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Burn Ease Cooling

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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 2025
Label revision date
September 17, 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 2025
Label revision date
September 17, 2025
Manufacturer
ProStat First Aid LLC
Registration number
M017
NDC root
58228-2893
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

If you are experiencing minor burns, there is a medication designed to provide temporary pain relief. This drug works specifically to alleviate the discomfort associated with these types of injuries, helping you feel more comfortable as you heal. While the exact mechanism of action isn't detailed, its primary purpose is to ease the pain you may be feeling from minor burns.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain. It’s designed to help ease the discomfort you may experience while your skin heals. Remember, this is specifically for minor burns, so if your injury is more severe, it’s important to seek medical attention.

Dosage and Administration

To use the burn gel effectively, start by cleaning the affected area thoroughly. Once it's clean, apply an even layer of the gel directly onto the burn. You can do this up to 3 to 4 times a day, ensuring that you don’t exceed this frequency for the best results.

It's important to note that this burn gel is not recommended for children under 12 years of age, so please avoid using it on younger individuals. Always follow these guidelines to help promote healing and comfort for your skin.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it in large amounts, especially on raw or blistered skin, as this could 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 associated with this product, following these guidelines will help ensure your safety and well-being.

Side Effects

You should only use this product externally and avoid applying it in large amounts, especially on raw or blistered skin. Be careful not to get it near your eyes; if that happens, rinse your eyes thoroughly with water. If your condition worsens, lasts more than seven days, or clears up and then returns, stop using the product and consult a doctor.

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.

Warnings and Precautions

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

If your condition worsens, does not improve after 7 days, or clears up and then returns, stop using the product and consult your doctor. Additionally, if you accidentally swallow any of the product, 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 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

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

It's important to know that this medication should not be used in children under 12 years of age. If you have younger children, make sure to keep the medication out of their reach to prevent accidental ingestion.

In the event that a child swallows this medication, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your child's safety is a top priority, so always follow these guidelines closely.

Geriatric Use

When considering medication for older adults, it's important to note that this particular drug is not recommended for children under 12 years of age. If you are caring for an older adult, ensure that any medications prescribed are appropriate for their age and health status. Always consult with a healthcare professional to discuss any concerns or questions about medication use in older individuals.

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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments 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 (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 monitor your condition and make any necessary adjustments to your treatment plan.

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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). It's important to keep the product in its tamper-evident sealed packets, which help ensure that it has not been compromised. If you notice any opened or torn packets, do not use them, as this could affect the product's safety and performance.

Always handle the product with care, following these guidelines to maintain its integrity and your safety. Proper storage and handling are key to ensuring that you get the best results from your product.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug provides temporary pain relief associated with minor burns.

How should I apply the burn gel?

Apply an even layer of burn gel over the cleaned affected area no more than 3-4 times daily.

Is this drug safe for children?

This drug should not be used on children under 12 years of age.

What should I do if I accidentally get the gel in my eyes?

If the gel gets in your eyes, rinse thoroughly with water.

What should I do if the condition worsens or persists?

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

What should I do if the gel is swallowed?

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

What are the storage conditions for this drug?

Store the drug at 68-77°F (20-25°C) and use tamper evident sealed packets.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Can I use this drug on raw or blistered areas?

Do not use this drug in large quantities, particularly over raw or blistered areas.

Packaging Info

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

Packaging configurations for Burn Ease Cooling.
Details

Drug Information (PDF)

This file contains official product information for Burn Ease Cooling, 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. It is intended for use in patients experiencing discomfort due to such injuries.

Dosage and Administration

Healthcare professionals are advised to apply an even layer of burn gel over the cleaned affected area. This application should not exceed 3 to 4 times daily.

It is important to note that this product is contraindicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities, particularly over raw or blistered areas, is not recommended 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 over raw or blistered areas. It is imperative 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 advice if the condition worsens or persists for more than 7 days, or if the condition appears to improve and then returns.

In cases of ingestion, immediate medical assistance is required. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help 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 returns.

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 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 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 Cooling (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn Ease Cooling.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients should be considered when prescribing this medication, particularly those aged 65 years and older. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should exercise caution when prescribing to geriatric patients, as age-related physiological changes may affect drug metabolism and response. Monitoring for efficacy and safety is recommended, and dose adjustments may be necessary based on individual patient factors.

Pregnancy

There is no specific information regarding the use of this medication 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. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay. It is recommended to reach out to a Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management protocols 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 these contexts.

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 at 1-800-222-1222 if the product is swallowed.

Patients should be cautioned against using the product in large quantities, especially on raw or blistered areas, to avoid potential adverse effects.

Instruct patients to take care to avoid contact with the eyes. If contact occurs, they should rinse the eyes thoroughly with water to mitigate any irritation.

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 the condition clears up and then returns.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Burn Ease Cooling, 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 Cooling, 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.