose, but it is contraindicated in pregnancy.

What should I do if I swallow LidoDose?

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

What are the storage conditions for LidoDose?

Store LidoDose between 68 and 77°F (20 - 25°C), with allowed excursions between 59 and 86°F (15 - 30°C), and protect it from freezing.

Packaging Info

Below are the non-prescription pack sizes of Lidodose (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidodose.
Details

Drug Information (PDF)

This file contains official product information for Lidodose, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

LIDO DOSE is a local anesthetic with the chemical name 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide hydrochloride. It appears as a white to off-white crystalline powder and is soluble in both water and alcohol. The formulation includes inactive ingredients such as sodium chloride, hydrochloric acid, and water for injection. The SPL code for LIDO DOSE is 34089-3.

Uses and Indications

This drug is indicated for the relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 2 years and older, the medication should be applied using a gloved hand. Prior to removing the swab from the pouch, it is essential to swirl the applicator tip. The application should occur 3 to 5 minutes before the procedure, with a maximum frequency of four times daily.

For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. The use of local anesthetics has been associated with cases of methemoglobinemia. While all patients are at risk, certain populations are particularly susceptible, including those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, individuals with cardiac or pulmonary compromise, infants under 6 months of age, and patients exposed to oxidizing agents or their metabolites. In these patients, close monitoring for symptoms and signs of methemoglobinemia is essential.

Signs and symptoms of methemoglobinemia may manifest immediately or may be delayed for several hours post-exposure. These symptoms are characterized by cyanotic skin discoloration and abnormal blood coloration. It is critical to recognize that methemoglobin levels can continue to rise, necessitating immediate intervention to prevent severe central nervous system and cardiovascular complications, which may include seizures, coma, arrhythmias, and potentially fatal outcomes. In the event of methemoglobinemia, LidoDose and any other oxidizing agents should be discontinued. Supportive care, such as oxygen therapy and hydration, may be beneficial, while more severe cases may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen therapy.

Healthcare professionals should also ensure that the product does not come into contact with the eyes, as this may lead to further complications.

Patients should be advised to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Caution is advised against using large quantities, especially over raw surfaces or blistered areas.

In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Cases of methemoglobinemia have been reported in association with the use of local anesthetics. All patients are at risk for this condition; however, certain populations are more susceptible, including those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and individuals with concurrent exposure to oxidizing agents or their metabolites.

Signs and symptoms of methemoglobinemia may manifest immediately or may be delayed for several hours following exposure. These symptoms are characterized by cyanotic skin discoloration and abnormal coloration of the blood. It is important to note that methemoglobin levels may continue to rise, necessitating immediate treatment to prevent more serious central nervous system and cardiovascular adverse effects, which can include seizures, coma, arrhythmias, and death. In the event of methemoglobinemia, it is critical to discontinue LidoDose and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care such as oxygen therapy and hydration. More severe cases may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

Patients and caregivers should be counseled on the potential for methemoglobinemia as a serious condition that requires prompt treatment. They should be advised to seek immediate medical attention if they or someone in their care experiences any of the following signs or symptoms: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, lightheadedness, or fatigue.

Drug Interactions

Patients receiving local anesthetics may experience an increased risk of methemoglobinemia when concurrently administered with certain oxidizing agents. The following drug classes and specific agents have been identified as potential contributors to this risk:

Nitrates and Nitrites

  • Agents: Nitroglycerin, nitroprusside, nitric oxide, nitrous oxide

  • Clinical Effect: These agents can enhance the risk of methemoglobinemia when used alongside local anesthetics.

Local Anesthetics

  • Agents: Benzocaine, lidocaine, bupivacaine, inepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine

  • Clinical Effect: The use of these local anesthetics in conjunction with oxidizing agents may lead to elevated levels of methemoglobin.

Antineoplastic Agents

  • Agents: Cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea

  • Clinical Effect: Co-administration with local anesthetics may increase the risk of methemoglobinemia.

Antibiotics

  • Agents: Dapsone, sulfonamides, nitrofurantoin, para-aminosalicylic acid

  • Clinical Effect: These antibiotics can also contribute to the risk of methemoglobinemia when used with local anesthetics.

Antimalarials

  • Agents: Chloroquine, primaquine

  • Clinical Effect: The combination of these antimalarials with local anesthetics may elevate the risk of methemoglobinemia.

Anticonvulsants

  • Agents: Phenytoin, sodium valproate, phenobarbital

  • Clinical Effect: Concurrent use with local anesthetics may increase the likelihood of methemoglobinemia.

Other Drugs

  • Agents: Acetaminophen, metoclopramide, sulfa drugs (e.g., sulfasalazine), quinine

  • Clinical Effect: These medications may also pose a risk for methemoglobinemia when administered alongside local anesthetics.

It is advisable for healthcare professionals to monitor patients closely for signs of methemoglobinemia when local anesthetics are used in conjunction with any of the aforementioned agents. Dosage adjustments may be necessary based on the clinical scenario and the specific agents involved.

Packaging & NDC

Below are the non-prescription pack sizes of Lidodose (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidodose.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by applying it with a gloved hand. The applicator tip should be swirled prior to removing the swab from the pouch, and the product should be applied to the area 3-5 minutes before the procedure, not exceeding four times daily.

For children under 2 years of age, consultation with a physician is advised prior to use.

Pediatric patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and infants under 6 months of age are at increased risk for developing clinical manifestations of methemoglobinemia. Close monitoring for symptoms and signs of methemoglobinemia is recommended in these populations, especially in those with concurrent exposure to oxidizing agents or their metabolites.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine hydrochloride gel during pregnancy has not been established. Its use is contraindicated in pregnant patients due to potential risks to the fetus. There may be associated risks with the use of lidocaine hydrochloride gel during pregnancy; therefore, consultation with a physician is advised for further guidance.

Dosage modifications may be necessary for pregnant patients, and healthcare providers should be consulted for specific recommendations. Additionally, pregnant patients should be closely monitored if lidocaine hydrochloride gel is utilized, and alternative treatments should be considered to mitigate any potential risks.

Lactation

Lactating mothers should consult a physician before using LidoDose. There is a potential for excretion of the product in breast milk. Caution is advised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data necessitates careful evaluation of potential risks and benefits.

Overdosage

In cases of overdosage associated with local anesthetic use, methemoglobinemia has been reported as a significant concern. While all patients are at risk for developing this condition, certain populations are particularly susceptible. These include individuals with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, those with cardiac or pulmonary compromise, infants under 6 months of age, and patients who have concurrent exposure to oxidizing agents or their metabolites.

For patients in these high-risk categories, it is imperative to implement close monitoring for symptoms and signs of methemoglobinemia if local anesthetics are administered. The onset of signs and symptoms may occur immediately or may be delayed for several hours post-exposure. Clinically, methemoglobinemia is characterized by cyanotic skin discoloration and abnormal coloration of the blood.

It is crucial to recognize that methemoglobin levels can continue to rise, necessitating immediate intervention to prevent more severe central nervous system and cardiovascular complications, which may include seizures, coma, arrhythmias, and potentially fatal outcomes. In the event of suspected overdosage, the administration of LidoDose and any other oxidizing agents should be discontinued without delay.

Management of methemoglobinemia may vary based on the severity of symptoms. Supportive care, such as oxygen therapy and hydration, may be sufficient for mild cases. However, more severe manifestations may require advanced treatment options, including methylene blue administration, exchange transfusion, or hyperbaric oxygen therapy. Prompt recognition and appropriate management are essential to mitigate the risks associated with methemoglobinemia in the context of local anesthetic overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should inform patients that the use of local anesthetics may lead to methemoglobinemia, a serious condition that requires prompt treatment. It is essential for patients or their caregivers to be aware of the signs and symptoms associated with this condition.

Advise patients to seek immediate medical attention if they or someone in their care experiences any of the following: pale, gray, or blue-colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. Emphasizing the importance of recognizing these symptoms can facilitate timely intervention and improve patient outcomes.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 68 to 77°F (20 to 25°C), with permissible excursions between 59 and 86°F (15 to 30°C). It is essential to protect the product from freezing to maintain its integrity and efficacy. Proper storage conditions must be adhered to in order to ensure optimal performance.

Additional Clinical Information

Patients should be informed that the use of local anesthetics may lead to methemoglobinemia, a serious condition requiring prompt treatment. It is essential for patients or their caregivers to discontinue use and seek immediate medical attention if they observe any of the following signs or symptoms: pale, gray, or blue-colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Drug Information (PDF)

This file contains official product information for Lidodose, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Lidodose, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.