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First Aid Burn

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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
November 30, 2017
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
November 30, 2017
Manufacturer
Water-Jel Technologies
Registration number
part348
NDC root
59898-902
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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 help prevent infection and provide temporary relief from pain and itching caused by minor cuts, scrapes, and burns. It is intended for first aid use, making it a helpful addition to your home care supplies for treating everyday skin injuries.

Uses

You can use this product for first aid to help prevent infection and to provide temporary relief from pain and itching caused by minor cuts, scrapes, and burns. It’s designed to support your healing process and make you more comfortable as you recover from these common injuries.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this product, making it a safe option for use in various situations.

Dosage and Administration

To use this product effectively, start by cleaning the affected area thoroughly. After that, apply a small amount of the product directly to the area you want to treat. You can do this 1 to 3 times each day, depending on your needs. 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 first to ensure it’s safe and appropriate for their use. Always follow these guidelines to help achieve the best results.

What to Avoid

It's important to use this product safely to avoid potential issues. Do not apply it to your eyes or over large areas of your body. Additionally, you should not use it for longer than one week unless your doctor specifically instructs you to do so. Be cautious about using large quantities, especially on raw surfaces or blistered areas, as this can lead to complications.

While using this product, make sure to keep it away from your eyes to prevent irritation or injury. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only, so be sure to avoid applying it to your eyes or large areas of your body. It's important not to use it for more than one week unless your doctor advises you to do so, and avoid using large amounts, especially on raw or blistered skin. If you have deep or puncture wounds, animal bites, or serious burns, consult your doctor before using this product.

While using this product, make sure to keep it away from your eyes. If your condition worsens, symptoms last longer than seven days, or if your condition improves and then returns within a few days, stop using it and consult your doctor. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

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 for longer than one week unless your doctor advises otherwise, and be cautious not to apply it in large amounts, especially on raw or blistered skin.

Before using this product, consult your doctor if you have deep or puncture wounds, animal bites, or serious burns. While using it, make sure to keep it away from your eyes. If your condition worsens, symptoms last more than seven days, or if the issue clears up and then returns within a few days, stop using the product and contact your doctor.

Always keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior. If you notice anything concerning, don’t hesitate to reach out for help. Remember, it's always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. There may be potential risks to your fetus, but specific studies or data are not available to clarify these risks. Therefore, it is crucial to consult your doctor before using this product.

If you decide to use it, do so only if it is clearly needed and after discussing it with your healthcare professional. There are no specific dosage modifications mentioned for pregnant women, so seeking guidance from your healthcare provider is essential to ensure your safety and that 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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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 help them by first cleaning the affected area and then applying a small amount of the product. This can be done 1 to 3 times a day, and you may cover the area with a sterile bandage if needed. 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 regarding its use. This means that there are no recommended age-related considerations, dosage adjustments, or safety concerns specifically for elderly patients.

As always, it's important for you or your caregiver to discuss any medications with your healthcare provider, especially if you have any underlying health conditions or are taking other medications. Your doctor can help ensure that the treatment is safe and appropriate for your individual needs.

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).

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 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 way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and avoid freezing it. It's important to use the tamper-evident sealed packets provided; if you notice that a packet is opened or torn, do not use the product, as this could compromise its safety.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure it is safe for use.

Additional Information

You should apply a small amount of this topical product to the affected area 1 to 3 times daily if you are an adult or a child aged 2 years and older. Before using it, consult your doctor if you have deep or puncture wounds, animal bites, or serious burns. If your condition worsens, symptoms last more than 7 days, or if the issue clears up and then returns within a few days, stop using the product and seek medical advice.

If you experience a serious reaction to this product, you can report it by calling 800-275-3433.

FAQ

What is First Aid/Burn Cream used for?

First Aid/Burn Cream is used to help prevent infection and provide temporary relief from pain and itching associated with minor cuts, scrapes, and burns.

How should I use First Aid/Burn Cream?

For adults and children 2 years and older, clean the affected area and apply a small amount of the cream 1 to 3 times daily. It may be covered with a sterile bandage.

Can children under 2 years use this product?

Consult a doctor before using First Aid/Burn Cream on children under 2 years of age.

Are there any warnings for using this cream?

Yes, avoid contact with eyes, do not use on large areas of the body, and do not use for longer than 1 week unless directed by a doctor.

What should I do if my condition worsens?

Stop using the cream and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if the condition clears up and occurs again within a few days.

Is this product safe to use during pregnancy?

The safety of First Aid/Burn Cream during pregnancy has not been established, so consult a doctor if you are pregnant or planning to become pregnant.

What should I do if the cream is swallowed?

Keep First Aid/Burn Cream out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

How should I store First Aid/Burn Cream?

Store the cream at room temperature and do not freeze. Use tamper-evident sealed packets and do not use if the packet is opened or torn.

Packaging Info

Below are the non-prescription pack sizes of First Aid Burn (benzalkonium chloride, lidocaine hydrochloride). 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

First Aid/Burn Cream is formulated for the topical treatment of minor burns and skin irritations. This cream is designed to provide soothing relief and promote healing in affected areas. It is intended for external use only and should be applied to clean, dry skin. The cream's consistency allows for easy application and absorption, facilitating effective treatment of minor injuries.

Uses and Indications

This drug is indicated for first aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes, and burns.

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 1 to 3 times daily, depending on the severity of the condition. 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

Use of this product is contraindicated in the following situations:

Application in the eyes or over large areas of the body is prohibited due to the potential for adverse effects. Prolonged use beyond one week is contraindicated unless specifically directed by a healthcare professional, as extended application may lead to complications. Additionally, the use of large quantities, particularly on raw surfaces or blistered areas, is not recommended due to the increased risk of irritation and systemic absorption.

During use, it is essential to avoid contact with the eyes to prevent irritation or injury.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes or over large areas of the body. It should not be used for longer than one week unless specifically directed by a healthcare professional. Caution is advised against applying large quantities, particularly over raw surfaces or blistered areas.

Healthcare professionals should advise patients to consult a doctor prior to use if they have deep or puncture wounds, animal bites, or serious burns. During the use of this product, it is imperative to avoid contact with the eyes.

Patients should be instructed to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than seven days, or if the condition resolves and then recurs within a few days.

It is essential 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 should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use in the eyes or for application over large areas of the body. The product should not be used for longer than one week unless directed by a healthcare professional, and it should not be applied in large quantities, particularly over raw surfaces or blistered areas.

Before using this product, patients are advised to consult a doctor if they have deep or puncture wounds, animal bites, or serious burns. During use, it is important to avoid contact with the eyes.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven days, or if the condition clears up and then recurs within a few days. Additionally, this product should be kept out of the reach of children. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for First Aid Burn.
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 affected area should be cleaned, and a small amount of the product should be applied 1 to 3 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, as the prescribing information does not provide any age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety in elderly patients is advised, given the potential for variability in drug response and the presence of comorbidities that may affect treatment outcomes.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

No specific dosage modifications for pregnant women are mentioned; therefore, it is essential for healthcare professionals to provide guidance tailored to the individual patient. This product should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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 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 or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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

Serious reactions to this product have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number, 800-275-3433.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to use the product in or around the eyes, or to apply it over large areas of the body.

Patients should be informed that the product should not be used for longer than one week unless directed by a healthcare professional. They should also be cautioned against using large quantities, especially on raw surfaces or blistered areas.

Healthcare providers should encourage patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if the condition improves and then recurs within a few days. Additionally, patients should be reminded to avoid contact with the eyes while using this product.

Finally, it is essential to advise patients to consult a doctor before using the product if they have deep or puncture wounds, animal bites, or serious burns.

Storage and Handling

The product is supplied in tamper-evident sealed packets. It is essential to inspect the packets prior to use; do not utilize any packet that is opened or torn.

For optimal storage, the product should be maintained at room temperature. It is crucial to avoid freezing the product to ensure its integrity and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area 1 to 3 times daily for adults and children aged 2 years and older. Clinicians should advise patients to consult a doctor prior to use if they have deep or puncture wounds, animal bites, or serious burns. Patients are also instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if the condition resolves and then recurs within a few days.

For any serious reactions associated with the product, patients can report their experiences by calling 800-275-3433. No additional information is available regarding laboratory tests or abuse potential.

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

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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.