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Lidocaine Hydrochloride 2%

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Active ingredient
Lidocaine Hydrochloride 2 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2026
Label revision date
February 12, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2026
Label revision date
February 12, 2026
Manufacturer
Aldermed Inc.
Registration number
M017
NDC root
87236-015
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 Hydrochloride is a medication used for the temporary relief of pain associated with minor burns and sunburn. It works by numbing the affected area, helping to alleviate discomfort and promote healing. If you're dealing with pain from these types of skin injuries, Lidocaine Hydrochloride may provide the soothing relief you need.

Uses

If you're looking for temporary relief from pain caused by minor burns or sunburn, this product may be suitable for you. It is specifically designed to help ease the discomfort associated with these types of skin injuries.

You can use it to soothe the affected areas, allowing for a more comfortable recovery. Remember, while it can provide relief, it's important to follow any additional care instructions for your skin.

Dosage and Administration

If you are an adult or a child aged 2 years and 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.

For children under 2 years of age, it’s important to consult a doctor before using this medication. They can provide the best advice tailored to your child's needs. Always prioritize safety and follow the recommended usage for effective treatment.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it on wounds or damaged skin, as this can lead to complications. Additionally, avoid using large quantities, especially on raw surfaces or blistered areas, to prevent irritation or adverse effects. Always follow these guidelines to ensure your safety and well-being.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should only use it externally and avoid applying it to wounds or damaged skin, especially in large amounts or on raw surfaces. Be careful to keep it away from your eyes and avoid wrapping the area tightly with a bandage.

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 consult a doctor. Additionally, if the product is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin, and do not use it in large amounts, especially on raw or blistered areas. While using this product, be careful not to get it in your eyes, and avoid wrapping the area tightly with a bandage.

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 consult your doctor. Keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly 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 hydrochloride gel during pregnancy has not been established. In fact, its use is generally not recommended due to potential risks to your developing baby. If you are considering using this gel, 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 provider to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can use Lidocaine Hydrochloride 2% Gel without specific warnings or recommendations against it. Currently, there is no information available about whether this medication passes into breast milk or if it poses any risk to your nursing infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

Pediatric Use

If 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. However, if your child is under 2 years old, it's important to consult a doctor before using this medication. 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 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, especially regarding any changes in health or concerns about side effects. Your safety and well-being are paramount, so don’t hesitate to ask questions or seek guidance tailored to your unique situation.

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 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 should be used 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 safety and effectiveness of your product, store it at room temperature. It's important to check the packaging before use; do not use the product if the seal is torn, cut, or opened, as this indicates it may have been tampered with. For your reference, the lot number and expiry date can be found on the sachet or carton, so be sure to check these details before using the product.

Additional Information

No further information is available.

FAQ

What is Lidocaine Hydrochloride used for?

Lidocaine Hydrochloride is used for the temporary relief of pain associated with minor burns and sunburn.

How should I apply Lidocaine Hydrochloride?

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

Are there any contraindications for using Lidocaine Hydrochloride?

Yes, do not use it on wounds or damaged skin, or in large quantities over raw surfaces or blistered areas.

What should I do if I experience worsening symptoms?

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

Is Lidocaine Hydrochloride safe to use during pregnancy?

The safety of Lidocaine Hydrochloride during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult your healthcare provider for advice.

What precautions should I take when using this product?

Avoid contact with the eyes and do not bandage tightly when using Lidocaine Hydrochloride.

What should I do if Lidocaine Hydrochloride is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

How should I store Lidocaine Hydrochloride?

Store at room temperature and do not use if the seal is torn, cut, or opened.

Packaging Info

Below are the non-prescription pack sizes of Lidocaine Hydrochloride 2% (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hydrochloride 2%.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine Hydrochloride 2%, 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 associated with minor burns and sunburn.

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 performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

Use is contraindicated on wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, application in large quantities, particularly over raw surfaces or blistered areas, is not recommended as it may exacerbate skin conditions or lead to further complications.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product on wounds or damaged skin, as well as in large quantities, particularly over raw surfaces or blistered areas.

While utilizing this product, it is crucial to avoid contact with the eyes. Additionally, patients should be instructed not to bandage the area tightly, as this may lead to adverse effects.

Healthcare professionals should counsel patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin and should not be used in large quantities, particularly over raw surfaces or blistered areas.

While using this product, patients are advised to avoid contact with the eyes and to refrain from tightly bandaging the area of application.

Patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 Lidocaine Hydrochloride 2% (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hydrochloride 2%.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 adverse effects or changes in therapeutic response, 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, it is essential for healthcare providers to be consulted for advice regarding its use.

Dosage modifications may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women should use lidocaine hydrochloride gel only if clearly needed and after thorough discussion with their healthcare provider to weigh the potential benefits against the risks.

Lactation

There are no specific warnings or recommendations regarding the use of Lidocaine Hydrochloride 2% Gel in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 this drug. Consequently, there are no 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 without delay. Contacting a Poison Control Center is recommended, with the national hotline available at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management procedures based on the severity of symptoms presented.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients to avoid contact with the eyes to prevent irritation or injury.

Patients should be informed not to bandage the affected area tightly, as this may exacerbate the condition. They should be counseled to discontinue use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms improve and then recur within a few days.

Healthcare providers should emphasize that the product should not be applied to wounds or damaged skin. Patients must also be cautioned against using the product in large quantities, especially over raw surfaces or blistered areas, to avoid potential adverse effects.

Storage and Handling

The product is supplied in a tamper-evident packaging. It is essential to inspect the seal before use; do not utilize the product if the seal is torn, cut, or opened.

Storage conditions require the product to be maintained at room temperature. For traceability, the lot number and expiry date can be found on the sachet or carton.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Lidocaine Hydrochloride 2%, 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 Hydrochloride 2%, 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.