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Xeroburn Burn Gel

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Active ingredient
Lidocaine Hydrochloride 2 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 2017
Label revision date
March 13, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2 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 2017
Label revision date
March 13, 2025
Manufacturer
Dynarex Corporation
Registration number
M017
NDC root
67777-129
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

XeroBurn Burn Gel is a topical product designed to provide temporary relief from pain associated with minor burns and sunburn. It offers a cooling sensation that helps soothe the affected area, making it easier for you to manage discomfort from these skin injuries. This gel is specifically formulated to help you feel more comfortable while your skin heals.

Uses

If you're dealing with minor burns or sunburn, this product can help provide temporary relief from the pain associated with these skin injuries. It works by offering a cooling sensation that helps soothe discomfort, making it easier for you to manage your symptoms.

You can rely on this product for quick pain relief, allowing you to feel more comfortable while your skin heals. Remember, it's designed specifically for minor burns and sunburns, so it's best to use it for those purposes.

Dosage and Administration

You can use this medication to help with your skin condition by applying it directly to the affected area. For adults and children who are 2 years old and older, you should apply it no more than 3 to 4 times a day. If your child is under 2 years old, it’s important to consult a doctor before using the medication.

Make sure to follow these guidelines closely to ensure the best results. Remember, applying the medication too frequently may not provide additional benefits and could lead to irritation. Always wash your hands before and after applying the medication to keep the area clean and avoid spreading any infection.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid using large quantities, especially on raw surfaces or blistered areas, to prevent adverse effects.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider for more information.

Side Effects

When using this product, it's important to apply it only to the skin and avoid using it on wounds or damaged areas. Be cautious not to use large amounts, especially on raw or blistered skin, and keep it away from your eyes. If your condition worsens, if symptoms last longer than seven days, or if symptoms improve and then return within a few days, stop using the product and consult a doctor.

Additionally, keep this product out of reach of children. If swallowed, seek medical assistance 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 applying it to wounds or damaged skin, and do not use it in large amounts, especially on raw or blistered areas. While using this product, be careful not to get it in your eyes, and avoid wrapping the area tightly with a bandage.

If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then 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 immediately or contact 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 on 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 XEROBURN BURN GEL during pregnancy, there is currently no information available about its safety, recommended dosage, 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 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 or treatment.

Lactation Use

If you are breastfeeding, you can use XeroBurn Burn Gel without specific warnings or recommendations. Currently, there is no information available about whether this product is passed into breast milk or if it poses any risk to your nursing infant. As always, if you have concerns or questions about using any product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before using the medication. This ensures their safety and proper care. Always prioritize your child's health by following these recommendations.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 15º-30ºC (59º-86ºF). This temperature range helps maintain the product's effectiveness. Additionally, always check the seal before use; if the tamper-evident seal is damaged, do not use the product, as this could compromise its safety and integrity.

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

Additional Information

No further information is available.

FAQ

What is XeroBurn Burn Gel used for?

XeroBurn Burn Gel is used for the temporary relief of pain associated with minor burns and sunburn, providing cooling pain relief.

How should I apply XeroBurn Burn Gel?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. Consult a doctor for children under 2 years of age.

Are there any warnings I should be aware of?

Yes, XeroBurn Burn Gel is for external use only. Avoid contact with the eyes and do not bandage tightly.

What should I do if my condition worsens?

Stop using the product and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

What should I do if XeroBurn Burn Gel is swallowed?

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

Can I use XeroBurn Burn Gel on wounds or damaged skin?

No, do not use XeroBurn Burn Gel on wounds or damaged skin, or in large quantities over raw surfaces or blistered areas.

Is there any information about using XeroBurn Burn Gel during pregnancy or while nursing?

There is no specific information provided regarding the use of XeroBurn Burn Gel during pregnancy or in nursing mothers.

How should I store XeroBurn Burn Gel?

Store XeroBurn Burn Gel at room temperature between 15º-30ºC (59º-86ºF) and do not use if the seal is damaged.

Packaging Info

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

Packaging configurations for Xeroburn Burn Gel.
Details

Drug Information (PDF)

This file contains official product information for Xeroburn Burn Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

XeroBurn Burn Gel is a topical formulation designed for the management of burn injuries. The gel is characterized by its clear appearance and is intended for application to affected areas of the skin. The specific composition and formulation details, including active and inactive ingredients, contribute to its efficacy in providing relief and promoting healing in burn cases.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns and sunburn. It provides cooling pain relief to alleviate discomfort in affected areas.

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 dosage is to apply the medication to the affected area no 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 healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated on wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, application in large quantities, particularly over raw surfaces or blistered areas, is not recommended as it may exacerbate skin irritation or lead to further complications.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in large quantities, particularly over raw surfaces or blistered areas.

When utilizing this product, it is imperative to avoid contact with the eyes. Additionally, bandaging should not be applied tightly to the treated area to prevent complications.

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

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product may experience adverse reactions, particularly if the product is not used as directed. It is important to note that this product is for external use only and should not be applied to wounds or damaged skin. Additionally, the application of large quantities, especially over raw surfaces or blistered areas, is contraindicated.

While using this product, patients should avoid contact with the eyes and should not bandage the area tightly. If a patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to stop use and consult a healthcare professional.

Furthermore, this product should be kept out of reach of children. 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.

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 the current information.

Packaging & NDC

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

Packaging configurations for Xeroburn Burn Gel.
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 children under 2 years of age, it is advised to consult a doctor prior to 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 XEROBURN BURN 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 and weigh the potential risks and benefits. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider before using this product.

Lactation

There are no specific warnings or recommendations regarding the use of XeroBurn Burn Gel in lactating mothers. Additionally, there is no information available concerning the potential for excretion of the product 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 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on appropriate actions to take.

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 overdose-related complications.

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 for XEROBURN BURN GEL.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients to avoid contact with the eyes to prevent irritation or injury.

Healthcare providers should emphasize that patients should not bandage the affected area tightly, as this may exacerbate the condition. Patients must be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be advised to stop using the product and seek medical advice if symptoms resolve but then recur within a few days.

Patients should be cautioned against using the product on wounds or damaged skin, as this could lead to further complications. Furthermore, it is essential to inform patients to avoid using the product in large quantities, especially over raw surfaces or blistered areas, to minimize the risk of adverse effects.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the seal before use; do not utilize the product if the seal is damaged.

For optimal storage, the product should be maintained at room temperature, within the range of 15º to 30ºC (59º to 86ºF). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Xeroburn Burn Gel, 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 Xeroburn Burn Gel, 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

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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.