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Burn

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Active ingredient
Lidocaine Hydrochloride 2 mg/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 2025
Label revision date
August 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2 mg/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 2025
Label revision date
August 15, 2025
Manufacturer
HART Health
Registration number
M017
NDC root
50332-0209
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

If you are looking for relief from the discomfort caused by minor burns, this medication can help provide temporary pain relief. It is specifically designed to ease the pain associated with these types of injuries, allowing you to feel more comfortable as you heal.

Uses

You can use this medication for temporary relief from the pain associated with minor burns. It helps soothe discomfort and makes it easier for you to manage your daily activities while healing. There are no known risks of causing birth defects (teratogenic effects) or other non-birth defect related issues with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area thoroughly. Once it's clean, you can apply the medication directly to the area that needs treatment. You should do this no more than 3 to 4 times a day. If the area is dry, you may cover it with a sterile bandage (a clean dressing that helps protect the area).

If you are considering using this medication for a child under 2 years of age, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this product safely to avoid potential issues. You should never apply it in or near your eyes, over large areas of your body, or in large amounts, especially on raw or blistered skin. Additionally, avoid using it on serious burns, animal bites, or deep and puncture wounds. If you need to use it for more than 7 days, make sure to consult your doctor first. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

You should be aware that this product is for external use only. It's important to avoid using it near your eyes, on large areas of your body, or in large amounts, especially on raw or blistered skin, serious burns, animal bites, or deep wounds. If your condition does not improve within 7 days, worsens, or if symptoms clear up and then return shortly after, you should stop using the product and consult a 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.

Warnings and Precautions

This product is for external use only, so please avoid using it in or near your eyes, on large areas of your body, or in large amounts, especially on raw or blistered skin. It should not be applied to serious burns, animal bites, or deep puncture wounds, and you should not use it for more than 7 days unless your doctor advises otherwise. If you experience serious burns, seek medical attention immediately.

If your condition does not improve after 7 days, worsens, or if symptoms clear up and then return within a few days, stop using the product and contact your doctor. In case of accidental ingestion, seek emergency medical help or call a Poison Control Center at 1-800-222-1222 right away.

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

Currently, there is no information available about the use of BURN - lidocaine spray during pregnancy. This means that if you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best options for your situation. Always prioritize your health and the health of your baby when considering any medication.

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

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 the medication to the affected area, but be sure not to exceed 3 to 4 applications in a 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 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 to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

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° to 77°F (20-25°C). This temperature range helps maintain the integrity of the device.

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

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for temporary pain relief of minor burns.

How should I apply this drug?

Clean the affected area and apply it not more than 3 to 4 times daily. It may be covered with a sterile bandage when dry.

What should I do if I have a child under 2 years of age?

You should ask a doctor before using this drug on children under 2 years of age.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What precautions should I take when using this drug?

Do not use it in or near the eyes, over large portions of the body, on serious burns, or for longer than 7 days unless directed by a doctor.

What should I do if my condition worsens or lasts more than 7 days?

Stop using the drug and ask a doctor if your condition lasts for more than 7 days or worsens.

What should I do if the drug is swallowed?

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

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this drug?

Store the drug at 68° to 77°F (20-25°C).

Packaging Info

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

Packaging configurations for Burn.
Details

Drug Information (PDF)

This file contains official product information for 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.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned prior to application. The medication is to be applied to the affected area no more than 3 to 4 times daily. Once the application has dried, the area may be covered with a sterile bandage if desired.

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

Contraindications

Use is contraindicated in the following situations:

  • Application in or near the eyes is prohibited due to the potential for irritation or injury.

  • Avoid use over large areas of the body to prevent systemic absorption and potential adverse effects.

  • Do not apply in large quantities, especially on raw surfaces or blistered areas, as this may exacerbate irritation or lead to systemic effects.

  • The product should not be used on serious burns, as this may interfere with healing and increase the risk of infection.

  • Prolonged use beyond 7 days is contraindicated unless directed by a healthcare professional to avoid potential complications.

  • Application on animal bites is not recommended due to the risk of infection and inadequate healing.

  • The product should not be used on deep or puncture wounds, as this may hinder proper wound management and increase the risk of complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to seek immediate medical attention for serious burns.

General precautions must be observed when using this product. It should not be applied in or near the eyes, over large areas of the body, or in excessive quantities, particularly on raw surfaces or blistered areas. The product is contraindicated for use on serious burns, animal bites, or deep or puncture wounds. Additionally, it should not be used for longer than 7 days unless directed by a healthcare provider.

Patients should be instructed to discontinue use and consult a physician if the condition persists for more than 7 days, worsens, or if symptoms resolve and then recur within a few days.

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 should be aware that the product is for external use only. Serious burns require immediate medical attention. It is contraindicated for use in or near the eyes, over large areas of the body, in large quantities—especially on raw surfaces or blistered areas, on serious burns, on animal bites, or on deep or puncture wounds. Additionally, the product should not be used for longer than 7 days unless directed by a healthcare professional.

Patients are advised to discontinue use and consult a doctor if the condition persists for more than 7 days, worsens, or if symptoms resolve and then recur within a few days.

It is crucial to keep this 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 at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 Burn (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn.
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 not more than 3 to 4 times daily.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of BURN - lidocaine spray during pregnancy. As such, the potential risks to pregnant patients and fetal outcomes remain undetermined. Healthcare professionals should exercise caution when considering the use of this medication in women of childbearing potential and weigh the benefits against any potential risks. It is advisable to discuss alternative treatment options with patients who are pregnant or planning to become pregnant.

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 clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

Symptoms of overdose may vary depending on the substance involved and the amount ingested. It is essential for healthcare providers to assess the patient's condition thoroughly and monitor for any signs of toxicity.

Management of an overdose should be guided by the specific circumstances of the case, including the substance involved and the severity of symptoms. Supportive care and symptomatic treatment may be necessary, and healthcare professionals should follow established protocols for overdose management.

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 the medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if the medication is swallowed, they should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance. This information is crucial for ensuring patient safety and prompt action in case of an emergency.

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 temperature range of 68° to 77°F (20-25°C) to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.