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Burn

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 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 2022
Label revision date
January 15, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 20 mg/1 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 2022
Label revision date
January 15, 2024
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-048
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

Burn Gel is a topical treatment designed to provide temporary pain relief for minor burns. It helps soothe the affected area, making it more comfortable as it heals. If you experience a minor burn, using Burn Gel can help alleviate discomfort and support your recovery.

Uses

You can use this medication for temporary relief from pain caused by minor burns. It helps soothe discomfort and makes it easier for you to manage your daily activities while healing.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause birth defects. It is designed to provide effective pain relief without additional risks.

Dosage and Administration

You can use this medication for treating affected areas on your skin if you are an adult or a child aged 2 years and older. Simply apply it to the affected area, but make sure not to do this more than four times a day.

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it in large amounts, especially on raw or blistered skin, as this can lead to irritation or other complications. Additionally, be careful not to use it near your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water to prevent discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always follow the usage instructions carefully to ensure your safety and well-being.

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 keep it away from your eyes—if contact occurs, rinse thoroughly with water.

You should stop using the product and consult your doctor if your condition worsens, does not improve after 7 days, or if it clears up and then returns within a few days. Additionally, keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered spots. Be careful not to get it near your eyes; if it does come into contact with them, rinse thoroughly with water.

If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication in excess, it’s important to seek medical help immediately. You can contact a Poison Control Center for guidance on what to do next.

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 get help if you suspect an overdose has occurred. Your safety is the top priority, so don’t hesitate to reach out for assistance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of lidocaine hydrochloride gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been clearly established.

Before using this gel, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during pregnancy.

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. 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, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to four times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always prioritize your child's safety and seek professional advice if you're unsure.

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 considering potential changes in health or how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs. Always keep them informed about any other medications or health conditions 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 standard recommendations for medication use may apply to you, but it’s always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.

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, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard any unused portion to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

You should apply this medication topically to the affected area, and it can be used by adults and children aged 2 years and older, up to four times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Burn Gel used for?

Burn Gel is used for temporary pain relief for minor burns.

Who can use Burn Gel?

Adults and children 2 years and older can use Burn Gel, applying it to the affected area no more than 4 times daily. Children under 2 years old should not use it and should consult a doctor.

Are there any contraindications for using Burn Gel?

No specific contraindications are mentioned for Burn Gel.

What should I do if my condition worsens while using Burn Gel?

You should stop using Burn Gel and ask a doctor if your condition worsens or persists for more than 7 days, or if it clears up and occurs again within a few days.

Is Burn Gel safe to use during pregnancy?

The provided text does not include specific information regarding the use of Burn Gel during pregnancy.

Can nursing mothers use Burn Gel?

There are no specific warnings or recommendations regarding the use of Burn Gel in nursing mothers.

How should I store Burn Gel?

Store Burn Gel at room temperature, protect it from light, do not freeze, and discard it after opening.

What should I do if I accidentally get Burn Gel in my eyes?

If Burn Gel gets in your eyes, rinse thoroughly with water.

What should I do if Burn Gel is swallowed?

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

Is Burn Gel a controlled substance?

No, there are no controlled substance classifications or details specified for Burn Gel.

Packaging Info

Below are the non-prescription pack sizes of Burn (lidocaine hydrochloride). 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

Burn Gel is a topical formulation designed for the management of burn injuries. The product is presented in a pouch, as indicated by the observation media, which is an image of the pouch label. The effective time for this formulation is noted as November 4, 2022.

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 2 years and older, the recommended application is to the affected area not more than four 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, the product should not be used without consulting a healthcare professional.

Contraindications

The product should not be applied in large quantities, particularly over raw or blistered areas, due to the potential for increased irritation or adverse effects. Additionally, application near the eyes is contraindicated; in the event of contact, the area should be rinsed thoroughly with water to mitigate any potential harm.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially on raw or blistered areas. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the affected area should be rinsed thoroughly with water.

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

It is imperative 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 should be made 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.

Participants are instructed to discontinue use and consult a healthcare professional if their condition worsens or persists for more than 7 days, or if the condition clears up and then recurs within a few days.

Additionally, it is crucial to keep the product out of reach of children. In cases where the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

No specific drug interactions have been identified in the available data. 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 hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to four times daily. For children under 2 years of age, the use of this medication is not recommended, and consultation with a healthcare professional is advised.

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 specific information available regarding the use of lidocaine hydrochloride gel 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 the absence of established safety profiles for this drug in pregnant individuals. Women of childbearing potential should be counseled on the unknown effects of lidocaine hydrochloride gel during pregnancy.

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 renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 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. Healthcare professionals are advised to seek medical help or contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved. It is essential for healthcare providers to assess the patient’s condition thoroughly and monitor for any adverse effects that may arise.

Management of overdosage should be guided by the clinical presentation and the specific substance involved. Supportive care and symptomatic treatment are often necessary. In cases of ingestion, activated charcoal may be considered if appropriate and within the recommended time frame. Continuous monitoring of vital signs and supportive measures should be implemented as needed.

Prompt recognition and intervention are critical in mitigating the potential consequences of an overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 if the product is swallowed. It is important to instruct patients not to use the product in large quantities, especially on raw or blistered areas, to avoid potential complications.

Patients should be cautioned against using the product near the eyes. In the event of contact with the eyes, they should rinse thoroughly with water to mitigate any adverse effects.

Additionally, healthcare providers should inform patients 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. This guidance is essential for ensuring patient safety and effective management of their condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to four times daily for adults and children aged 2 years and older. For children under 2 years, 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 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.