ADD CONDITION

items per page

Lidocaine hydrochloride/Benzalkonium chloride

Last content change checked dailysee data sync status

Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
December 15, 2025
Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
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
Marketed in the U.S.
Since 2023
Label revision date
December 15, 2025
Manufacturer
ProStat First Aid LLC
Registration number
M017
NDC root
58228-2044

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

First Aid Burn Cream is a topical medication designed to provide temporary relief from pain and itching caused by various skin irritations. You can use it for sunburn, minor burns, insect bites, as well as cuts and scrapes. This cream helps soothe discomfort and supports the healing process of your skin.

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 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. You should never apply it to your eyes or over large areas of your body. Avoid using it on deep puncture wounds, animal bites, or serious burns. Additionally, refrain from using large quantities, especially on raw surfaces or blistered areas, to prevent potential harm.

By following these guidelines, you can help ensure your safety while using this medication. If you have any questions or concerns, please consult your healthcare provider for more information.

Side Effects

You should only use this product on the skin and avoid applying it to your eyes, large areas of the body, deep puncture wounds, animal bites, or serious burns. It's important not to use 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 lasts longer than seven days, you should stop using the product and consult a doctor.

If you accidentally swallow the product, 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 your eyes or using it over 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 does not improve after 7 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 a medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, 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 breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

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

When it comes to using this medication in older adults, there is no specific information available in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of any age-related health considerations, as older adults may have different responses to medications. This includes factors like kidney function (renal impairment) and changes in cognitive abilities, which can affect how the body processes drugs.

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 should be used 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 you understand how to manage your treatment effectively while considering 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 (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 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. It’s important to avoid using any packets that are opened or torn, as this could compromise the product's safety and effectiveness. Always check the packaging before use to ensure it is intact.

Additional Information

No further information is available.

FAQ

What is First Aid Burn Cream used for?

First Aid Burn Cream is used for the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

How should I use First Aid Burn Cream?

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

Can children under 2 years use First Aid Burn Cream?

Children under 2 years should consult a doctor before using First Aid Burn Cream.

Are there any contraindications for using First Aid Burn Cream?

No specific contraindications are mentioned for First Aid Burn Cream.

What should I avoid when using First Aid Burn Cream?

Do not use First Aid Burn Cream in the eyes, over large areas of the body, on deep puncture wounds, animal bites, or serious burns, and avoid using it in large quantities over raw surfaces or blistered areas.

What should I do if the condition worsens or persists?

Stop using the cream and ask 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 I accidentally swallow First Aid Burn Cream?

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

Is First Aid Burn Cream safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before using First Aid Burn Cream.

How should I store First Aid Burn Cream?

Store First Aid Burn Cream in a cool, dry area at temperatures between 15º-25ºC (59º-77ºF) and do not use any opened or torn packets.

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 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 irritation, 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

Use of this product is contraindicated in the following situations:

The product should not be applied to the eyes. Application over large areas of the body, on deep puncture wounds, animal bites, or serious burns is also contraindicated due to the potential for adverse effects. Additionally, the use of large quantities, particularly on raw surfaces or blistered areas, is not recommended.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be used over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Caution is advised against the use of large quantities, particularly on raw surfaces or blistered areas.

Healthcare professionals should instruct patients to discontinue use and seek medical advice 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.

It is imperative to keep this product out of the reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients should be aware that the product is intended 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, the product 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.

In the event of accidental ingestion, it is crucial to seek medical assistance 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 warranted 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

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to monitor this population closely for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the presence of comorbidities and polypharmacy, which are common in geriatric patients and may necessitate dosage adjustments or increased monitoring.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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.

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 packets in a cool, dry area, maintaining a temperature range of 15º-25ºC (59º-77ºF). Healthcare professionals are advised to refrain from 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.