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Lidocaine hydrochloride/Benzalkonium chloride

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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 2023
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 2023
Label revision date
December 15, 2025
Manufacturer
ProStat First Aid LLC
Registration number
M017
NDC root
58228-2309
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

PS-2309 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 conditions such as sunburn, minor burns, insect bites, cuts, and scrapes. This cream helps soothe your skin and alleviate discomfort, making it a helpful addition to your first aid supplies.

Uses

If you're dealing with discomfort from sunburn, minor burns, insect bites, cuts, or scrapes, this medication can help provide temporary relief from pain and itching. It’s designed to soothe these common skin irritations, making your recovery a bit more comfortable.

Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this medication, so you can use it with peace of mind.

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 help 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 you are taking the right steps for their safety and health.

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 use large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. Always follow these guidelines to ensure your safety and well-being.

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 7 days, you should stop using the product and consult a doctor. If you are pregnant or breastfeeding, please consult a healthcare professional before using it. Keep this product out of reach of children, and if it is 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 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 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 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 your child is 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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking multiple medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and overall treatment goals. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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).

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 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 PS-2309 First Aid Burn Cream used for?

PS-2309 First Aid Burn Cream is used for the temporary relief of pain and itching associated with sunburn, minor burns, insect bites, cuts, and scrapes.

How should I use PS-2309 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 this cream?

Children under 2 years should consult a doctor before using PS-2309 First Aid Burn Cream.

Are there any contraindications for using this cream?

There are no contraindications listed for PS-2309 First Aid Burn Cream.

What should I avoid when using this cream?

Do not use PS-2309 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 my condition worsens?

Stop using the cream and ask a doctor if your condition gets worse, clears up and recurs within a few days, or persists for more than 7 days.

Is it safe to use if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a healthcare professional before using PS-2309 First Aid Burn Cream.

How should I store this cream?

Store PS-2309 First Aid Burn Cream in a cool, dry area at a temperature between 15º-25ºC (59º-77ºF).

What should I do if the cream is swallowed?

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

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 sunburn, minor burns, insect bites, 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 is contraindicated in the following situations:

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

  • The product should not be applied over large areas of the body, on deep puncture wounds, animal bites, or serious burns, as these conditions may exacerbate adverse effects or hinder proper healing.

  • Avoid using large quantities, especially on raw surfaces or blistered areas, to prevent increased risk of irritation or systemic absorption.

Warnings and Precautions

The product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in the eyes, over large areas of the body, or on deep puncture wounds, animal bites, or serious burns. Additionally, the application of this product in large quantities, particularly over raw surfaces or blistered areas, is contraindicated.

Patients should be instructed to discontinue use and consult a healthcare provider 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.

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 should be aware of several important warnings and precautions. The product is intended for external use only and should not be applied in or around the eyes. It is contraindicated for use over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Additionally, it should not be used 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.

This product should be kept out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or the Poison Control Center should be contacted 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 use. For children aged 2 years and older, the affected area should be cleaned, and a small amount of the product should be applied 3 to 4 times daily. The 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication 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 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 lack of data 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 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 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. Contacting a Poison Control Center at 1-800-222-1222 is recommended for further guidance and support.

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 limits the assessment of potential risks associated with the use of the compound in question.

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 tamper-evident sealed packets to ensure integrity and safety. 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.