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Leader

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 19, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 19, 2024
Manufacturer
Cardinal Health
Registration number
M017
NDC root
70000-0098
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 4% Topical Analgesic is a pain relief cream designed to temporarily relieve pain and itching. It is a non-greasy formulation that can be used for various minor skin issues, including minor burns, sunburn, cuts, scrapes, insect bites, and other minor skin irritations.

This cream works by numbing the affected area, providing you with soothing relief from discomfort. With a convenient size of 2.7 oz (76.5g), it’s easy to apply whenever you need it.

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 use.

Dosage and Administration

If you or your child is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. However, if your child is under 2 years old, it’s important to consult a doctor before using the medication. This will help ensure safety and effectiveness for younger children.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it in large amounts, especially on raw or blistered skin, as this could lead to irritation or other complications. Additionally, be careful to keep the product away from your eyes, as contact can cause discomfort or harm.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your experience is safe and effective.

Side Effects

This product is intended for external use only, so be sure to avoid applying it in large amounts, especially on raw or blistered skin. While using it, take care not to get it in your eyes. If your condition worsens, lasts longer than seven days, or improves only to return within a few days, stop using the product and consult a doctor.

Keep this product out of reach of children. If it is swallowed, seek medical assistance 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. Be careful not to get the product in your eyes, as this can cause irritation.

If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days, stop using the product and contact your doctor for advice. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine HCl cream during pregnancy has not been established. This medication is generally not recommended for use while pregnant due to potential risks to your developing baby. If you are considering using this cream, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

Additionally, if your healthcare provider does recommend its use, be aware that dosage adjustments may be needed. Always prioritize open communication with your healthcare team to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply it to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

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, it’s important to consult with a healthcare provider for personalized advice. 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 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 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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best 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

You can use this medication topically, applying it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Lidocaine HCl 4% Topical Analgesic used for?

Lidocaine HCl 4% Topical Analgesic is used to temporarily relieve pain and itching due to minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I apply Lidocaine HCl cream?

For adults and children 2 years and over, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for using this product?

There are no specific contraindications mentioned, but it should not be used in large quantities, particularly over raw surfaces or blistered areas.

What should I do if I experience worsening symptoms?

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

Is Lidocaine HCl safe to use during pregnancy?

The safety of Lidocaine HCl cream during pregnancy has not been established, and it may pose risks to the fetus. Consult your healthcare provider for advice.

What precautions should I take when using this product?

Use Lidocaine HCl cream only for external use, avoid contact with eyes, and keep it out of reach of children. If swallowed, seek medical help immediately.

What is the storage requirement for Lidocaine HCl cream?

Store the cream between 20 °C and 25 °C (68 °F and 77 °F).

Are there any known drug interactions with Lidocaine HCl?

No specific drug interactions are mentioned for Lidocaine HCl cream.

Packaging Info

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

Packaging configurations for Leader.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Lidocaine HCl 4% is a topical analgesic formulated as a non-greasy cream. The active ingredient, lidocaine, provides localized pain relief. Each container has a net weight of 2.7 oz (76.5 g).

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 2 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 product.

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

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 lead to serious ocular complications.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied in large quantities, especially on raw surfaces or blistered areas, to prevent adverse effects.

Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of accidental exposure, immediate rinsing with water is recommended.

Patients should be instructed 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 recur within a few days. These actions are crucial to ensure appropriate management of the patient's condition.

Additionally, this product must be kept out of reach of children. In the case of ingestion, it is essential to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt action is necessary to mitigate potential risks associated with accidental swallowing.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects. Care should be taken to prevent the product from coming into contact with the eyes.

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

Additionally, this product should be kept out of reach of children. If swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Leader.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 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 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

The safety of lidocaine HCl cream during pregnancy has not been established. Lidocaine is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for advice before use.

Dosage adjustments may be necessary for pregnant individuals, and medical guidance should be sought to determine the appropriate course of action. Pregnant women should use this product only if clearly needed and after discussing the potential risks and benefits with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 this 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 their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, patients should be informed to avoid contact with the eyes while using this product, as it may cause irritation or other complications.

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 a suitable container to protect it from environmental factors. Special handling requirements should be observed to preserve the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years, it is advised to consult a physician before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Leader, 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, 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.