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Leader Lidocaine

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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 2021
Label revision date
December 3, 2025
Manufacturer
CARDINAL HEALTH
Registration number
M017
NDC root
70000-0099
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Lidocaine HCl is a 4% topical analgesic, which means it is a medication applied to the skin to help relieve pain and itching. It works by temporarily numbing the area where it is applied, making it effective for treating minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations.

This liquid formulation comes with a convenient applicator designed for easy use without mess. If you're looking for relief from minor skin discomforts, Lidocaine HCl may be a helpful option to consider.

Uses

You can use this medication to temporarily relieve pain and itching caused by various skin issues. It is effective for minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations. This means that if you experience discomfort from any of these conditions, this product can help soothe your skin and provide some relief.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can apply the medication to the affected area up to three to four times a day. Make sure to follow this guideline to ensure the best results.

For children under 12 years old, it’s important to consult a doctor before using this medication. They can provide the appropriate advice and dosage tailored to your child's needs. Always prioritize safety and follow professional guidance when it comes to medication for younger individuals.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not use it in large quantities, especially on raw surfaces or blistered areas, as this could lead to irritation or other complications. Additionally, be careful not to get the product into your eyes, as this can cause discomfort or harm.

By following these guidelines, you can help ensure a safe and effective experience with the product. If you have any concerns or questions, don't hesitate to reach out for more information.

Side Effects

This product is intended for external use only, so please avoid applying it to large areas, especially over raw or blistered skin. Be careful not to get it in your eyes. If you notice that your condition worsens, symptoms persist for more than seven days, or if symptoms improve and then return within a few days, stop using the product and consult a doctor.

Additionally, this product is flammable, so keep it away from fire or flames. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on large areas of your skin, especially over raw or blistered surfaces. It's important to remember that this product is flammable, so keep it away from fire or flames.

If you accidentally swallow this product, seek medical help immediately or contact a Poison Control Center. You should also stop using the product and call your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning optimally.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20 °C and 25 °C (68 °F and 77 °F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What is Lidocaine HCl?

Lidocaine HCl is a 4% topical analgesic used to temporarily relieve pain and itching.

What conditions can Lidocaine HCl be used for?

It is indicated for minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I use Lidocaine HCl?

Adults and children 12 years and over should apply it to the affected area not more than 3 to 4 times daily. Children under 12 years should ask a doctor.

Are there any warnings for using Lidocaine HCl?

Yes, it is for external use only, should not be used in large quantities over raw surfaces or blistered areas, and should not get into the eyes.

What should I do if I swallow Lidocaine HCl?

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

What should I do if my condition worsens or does not improve?

Stop use and ask a doctor if your condition gets worse, symptoms last for more than 7 days, or if symptoms clear up and occur again within a few days.

Is Lidocaine HCl safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

How should I store Lidocaine HCl?

Store Lidocaine HCl between 20 °C and 25 °C (68 °F and 77 °F).

Is there a money-back guarantee for Lidocaine HCl?

Yes, there is a 100% money-back guarantee.

Packaging Info

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

Packaging configurations for Leader Lidocaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The application should be performed with clean hands, ensuring that the area is dry before applying the medication.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for irritation or adverse effects. Additionally, it is contraindicated to allow the product to come into contact with the eyes, as this may result in significant discomfort or injury.

Warnings and Precautions

For external use only; this product should not be applied in large quantities, especially on raw surfaces or blistered areas.

It is imperative to note that the product is flammable; therefore, it must be kept away from fire or flame to prevent any hazardous incidents.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then reappear within a few days. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects. During use, care should be taken to prevent contact with the eyes.

In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days, patients are advised to stop use and consult a healthcare professional.

Additionally, the product is flammable; therefore, it should be kept away from fire or flame to prevent any hazardous situations.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use.

To ensure safety, this product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Leader Lidocaine.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, patients should be reminded to avoid contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within the temperature range of 20 °C to 25 °C (68 °F to 77 °F) to ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in its original container to protect it from environmental factors. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Leader Lidocaine, 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 Leader Lidocaine, 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.

Learn more in our Editorial Policy

Last AI update:

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.