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Lidocaine hydrochloride

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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 2024
Label revision date
December 15, 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 2024
Label revision date
December 15, 2025
Manufacturer
Front Line Safety
Registration number
M017
NDC root
58228-6232
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

This medication is designed to provide temporary relief from pain associated with minor burns and sunburn. It helps soothe discomfort, allowing you to feel more comfortable while your skin heals. If you’re dealing with the pain of a minor burn or sunburn, this product may be a helpful option for you.

Uses

If you're looking for temporary relief from pain caused by minor burns or sunburn, this product may be suitable for you. It is specifically designed to help ease the discomfort associated with these types of skin injuries.

You can use it to soothe the affected areas, allowing for a more comfortable recovery. Remember, while it can provide relief, it's important to follow any additional care instructions for burns and sunburns to ensure proper healing.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure that it is safe and appropriate for their specific needs. Always follow your healthcare provider's advice for the best care.

What to Avoid

It's important to use this product safely. You should avoid applying it to wounds or any damaged skin, as this can lead to irritation or other complications. Additionally, refrain from using large amounts, especially on raw surfaces or blistered areas, to prevent adverse effects. Always prioritize your health and well-being by following these guidelines.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to wounds or damaged skin, and do not use large amounts, especially on raw or blistered areas. Be careful to keep it away from 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 a doctor. Additionally, 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 intended for external use only, so please avoid applying it to wounds or damaged skin. It's important not to use large amounts, especially on raw or blistered areas. While using this product, be careful to keep it away from 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, if the product is swallowed, seek emergency 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 signs 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

There is currently no specific information available about the use of this medication during pregnancy. Importantly, there are no stated risks or contraindications for the fetus, meaning that no known dangers have been identified. Additionally, there are no recommended changes to the dosage for pregnant individuals, nor are there any special precautions to consider when using this medication during pregnancy.

As always, it's essential to discuss any medications you are taking or considering with your healthcare provider, especially if you are pregnant or planning to become pregnant. They can provide personalized advice based on your health needs.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. Always consult with your healthcare provider if you have any questions or concerns 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 the medication 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 it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

While there is no specific information about the use of Burn Ease 3.5g gel in older adults, it's important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide guidance tailored to your individual health needs and any potential interactions with other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

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 may affect you 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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. 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 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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and disposal.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

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

How often can adults and children 2 years of age and older use this product?

You can apply it to the affected area not more than 3 to 4 times daily.

What should I do if my child is under 2 years of age?

If your child is under 2 years of age, you should consult a doctor before use.

Are there any contraindications for this drug?

No contraindications are specified for this drug.

What precautions should I take when using this product?

Avoid contact with the eyes and do not bandage tightly. Do not use on wounds or damaged skin.

What should I do if I accidentally swallow this product?

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

Is this drug safe to use during pregnancy?

No specific information is provided regarding the use of this product during pregnancy.

Can nursing mothers use this product?

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

What should I do if my condition worsens or symptoms persist?

You should stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

How should I store this product?

You should store it at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Burn Ease 3.5g. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn Ease 3.5g.
Details

Drug Information (PDF)

This file contains official product information for Burn Ease 3.5g, 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 and sunburn.

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 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, the application of 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. Caution is advised against the use of large quantities, particularly over raw surfaces or blistered areas, as this may exacerbate adverse effects.

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 instruct patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist beyond 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 (1-800-222-1222) should be contacted without delay.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not be applied to wounds or damaged skin. Caution should be exercised to avoid using large quantities, particularly over raw surfaces or blistered areas.

While using this product, patients should avoid contact with the eyes and refrain from bandaging the area tightly. If the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

Additionally, 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 (1-800-222-1222) should be contacted without delay.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Burn Ease 3.5g. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn Ease 3.5g.
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 Burn Ease 3.5g gel in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of geriatric patients prior to use, given the lack of established guidelines for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy. Currently, there are no statements indicating contraindications or risks to the fetus associated with its use in pregnant patients. Additionally, no dosage modifications are recommended for individuals who are pregnant, and no special precautions have been noted for the use of this medication in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert text. 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

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 use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients 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 not to apply the product on wounds or damaged skin, as this may lead to adverse effects.

Patients should be cautioned against using large quantities of the product, especially over raw surfaces or blistered areas, to prevent potential complications. They should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve and then recur within a few days.

While using the product, patients must be reminded to avoid contact with the eyes to prevent irritation or injury. Furthermore, it is essential to instruct patients not to bandage the area tightly when using the product, as this may affect its efficacy and safety.

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

No further data are available.

Drug Information (PDF)

This file contains official product information for Burn Ease 3.5g, 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 Ease 3.5g, 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.