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Lidocaine hydrochloride/Benzalkonium chloride

Last content change checked dailysee data sync status

Active ingredients
  • Lidocaine Hydrochloride 50 mg/10000 mg
  • Benzalkonium Chloride 13 mg/10000 mg
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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 ingredients
  • Lidocaine Hydrochloride 50 mg/10000 mg
  • Benzalkonium Chloride 13 mg/10000 mg
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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
58228-6244
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

FL-2044 is a medication designed to provide temporary relief from pain and itching caused by various skin issues. You can use it for conditions such as sunburn, minor burns, insect bites, minor skin irritations, cuts, and scrapes. This makes it a helpful option for soothing discomfort associated with these common skin problems.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. It is effective for soothing discomfort from sunburn, minor burns, insect bites, and minor skin irritations. Additionally, it can help alleviate pain and itching associated with cuts and scrapes.

This product is designed to provide quick relief, making it a handy option for treating everyday skin irritations.

Dosage and Administration

To use this product effectively, start by cleaning the affected area thoroughly. Once it's clean, apply a small amount of the product directly to the area you want to treat. You should do this 3 to 4 times each day for the best results. If you prefer, you can cover the area with a sterile bandage to protect it.

If you are using this product for a child under 2 years old, it's important to consult a doctor before applying it. This ensures that the treatment is safe and appropriate for their age.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should never apply it to your eyes or use it over large areas of your body. Additionally, avoid using it on deep puncture wounds, animal bites, or serious burns. Be cautious not to apply large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. Always follow these guidelines to ensure your safety and the effectiveness of the treatment.

Side Effects

You should be aware that this product is for external use only and should not be applied to your eyes, large areas of your body, deep puncture wounds, animal bites, or serious burns. It's important to avoid using it in large amounts, especially on raw or blistered skin. If your condition worsens, clears up and then comes back within a few days, or does not improve after a week, you should stop using the product and consult a doctor.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Additionally, keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or on large areas of your body. It should not be used on deep puncture wounds, animal bites, or serious burns, and you should refrain from using large amounts, especially on raw or blistered skin.

If your condition worsens, clears up and then comes back within a few days, or if it lasts longer than 7 days, stop using the product and contact your doctor. Additionally, if you accidentally swallow the product, seek emergency medical help immediately or call 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

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize open communication with your doctor to ensure the safety of both you and your baby.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

If you have a child under 2 years old, it's important to consult a doctor before using this product. For children aged 2 years and older, you can apply a small amount to the affected area 3 to 4 times a day after cleaning the area. If needed, you may cover it with a sterile bandage to protect the area. Always follow these guidelines to ensure safe and effective use for your child.

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. As you age, your body may process medications differently, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any adjustments are needed based on individual health conditions and ensure that the treatment is safe and effective for older adults. Always prioritize open communication with your healthcare team about any concerns or questions you may have.

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 should be used if you have hepatic impairment (liver issues).

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 you understand how to manage your treatment effectively.

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 safety and effectiveness of your product, store it in a cool, dry area with a temperature between 15º-25ºC (59º-77ºF). This helps maintain its quality. Each packet is tamper evident, meaning it has a seal that shows if it has been opened or altered. For your safety, do not use any packets that are opened or torn, as this could compromise the product. Always check the packaging before use to ensure it is intact.

Additional Information

No further information is available.

FAQ

What is FL-2044 used for?

FL-2044 is used for the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritations, cuts, and scrapes.

How should I use FL-2044?

For adults and children 2 years and over, clean the affected area and apply a small amount of the product 3 to 4 times daily. It may be covered with a sterile bandage.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health care professional before using FL-2044.

Are there any warnings associated with FL-2044?

Yes, FL-2044 is for external use only. Do not use it in the eyes, over large areas of the body, or on deep puncture wounds, animal bites, or serious burns.

What should I do if the condition worsens or persists?

Stop using FL-2044 and call a doctor if the condition gets worse, clears up and recurs within a few days, or persists for more than 7 days.

What should I do if FL-2044 is swallowed?

If FL-2044 is swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Is there any specific advice for children under 2 years?

Yes, consult a doctor before using FL-2044 on children under 2 years.

How should FL-2044 be stored?

Store FL-2044 in a cool, dry area at a temperature between 15º-25ºC (59º-77ºF).

Packaging Info

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

Packaging configurations for First Aid Burn Cream.
Details

Drug Information (PDF)

This file contains official product information for First Aid Burn Cream, 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 and itching associated with various dermatological conditions, including sunburn, minor burns, insect bites, minor skin irritations, cuts, and scrapes.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product should be applied to the area 3 to 4 times daily. If desired, the treated area may be covered with a sterile bandage to protect it.

For children under 2 years of age, it is recommended to consult a doctor before use.

Contraindications

The product is contraindicated for use in the following situations:

  • Application in the eyes is prohibited due to potential for irritation or damage.

  • Use over large areas of the body, on deep puncture wounds, animal bites, or serious burns is contraindicated to prevent adverse effects and complications.

  • Application in large quantities, especially over raw surfaces or blistered areas, is not recommended to avoid exacerbating skin irritation or injury.

Warnings and Precautions

The product is intended for external use only. It is imperative that healthcare professionals advise patients against using the product in or around the eyes. Additionally, the product should not be applied over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Caution should be exercised to avoid the application of large quantities, particularly on raw surfaces or blistered areas.

Patients should be instructed to discontinue use and seek medical attention if the condition worsens, if the condition resolves and then recurs within a few days, or if the condition persists for more than 7 days.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be advised 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 for use in the eyes, over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Additionally, it should not be applied in large quantities, particularly over raw surfaces or blistered areas.

Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if the condition clears up and recurs within a few days, or if the condition persists for more than 7 days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use.

The product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center at 1-800-222-1222.

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 First Aid Burn Cream. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for First Aid Burn Cream.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before using this product. For children aged 2 years and older, the recommended application involves cleaning the affected area and applying a small amount of the product 3 to 4 times daily. The treated area may be covered with a sterile bandage if desired.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. The potential risks and benefits should be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure appropriate management during pregnancy.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 overdose, 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 overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided 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 tamper-evident sealed packets, ensuring the integrity and safety of the contents. It is essential to store the product in a cool, dry area, maintaining a temperature range of 15º-25ºC (59º-77ºF). 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 First Aid Burn Cream, 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 First Aid Burn Cream, 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.