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0.5% Lidocaine Burn Relief

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Active ingredient
Lidocaine Hydrochloride 0.5 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 21, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.5 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 21, 2026
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-099
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

0.5% Lidocaine Burn Relief is a topical medication designed to provide temporary relief from pain and itching caused by various skin irritations. You can use it for minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations.

This product contains lidocaine, which works by numbing the affected area, helping to alleviate discomfort and promote healing. If you're dealing with any of these skin issues, 0.5% Lidocaine Burn Relief may help soothe your symptoms.

Uses

If you're dealing with minor burns, sunburn, cuts, scrapes, insect bites, or other minor skin irritations, this product can help provide temporary relief from pain and itching. It's designed to soothe your skin and make you feel more comfortable during those bothersome moments.

Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) or nonteratogenic effects (which refers to other types of harm) associated with this product. You can use it with confidence for your minor skin issues.

Dosage and Administration

If you or your child is 2 years old or older and need to use this medication, you can apply it 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 with a doctor before using the medication. This will help ensure safety and effectiveness for younger children. Always follow your healthcare provider's advice regarding the use of any medication.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

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

Additionally, 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 intended for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered surfaces. Be careful to keep it away from your eyes, as contact can cause irritation.

If your condition worsens, or if your symptoms last longer than 7 days or return shortly after improvement, stop using the product and consult your doctor. It's also important to keep this product out of reach of children. If a child accidentally swallows it, 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. 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 require prompt attention. Always err on the side of caution and reach out for help if you are unsure about the situation. Your safety is the top priority.

Pregnancy Use

Currently, there is no information available about the use of 0.5% Lidocaine Burn Relief during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert. If you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before using this product to ensure your safety and the safety of 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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. 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 aged 2 years and older, you can apply it 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 use. This ensures that the treatment is safe and appropriate for your little one. Always follow these guidelines to help keep your child healthy and safe.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

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 provide guidance based on your individual situation.

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 (issues with liver function).

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

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from direct sunlight. This helps maintain its effectiveness and safety.

When handling the product, be sure to keep it in a clean environment to avoid contamination. If you have any specific disposal instructions, follow those carefully to ensure safe and responsible disposal.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. Always follow the recommended application guidelines for safe and effective treatment.

FAQ

What is 0.5% Lidocaine Burn Relief used for?

0.5% Lidocaine Burn Relief is used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I apply 0.5% Lidocaine Burn Relief?

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 this product?

There are no contraindications listed for 0.5% Lidocaine Burn Relief.

What precautions should I take when using this product?

Use only for external application, avoid large quantities on raw surfaces or blistered areas, and avoid contact with the eyes. If symptoms worsen or persist for more than 7 days, consult a doctor.

What should I do if I swallow this product?

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

Is it safe to use during pregnancy or while nursing?

There is no specific information regarding the use of 0.5% Lidocaine Burn Relief during pregnancy or nursing, so consult a healthcare provider for advice.

How should I store 0.5% Lidocaine Burn Relief?

Store at room temperature and protect from direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of 0.5% Lidocaine Burn Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 0.5% Lidocaine Burn Relief.
Details

Drug Information (PDF)

This file contains official product information for 0.5% Lidocaine Burn Relief, 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 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, it is advised to consult a physician prior to use. This precaution is essential to ensure safety and appropriateness of treatment for this age group.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

This product is intended for external use only. It is imperative that users refrain from applying it in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Care should be taken to avoid contact with the eyes during application. In the event of eye contact, immediate rinsing with water is recommended. Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

To ensure safety, this product must be kept out of reach of children. In the case of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only and should not be applied in large quantities, particularly over raw surfaces or blistered areas. Care should be taken to avoid contact with the eyes during application.

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

Additionally, it is important to keep this product out of reach of children. If ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

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 0.5% Lidocaine Burn Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 0.5% Lidocaine Burn Relief.
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 infants and children under 2 years of age, it is advised to consult a physician before 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

There is no information available regarding the use of 0.5% Lidocaine Burn Relief during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should consider this lack of data when prescribing this medication to pregnant patients. The potential risks to fetal outcomes remain undetermined due to the absence of clinical or animal studies addressing the effects of this drug in pregnant women. Therefore, women of childbearing potential should be advised to discuss their pregnancy status and any potential risks with their healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by 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 the use of this medication. 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 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.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

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 at room temperature, ensuring that it is protected from direct sunlight to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

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 of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 0.5% Lidocaine Burn Relief, 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 0.5% Lidocaine Burn Relief, 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.