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2.0% Lidocaine Burn

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Active ingredient
Lidocaine Hydrochloride 2 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
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
January 8, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
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
January 8, 2026
Manufacturer
Universal Distribution Center LLC
Registration number
M017
NDC root
52000-441
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

2.0% Lidocaine Burn is a topical medication designed to provide temporary relief from pain associated with minor burns. It works by numbing the affected area, helping to alleviate discomfort and promote a sense of comfort during the healing process. If you are dealing with minor burns, this product may help ease your pain and support your recovery.

Uses

If you're dealing with minor burns, this medication can provide temporary relief from the pain. It's designed to help ease discomfort, allowing you to feel more comfortable while your skin heals. Remember, this is specifically for minor burns, so if you have more serious injuries, it's important to seek medical attention.

Dosage and Administration

To use the burn spray effectively, start by cleaning the affected area thoroughly. Once it’s clean, spray an even layer of the burn spray over the area. You can do this up to 3 to 4 times a day, depending on your needs.

Please note that this product is not suitable for children under 12 years of age, so make sure to keep it out of their reach. Always follow these guidelines to ensure safe and effective use of the burn spray.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication, but always use it responsibly and as directed.

Side Effects

You should be aware that this product is for external use only. Avoid using it in large amounts, especially on raw or blistered skin, and keep it away from your eyes—if it accidentally gets in your eyes, rinse thoroughly with water. If your condition worsens, lasts more than 7 days, or clears up and then returns, stop using the product and consult a doctor.

It's also important to keep this product out of reach of children. If a child swallows it, 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 in large amounts, especially on raw or blistered skin. Be careful not to apply it near your eyes; if it does get in your eyes, rinse them thoroughly with water. If your condition worsens, lasts more than 7 days, or improves and then comes back, stop using the product and consult your doctor.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. If you ever swallow the product yourself, get medical help right away.

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 reach out for professional assistance if you have any concerns about an overdose. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride spray during pregnancy has not been established. There are potential risks associated with its use, including possible adverse effects on fetal development. Because of these concerns, lidocaine is generally not recommended for use during pregnancy.

If you feel that you may need to use this product, it is crucial to consult your healthcare provider first. They may suggest dosage adjustments and will help you weigh the benefits against any potential risks. Always prioritize open communication with your healthcare team to ensure the best outcomes 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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

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

Pediatric Use

It's important to know that this medication should not be used in children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that are safe and appropriate for their age. Always prioritize your child's health and follow medical advice regarding their treatment.

Geriatric Use

When considering medication for older adults, it's important to note that this particular drug should not be used in children under 12 years of age. If you are caring for an older adult, ensure that any medications are appropriate for their age and health status. Always consult with a healthcare provider to discuss any specific concerns or questions regarding medication use in older individuals.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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 apply, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and 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 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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

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

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You should apply the burn spray topically, which means you will spray an even layer over the cleaned affected area. It is recommended to do this no more than 3 to 4 times a day for best results. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available at this time.

FAQ

What is 2.0% Lidocaine Burn used for?

2.0% Lidocaine Burn is used for temporary pain relief associated with minor burns.

How should I use 2.0% Lidocaine Burn?

You should spray an even layer of the burn spray over the cleaned affected area no more than 3-4 times daily.

Is 2.0% Lidocaine Burn safe for children?

No, it should not be used on children under 12 years of age.

What should I do if 2.0% Lidocaine Burn is swallowed?

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

Are there any warnings for using 2.0% Lidocaine Burn?

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

What should I do if my condition worsens while using 2.0% Lidocaine Burn?

Stop use and ask a doctor if the condition worsens or persists for more than 7 days or clears up and returns.

Can pregnant women use 2.0% Lidocaine Burn?

The safety of lidocaine during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What precautions should pregnant women take when using 2.0% Lidocaine Burn?

Pregnant women should use this product only if clearly needed and after discussing it with their healthcare provider.

Is there any information about using 2.0% Lidocaine Burn while nursing?

There are no specific warnings or recommendations regarding its use in nursing mothers.

What is the recommended storage temperature for 2.0% Lidocaine Burn?

Store 2.0% Lidocaine Burn at 68°-77°F (20°-25°C).

Packaging Info

Below are the non-prescription pack sizes of 2.0% Lidocaine Burn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 2.0% Lidocaine Burn.
Details

Drug Information (PDF)

This file contains official product information for 2.0% Lidocaine Burn, 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. It is intended for use in patients experiencing discomfort due to such injuries.

Dosage and Administration

Healthcare professionals are advised to apply an even layer of the burn spray to the cleaned affected area. This application should not exceed 3 to 4 times daily.

It is important to note that this product is contraindicated for use in children under 12 years of age.

Contraindications

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

Warnings and Precautions

For external use only. It is imperative that this product not be applied in large quantities, particularly over raw or blistered areas. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the eyes should be rinsed thoroughly with water.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens or persists for more than 7 days, or if the condition appears to improve and then returns.

General precautions must be observed, including keeping the product out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

In cases of accidental swallowing, it is crucial to obtain emergency medical help or contact a Poison Control Center without delay.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use in large quantities, particularly over raw or blistered areas, and should not be applied near the eyes. In the event of contact with the eyes, it is advised to rinse thoroughly with water.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

Additionally, the product should 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 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 2.0% Lidocaine Burn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 2.0% Lidocaine Burn.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals should consider alternative treatments for pediatric patients who fall within this age range.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should assess the overall health status and specific needs of geriatric patients, as age-related physiological changes may affect drug metabolism and response. Monitoring for potential adverse effects and therapeutic efficacy is recommended, particularly in this population.

Dosage adjustments may be necessary based on individual patient factors, including renal and hepatic function, which can be impacted by aging. Therefore, close observation and appropriate modifications to the treatment regimen should be considered to ensure safety and effectiveness in elderly patients.

Pregnancy

The safety of lidocaine hydrochloride spray during pregnancy has not been established. Lidocaine is contraindicated in pregnancy due to potential risks to the fetus, which may include adverse effects on fetal development. Given these concerns, pregnant patients should use this product only if clearly needed and after thorough discussion with their healthcare provider.

Dosage adjustments may be necessary for pregnant patients, and it is advised to consult a healthcare provider before use to ensure appropriate management and minimize potential risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 have not been defined.

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 and management strategies.

Healthcare providers should ensure that patients are monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this 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 a controlled temperature range of 68° to 77°F (20° to 25°C) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

Additional Clinical Information

The product is administered topically, with instructions for patients to spray an even layer of burn spray over the cleaned affected area. This application should not exceed 3-4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 2.0% Lidocaine Burn, 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 2.0% Lidocaine Burn, 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.