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Burn Jel

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Active ingredient
Lidocaine Hydrochloride 2 g/100 mL
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 2010
Label revision date
January 6, 2025
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
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 2010
Label revision date
January 6, 2025
Manufacturer
Water-Jel Technologies
Registration number
M017
NDC root
59898-200
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (7 NDCs)
Packaging & NDC Codes (7)

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

You may find that this medication provides temporary relief from pain associated with minor burns. It is designed to help ease discomfort, allowing you to manage pain effectively while your skin heals. If you experience minor burns, this medication can be a supportive option to consider for alleviating your pain.

Uses

If you’re dealing with minor burns, this medication can help provide temporary relief from the pain associated with your injury. It’s designed specifically for this purpose, allowing you to manage discomfort while your skin heals.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects) associated with this medication. This makes it a safer option for those in need of pain relief from minor burns.

Dosage and Administration

When using this medication, you should apply it to the affected area of your skin. For adults and children who are 2 years old and older, you can do this up to 3 to 4 times each day. Make sure to spread a thick, even layer over the area that needs treatment.

If you have a child who is under 2 years of age, it’s important to consult a doctor before using this medication. They can provide guidance on the best course of action for your child's specific needs.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should avoid applying it to large areas of your body, as this can increase the risk of side effects. Additionally, do not use it on broken, blistered, or oozing skin, as this can lead to complications or worsen your condition. Always follow these guidelines to help protect your health.

Side Effects

This product is intended for external use only, so please avoid applying it to large areas of your body or on broken, blistered, or oozing skin. While using the product, be careful to keep it away from your eyes.

If you notice that your condition worsens, if symptoms last longer than 7 days, or if the issue clears up and then comes back within a few days, stop using the product and consult a doctor. 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 intended for external use only, so please avoid applying it to large areas of your body or on any broken, blistered, or oozing skin. While using the product, be careful not to let it come into contact with your eyes.

If your condition worsens, symptoms last longer than 7 days, or if the issue clears up and then returns 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 too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

The safety of lidocaine hydrochloride gel during pregnancy has not been established, which means that it may not be safe for you or your developing baby. Because of potential risks to the fetus, it is not recommended to use this product while you are pregnant.

If you are pregnant or planning to become pregnant, it’s important to consult your healthcare provider before using this gel. They can help you understand the risks and determine the best options for your health and the health of 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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you have a child who is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important to consult a doctor before using this medication. Always ensure you follow these guidelines to keep your child safe and healthy.

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

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have 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 health situation. They can help determine the best course of action based on your kidney function and overall 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 should be used if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically to the affected area, no more than 3 to 4 times a day, if you are an adult or a child aged 2 years and older. It's important to monitor your condition closely. If your symptoms worsen, persist for more than 7 days, or if the condition clears up and then returns within a few days, stop using the product and consult a doctor.

Keep this medication out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately. If you experience any serious side effects, you can report them by calling 800-275-3433.

FAQ

What is the primary use of this drug?

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

How should I apply this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily, spreading a thick, even layer over the skin.

What should I do if I am pregnant?

The use of this product is not recommended during pregnancy due to potential risks to the fetus. Consult a healthcare provider before use.

Can I use this drug on broken or blistered skin?

No, you should not use this drug on broken, blistered, or oozing skin.

What should I do if symptoms persist?

Stop use and ask a doctor if symptoms persist for more than 7 days or if the condition worsens.

Is this drug safe for children?

Children under 2 years of age should consult a doctor before use.

What precautions should I take when using this product?

Avoid contact with eyes and do not use on large areas of the body.

What should I do if the product is swallowed?

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

How should I store this drug?

Store at room temperature.

Packaging Info

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

Packaging configurations for Burn Jel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the code 51945-4 and is associated with the effective date of May 26, 2020. It is presented in a principal display panel format, which includes multiple images for reference. The first image, labeled as the Principal Display Label, is in JPEG format and is referenced as BJUD.00.004.jpg. The second image, labeled BJ2RD, is also in JPEG format and is referenced as BJ2RD.00.018_Page_1.jpg. The third image, labeled BJ4RD, is similarly in JPEG format and is referenced as BJ4RD.00.018.jpg.

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 spread a thick, even layer of the product over the affected area. This should be done no more than 3 to 4 times daily.

In the case of children under 2 years of age, it is advised to consult a healthcare professional before use.

Contraindications

Use is contraindicated on large areas of the body due to the potential for systemic absorption and adverse effects. Additionally, application is contraindicated on broken, blistered, or oozing skin to prevent further irritation and complications.

Warnings and Precautions

For external use only. This product is contraindicated for application on large areas of the body, as well as on broken, blistered, or oozing skin.

When utilizing this product, it is imperative to avoid contact with the eyes to prevent irritation or injury.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: worsening of conditions, persistence of symptoms beyond 7 days, or recurrence of the condition shortly after it has cleared.

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

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on large areas of the body, as well as on broken, blistered, or oozing skin. During application, it is important to avoid contact with the eyes.

In the event that conditions worsen or symptoms persist for more than 7 days, patients are advised to discontinue use and consult a doctor. Additionally, if the condition clears up and then recurs within a few days, medical advice should be sought.

This product should be kept out of the reach of children. If swallowed, it is imperative 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 are no known interactions between this medication and laboratory tests. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Burn Jel.
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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine hydrochloride gel during pregnancy has not been established. The use of this product is not recommended during pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Serious adverse reactions to this product have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse reactions to the designated contact number, 800-275-3433.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to large areas of the body, nor should it be used on broken, blistered, or oozing skin.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be made aware that they should stop using the product and seek medical advice if the condition improves but then recurs within a few days.

While using this product, patients must be cautioned to avoid contact with their eyes to prevent irritation or injury.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered topically to adults and children aged 2 years and older, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if the condition resolves and recurs within a few days.

Additionally, it is important to keep the product out of the reach of children. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. For reporting serious adverse reactions, patients can call 800-275-3433.

Drug Information (PDF)

This file contains official product information for Burn Jel, 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 Jel, 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.