Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Lidocaine 3%

Last content change checked dailysee data sync status

Active ingredient
Lidocaine Hydrochloride 30 mg/1 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 2025
Label revision date
August 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 30 mg/1 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 2025
Label revision date
August 12, 2025
Manufacturer
PureTek Corporation
Registration number
M017
NDC root
59088-241
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 3% Cream is a topical medication designed to provide temporary relief from pain and itching caused by various skin conditions. You can use it for minor burns, sunburn, cuts, scrapes, insect bites, skin irritations, and rashes resulting from poison ivy, poison oak, or poison sumac.

This cream works by numbing the affected area, helping to alleviate discomfort and promote healing. If you're dealing with any of these minor skin issues, Lidocaine 3% Cream may be a helpful option for you.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. It is effective for minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. Additionally, it can help soothe rashes that result from contact with poison ivy, poison oak, or poison sumac.

This product is designed to provide quick comfort for these common skin problems, allowing you to feel better and get back to your daily activities.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area of your skin 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 not to use this medication without first consulting a licensed healthcare practitioner. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the guidance provided by your healthcare professional to ensure safe and effective use.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and refrain from applying it in large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last more than seven days or return shortly after improvement, stop using the product and consult a healthcare professional.

Additionally, please keep this and all medications out of the reach of children to ensure their safety.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. It's important not to use large amounts, especially on raw or blistered skin.

If your condition worsens, or if your symptoms last more than 7 days or come back after clearing up, stop using the product and consult a healthcare professional. Always keep this and any other medications out of reach of children to ensure their safety.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your local poison control center or going to the nearest emergency room is crucial. They can provide the necessary guidance and treatment. Always remember that it's better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. They can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can use Lidocaine 3% Cream without specific warnings or recommendations regarding its use while nursing. The information available does not indicate any particular precautions or considerations for lactation. This means that, based on the current data, it is generally considered safe for nursing mothers to use this cream. However, always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a licensed healthcare practitioner (a qualified medical professional).

Always ensure you adhere to these recommendations to keep your child safe and healthy. If you have any questions or concerns about using this medication for your child, don't hesitate to reach out to your healthcare provider for guidance.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver 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 standard recommendations for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.

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 discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20º-25ºC (68º-77ºF). This range is considered a controlled room temperature, which helps maintain the integrity of the device.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If your child is under 2 years old, do not use this medication without consulting a licensed healthcare practitioner. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Lidocaine 3% Cream used for?

Lidocaine 3% Cream is used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac.

How should I apply Lidocaine 3% Cream?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it and should consult a licensed healthcare practitioner.

Are there any contraindications for using Lidocaine 3% Cream?

There are no contraindications listed for Lidocaine 3% Cream.

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

You should stop using the cream and consult a licensed healthcare practitioner if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is Lidocaine 3% Cream safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Lidocaine 3% Cream during pregnancy or lactation.

What precautions should I take when using Lidocaine 3% Cream?

Use Lidocaine 3% Cream for external use only, avoid contact with the eyes, and do not use in large quantities, particularly over raw surfaces or blistered areas.

How should I store Lidocaine 3% Cream?

Store Lidocaine 3% Cream at 20º-25ºC (68º-77ºF) to maintain its effectiveness.

What should I do if I accidentally use too much Lidocaine 3% Cream?

If you use Lidocaine 3% Cream in large quantities or over raw surfaces, you should seek advice from a healthcare practitioner.

Is there any information about drug interactions with Lidocaine 3% Cream?

No specific drug interactions are mentioned for Lidocaine 3% Cream.

What should I keep in mind regarding children and Lidocaine 3% Cream?

Keep Lidocaine 3% Cream out of reach of children and do not use it on children under 2 years of age without consulting a healthcare practitioner.

Packaging Info

Below are the non-prescription pack sizes of Lidocaine 3% (lidocaine hcl 3%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine 3%.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine 3%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Lidocaine 3% Cream is a topical formulation containing lidocaine as the active ingredient. Lidocaine is a local anesthetic that provides temporary relief from pain and discomfort. The cream is designed for external use and is characterized by its creamy consistency, allowing for easy application to the skin. The concentration of lidocaine in this formulation is 3%, which is intended to achieve effective local anesthesia at the site of application.

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, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac.

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. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a licensed healthcare practitioner. Healthcare professionals are advised to evaluate the necessity and safety of treatment in this age group before proceeding with any application.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, especially over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

Healthcare professionals should advise patients to discontinue use and consult a licensed healthcare practitioner if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, it is crucial to keep this product and all other medications out of the reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes during application. Additionally, the use of this product in large quantities, particularly over raw surfaces or blistered areas, is not recommended.

In the event that the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, patients are advised to discontinue use and consult a licensed healthcare practitioner.

Furthermore, it is crucial to keep this and all other drugs out of the reach of children to prevent accidental ingestion or misuse.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Lidocaine 3% (lidocaine hcl 3%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine 3%.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; consultation with a licensed healthcare practitioner is advised.

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.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly, and alternative treatment options may need to be considered in the context of pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Lidocaine 3% Cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this and all other medications out of the reach of children to prevent accidental ingestion.

Patients should be informed that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product and consult a licensed healthcare practitioner for further evaluation and guidance.

It is important to instruct patients to avoid contact with the eyes while using this product, as this may lead to irritation or other adverse effects.

Additionally, healthcare providers should caution patients against using the product in large quantities, especially over raw surfaces or blistered areas, to minimize the risk of adverse reactions.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature of 20º-25ºC (68º-77ºF), as defined by the United States Pharmacopeia (USP) guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. It is contraindicated for use in children under 2 years of age, and clinicians are advised to consult a licensed healthcare practitioner for such cases. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Lidocaine 3%, 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 Lidocaine 3%, 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.