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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 2024
Label revision date
January 18, 2024
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 2024
Label revision date
January 18, 2024
Manufacturer
HART Health
Registration number
M017
NDC root
50332-0210
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’re looking for relief from the discomfort caused by minor burns, this medication can help provide temporary pain relief. It is specifically designed to soothe the pain associated with these types of injuries, allowing you to feel more comfortable as you heal.

Uses

If you’re dealing with minor burns, this medication can provide you with temporary relief from the pain. It’s designed specifically to help ease discomfort associated with these types of injuries, allowing you to feel more comfortable as you heal.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause harm to a developing fetus. Additionally, there are no reported nonteratogenic effects, which means it is generally safe in terms of other potential side effects.

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 to protect it.

If you are considering this medication for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for their use.

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. If you find that you need to use it for more than 7 days, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

It's important to use this product only on the skin and to avoid contact with your eyes. Do not apply it to large areas of your body, especially over raw or blistered skin, or on serious burns. If you experience serious burns, seek medical attention immediately. You should not use the product for more than 7 days unless your doctor advises you to do so.

If your condition worsens, lasts 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, and if swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid using it on your eyes, large areas of your body, or on serious burns. It’s important not to apply it in large amounts, especially on raw or blistered skin, and you should not use it for more than 7 days unless your doctor advises otherwise.

If your condition worsens, lasts longer than 7 days, or if symptoms improve and then return within a few days, stop using the product and contact your doctor. In case of serious burns, seek medical attention immediately.

If the product is swallowed, get emergency help right away by contacting 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

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to note that there is no specific information available about the use of BURN - lidocaine spray in nursing mothers. This means that the effects on breast milk and nursing infants have not been studied or documented.

As a precaution, you may want to consult your healthcare provider before using this spray to ensure it is safe for you and your baby. They can provide guidance based on your individual situation and help you make an informed decision.

Pediatric Use

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional advice before administering any medication.

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 wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking multiple 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 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 medication may not have tailored instructions for individuals with renal impairment (kidney issues).

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 specific situation and any other health considerations you may have.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have about your medications or tests.

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 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

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 if I am an adult or a child over 12?

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

What should I do if I am under 12 years old?

If you are under 12 years of age, you should ask a doctor before using this drug.

Are there any contraindications for using 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, in large quantities on raw surfaces or blistered areas, on serious burns, or 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 worsens or lasts for more than 7 days.

What should I do if I accidentally swallow this drug?

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

What are the storage conditions for this drug?

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

Is this drug safe to use during pregnancy?

No specific information regarding safety during pregnancy is provided, so consult a doctor.

Can I use this drug if I have liver or kidney problems?

There is no specific information regarding use in patients with liver or kidney problems, so consult a doctor.

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 relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and over, 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 12 years of age, it is recommended to consult a doctor before use.

Contraindications

The product is contraindicated for use in the following situations:

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

  • Use over large areas of the body is not recommended, as it may lead to systemic absorption and adverse effects.

  • Application in large quantities, particularly on raw surfaces or blistered areas, is contraindicated to prevent exacerbation of skin conditions or systemic toxicity.

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

  • Prolonged use beyond 7 days is contraindicated unless directed by a healthcare professional, to avoid potential complications associated with extended exposure.

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 and 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 worsens, persists for more than 7 days, 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—and on serious burns. 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 their condition worsens, persists for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, it is crucial to keep the product out of reach of children. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for BURN - lidocaine spray. Therefore, healthcare professionals should exercise caution when considering the use of this medication in lactating mothers. The potential effects on breastfed infants have not been established, and the absence of data necessitates careful evaluation of the risks and benefits before administration.

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 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 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. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 emphasize the potential risks associated with swallowing the medication. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for further assistance.

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.