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Fl Burn Ease, 0.9g

Last content change checked dailysee data sync status

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
October 1, 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
October 1, 2025
Manufacturer
ProStat First Aid LLC
Registration number
M017
NDC root
58228-6212
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

You may be looking for a medication that provides temporary relief from pain associated with minor burns. This type of drug is designed to help soothe discomfort and promote a sense of well-being while your skin heals.

While the specific name of the drug isn't mentioned, its primary purpose is to alleviate the pain that can occur from minor burns, making it easier for you to manage your daily activities during recovery. If you have any further questions about its use or effectiveness, consider consulting a healthcare professional for personalized advice.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain associated with your injury. It’s designed to help ease discomfort, allowing you to feel more comfortable as you heal.

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

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, depending on your needs.

It's important to note that this burn gel is not recommended for children under 12 years of age, so make sure to keep it out of reach of younger kids. Following these guidelines will help ensure you get the best results from the treatment.

What to Avoid

It's important to follow specific guidelines when using this product to ensure your safety. You should never use any opened or torn packets, as this could compromise the product's effectiveness. Additionally, avoid applying it in large quantities, especially on raw or blistered areas of your skin. Be cautious not to use it near your eyes; if contact occurs, rinse your eyes thoroughly with water.

By adhering to these instructions, you can help prevent any potential issues and ensure a safer experience with the product.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid using any opened or torn packets, and do not apply it in large amounts, especially on raw or blistered skin. Be careful to keep it away from your eyes; if it accidentally gets in your eyes, rinse thoroughly with water.

If your condition worsens, persists for more than 7 days, or clears up and then returns, 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 for external use only, so please avoid using it on any open or torn packets. Be cautious not to apply it in large amounts, especially on raw or blistered skin, and keep it away from your eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult your doctor if your condition worsens, lasts more than 7 days, or clears up and then returns. If you accidentally swallow 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 know that the safety of lidocaine, a medication often used for pain relief, has not been established. There are potential risks to your fetus, which is why lidocaine is generally not recommended during pregnancy unless absolutely necessary. If your healthcare provider determines that the benefits outweigh the risks, they may suggest using it with caution.

Before using lidocaine, you should always consult your healthcare provider. They may need to adjust the dosage specifically for you, ensuring that both you and your baby remain safe. Open communication with your healthcare team is essential to make informed decisions about 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 it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to know that this medication should not be used in children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that are safe and appropriate for their age. Always prioritize your child's health and follow medical advice regarding their treatment.

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 specific concerns or questions regarding 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 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 in a cool, dry place at a temperature between 68-77°F (20-25°C). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to use it from the tamper-evident sealed packets, which provide an extra layer of safety by indicating whether the packaging has been opened or compromised. Always follow these guidelines to ensure proper use and safety.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for 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 swallow the gel?

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

Are there any contraindications for using this drug?

There are no specific contraindications listed, but do not use opened or torn packets.

Can I use this drug if I am pregnant?

The safety of this drug during pregnancy has not been established, and it should only be used if clearly needed.

What should I do if my condition worsens?

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

What precautions should I take when using this drug?

For external use only; do not use in large quantities, particularly over raw or blistered areas, and avoid contact with eyes.

What is the recommended storage temperature for this drug?

Store the drug at 68-77°F (20-25°C).

Packaging Info

Below are the non-prescription pack sizes of Fl Burn Ease, 0.9g (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fl Burn Ease, 0.9g.
Details

Drug Information (PDF)

This file contains official product information for Fl Burn Ease, 0.9g, 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 drug.

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

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 of this product is contraindicated in the following situations:

  • Opened or torn packets should not be used to ensure product integrity and efficacy.

  • Application in large quantities, especially over raw or blistered areas, is contraindicated due to the potential for adverse effects.

  • The product should not be applied near the eyes; in the event of contact, rinse thoroughly with water to mitigate irritation.

Warnings and Precautions

For external use only. It is imperative that the product is not applied to any opened or torn packets, nor should it be used in large quantities, especially over raw or blistered areas. Care should be taken 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 clear up and then returns.

In cases of ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated to use any opened or torn packets and should not be applied in large quantities, particularly over raw or blistered areas. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the affected area should be rinsed thoroughly with water.

Patients are advised 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, the product should be kept out of reach of children. In the case of 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 Fl Burn Ease, 0.9g (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Fl Burn Ease, 0.9g.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals should consider alternative treatments for pediatric patients who fall within this age range.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should assess the overall health status and comorbidities of geriatric patients, as these factors may influence the safety and efficacy of the treatment. Monitoring for potential adverse effects is recommended, given that elderly patients may have altered pharmacokinetics and pharmacodynamics.

Dosage adjustments may be necessary based on individual patient characteristics, including renal and hepatic function, which can be affected by age. Therefore, close observation and appropriate dose modifications are advised to ensure optimal therapeutic outcomes while minimizing risks.

Pregnancy

The safety of lidocaine during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. There may be associated risks when lidocaine is administered to pregnant women; therefore, it should only be used if clearly needed and if the benefits outweigh the risks.

Dosage adjustments may be necessary for pregnant patients, and it is advised that they consult a healthcare provider prior to use. Special precautions should be taken, and pregnant women are encouraged to discuss the use of this medication with their healthcare provider to ensure safety for both the mother and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion 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 the use of 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 available 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. 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 complications arising from the overdosage.

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 medication is swallowed. It is important for patients to understand the urgency of this action to ensure their safety and well-being.

Storage and Handling

The product is supplied in tamper-evident sealed packets, ensuring the integrity and safety of the contents. It is recommended to store the product at a temperature range of 68-77°F (20-25°C) to maintain optimal quality and efficacy. Proper storage conditions are essential to preserve the product's effectiveness and ensure patient safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Fl Burn Ease, 0.9g, 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 Fl Burn Ease, 0.9g, 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.