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First Aid Burn

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Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 g
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
June 4, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
June 4, 2024
Manufacturer
Epic Medical Supply Corp
Registration number
M017
NDC root
82749-009
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 can use this medication for temporary relief of pain and itching caused by various skin issues. It is effective for conditions such as sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes. This means that if you experience discomfort from any of these common skin problems, this drug can help soothe your symptoms and provide some comfort.

Uses

You can use this medication for temporary relief from pain and itching caused by various skin issues. It is effective for conditions such as sunburn, minor burns, insect bites, and minor skin irritations. Additionally, it can help soothe discomfort from cuts and scrapes.

This product is designed to provide quick relief, making it a handy option for everyday skin irritations. Whether you've spent too long in the sun or have a pesky insect bite, this medication can help you feel more comfortable.

Dosage and Administration

To use this product effectively, start by cleaning the affected area thoroughly. For adults and children aged 2 years and older, apply a small amount of the product to the area 3 to 4 times each day. If desired, you can cover the area with a sterile bandage to help protect it.

If you are considering using this product for a child under 2 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for their use. Always follow these guidelines to help promote healing and avoid complications.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this medication, it's important to be aware of certain warnings and potential side effects. 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. 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, it's advisable to speak with a healthcare professional before using this medication. Always keep it out of reach of children, and 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 in your eyes or on large areas of your body. It should not be applied to 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. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product.

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 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 expert 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 your child is 2 years old or older, you can apply a small amount of this product to the affected area 3 to 4 times a day after cleaning it. It’s okay to cover the area with a sterile bandage if needed. However, if your child is under 2 years old, it’s important to consult a doctor before using this product. Always prioritize your child's safety and follow these guidelines for proper use.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to use the tamper-evident sealed packets provided, as these help guarantee that the product has not been compromised. If you notice any packets that are opened or torn, do not use them, as this could affect the product's safety and performance. Always handle the packets with care to maintain their integrity.

Additional Information

You should apply this product topically to the affected area. For adults and children aged 2 years and older, clean the area first, then apply a small amount of the product 3 to 4 times daily. If desired, you can cover the area with a sterile bandage. If the user is a child under 2 years old, it's important to consult a doctor before use.

FAQ

What is this drug used for?

This drug is used for temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

How should I use this drug?

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

What should I do if I have a child under 2 years?

If your child is under 2 years old, consult a doctor before use.

Are there any warnings I should be aware of?

Yes, this product 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 my condition worsens?

Stop use and ask a doctor if the 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 use.

What should I do if the product is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

How should I store this drug?

Store at room temperature and use tamper-evident sealed packets. Do not use any opened or torn packets.

Packaging Info

Below are the non-prescription pack sizes of First Aid Burn (lidocaine hydrochloride, benzalkonium chloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for First Aid Burn.
Details

Drug Information (PDF)

This file contains official product information for First Aid Burn, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 is to 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 healthcare professional before use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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.

In cases of pregnancy or breastfeeding, it is essential for individuals to consult a healthcare professional prior to use to ensure safety for both the mother and child.

This product must be kept out of reach of children. In the event of accidental 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 for external use only. It is contraindicated for use in the eyes and should not be applied over large areas of the body, on deep puncture wounds, animal bites, or serious burns. Additionally, the product 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. Special consideration should be given to pregnant or breastfeeding individuals, who should seek advice from a healthcare professional prior to use.

It is crucial to keep the product 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 no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of First Aid Burn (lidocaine hydrochloride, benzalkonium chloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for First Aid Burn.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply a small amount of this product to the affected area 3 to 4 times daily, and the area may be covered with a sterile bandage. For children under 2 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

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 mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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. 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from areas accessible to children, to ensure their safety.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to store the packets at room temperature to maintain their quality. Healthcare professionals are advised not to use any packets that are opened or torn, as this may compromise the product's efficacy and safety.

Additional Clinical Information

The product is administered topically. For adults and children aged 2 years and older, the affected area should be cleaned, and a small amount of the product applied 3 to 4 times daily, which may be covered with a sterile bandage. For children under 2 years, it is advised to consult a doctor prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for First Aid Burn, 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, 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.