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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
58228-6210
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. If you’re experiencing discomfort from these types of skin injuries, this drug can help soothe the pain and make you feel more comfortable. It’s important to use it as directed to effectively manage your symptoms.

Uses

If you're dealing with minor burns or sunburn, this medication can help provide temporary relief from the pain associated with these skin injuries. It's designed to soothe discomfort, allowing you to feel more comfortable while your skin heals.

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

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 safety and proper care for younger children. Always follow your healthcare provider's advice regarding dosage and application.

What to Avoid

It's important to use this medication safely to avoid any 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 ensure your safety and the effectiveness of the treatment. Always follow these guidelines to protect your health.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should only apply it externally and avoid using it on wounds or damaged skin, as well as in large amounts, especially on raw or blistered areas. Be careful to keep it away from your eyes and avoid tightly bandaging the area after application.

If your condition worsens, if symptoms last more than 7 days, or if symptoms improve and then return within a few days, stop using the product and consult a doctor. Additionally, keep it out of reach of children, and if swallowed, seek medical help 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 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, 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

The safety of this product during pregnancy has not been established, which means that it may not be safe for you or your developing baby. It is not recommended for use in pregnant women due to potential risks to the fetus (the unborn baby).

If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before using this product. They can help you understand the risks and make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it’s important to consult your doctor before using this product. Currently, there is no specific information available about whether this product can pass into breast milk or what risks it may pose to your baby. Your healthcare provider can help you weigh the benefits and any potential concerns to ensure the safety of both you and your infant.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 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 kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 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 a controlled room temperature between 20º-25ºC (68º-77ºF). This temperature range helps maintain the product's effectiveness. Additionally, always check the packaging for a tamper-evident seal before use. If the 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 the drug used for?

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

How should I apply the drug?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for this drug?

You should not use this drug on wounds or damaged skin, or in large quantities over raw surfaces or blistered areas.

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 then occur again within a few days.

Is this drug safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and it is not recommended for use in pregnant women due to potential risks to the fetus.

What precautions should I take when using this product?

Avoid contact with the eyes and do not bandage tightly when using this product.

What should I do if the product is swallowed?

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

How should I store this drug?

Store at controlled room temperature between 20º-25ºC (68º-77ºF) and do not use if the seal is damaged.

Packaging Info

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

Packaging configurations for Burn Ease.
Details

Drug Information (PDF)

This file contains official product information for Burn Ease, 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 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 contraindicated to prevent exacerbation of the condition and to minimize the risk of systemic absorption.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product on wounds or damaged skin, as well as in large quantities, particularly over raw surfaces or blistered areas.

While utilizing this product, it is crucial to avoid contact with the eyes. Additionally, patients should be instructed not to apply tight bandages over the treated area to prevent complications.

Patients should be advised to discontinue use and consult a healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

To ensure safety, this product must 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.

Side Effects

Patients using this product may experience adverse reactions that necessitate caution and appropriate management. The product is intended for external use only and should not be applied to wounds or damaged skin. It is advised to avoid using the product in large quantities, particularly over raw surfaces or blistered areas.

While using this product, patients should take care to 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 resolve and then recur within a few days, it is recommended that they stop use and consult a healthcare professional.

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 patient should contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Burn Ease.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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.

Pregnancy

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

Lactation

Lactating mothers are advised to consult a doctor prior to using this product. Currently, there is no specific information available regarding the potential for excretion of this product 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 absence of guidance 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 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 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 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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay. This information is vital for ensuring prompt and appropriate care in case of an emergency.

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 a controlled room temperature between 20ºC and 25ºC (68ºF to 77ºF). Proper adherence to these storage conditions is 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 Burn Ease, 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, 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.