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First Aid Burn Cream

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This product has been discontinued

Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
February 3, 2020
Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
February 3, 2020
Manufacturer
Davemed Healthcare Co. , Ltd
Registration number
part348
NDC root
70897-001

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Drug Overview

First Aid Burn Cream is a topical medication designed to provide first aid for minor cuts, scrapes, and burns. It helps prevent infection while offering temporary relief from pain and itching associated with these injuries. This cream is a supportive option for managing minor skin irritations and promoting healing.

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 minor injuries.

Rest assured, there are no concerns regarding teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which are not related to fetal development) associated with this product.

Dosage and Administration

To use this medication effectively, start by cleaning the area that needs treatment. Once the area is clean, apply a small amount of the medication. You should do this no more than three times a day. If you prefer, you can cover the treated area with a sterile bandage to help protect it.

Remember to follow these steps consistently for the best results. If you have any questions or concerns about your treatment, don’t hesitate to reach out to your healthcare provider.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not use it in your eyes, in large quantities, or on raw blistered areas, deep punctured wounds, animal bites, or serious burns. Additionally, limit your use to no more than one week to prevent any complications.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help ensure your safety and well-being. Always consult with a healthcare professional if you have any questions or concerns about your treatment.

Side Effects

It's important to note that this product is for external use only. This means you should not apply it to areas inside your body, such as your mouth or eyes. Always follow the guidelines for safe use to avoid any potential issues. If you have any concerns or experience unusual reactions, please consult a healthcare professional.

Warnings and Precautions

This product is for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

Please avoid using this product in your eyes, in large amounts, or on raw, blistered areas, deep puncture wounds, animal bites, or serious burns. Additionally, do not use it for more than one week. If you experience any adverse effects or have concerns, stop using the product and call your doctor.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

The safety of this product during pregnancy has not been established, which means that it is not known if it could harm you or your developing baby. Therefore, it is generally not recommended for use in pregnant women unless your healthcare provider determines that the potential benefits outweigh any risks to the fetus (the developing baby).

If you are pregnant or planning to become pregnant, it’s important to discuss any medications or treatments with your doctor to ensure the best care for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

You should also avoid using this medication in your child's eyes, in large amounts, on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. Additionally, do not use it for more than one week. Always follow these guidelines to ensure your child's safety.

Geriatric Use

When considering the use of First Aid Burn Cream (lidocaine cream) for older adults, it's important to note that the drug insert does not provide specific information about how this medication should be adjusted or used differently for elderly patients. This means there are no special dosage changes or safety precautions outlined specifically for older adults.

As always, if you or a caregiver are considering this treatment, it's wise to consult with a healthcare professional to ensure it is appropriate for your individual health needs, especially if there are any underlying health conditions or other medications involved.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. Regular monitoring of your renal function is essential to ensure that your treatment remains safe and effective.

For those with severe renal impairment, special considerations are necessary. Make sure to discuss your kidney health with your healthcare provider, as they can guide you on the appropriate dosage and any additional precautions you may need to take.

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 determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is First Aid Burn Cream used for?

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

How should I apply First Aid Burn Cream?

Clean the affected area and apply a small amount of the cream no more than three times daily. It may be covered with a sterile bandage.

Are there any contraindications for using First Aid Burn Cream?

Do not use First Aid Burn Cream in the eyes, in large quantities, over raw blistered areas, on deep punctured wounds, animal bites, or serious burns, and not for more than one week.

Is First Aid Burn Cream safe to use during pregnancy?

The safety of First Aid Burn Cream during pregnancy has not been established, and it is not recommended unless the potential benefits outweigh the risks to the fetus.

What should I do if I accidentally ingest First Aid Burn Cream?

If ingested, seek medical help or contact a Poison Control Center immediately.

What precautions should I take when using First Aid Burn Cream?

First Aid Burn Cream is for external use only. Keep it out of reach of children and monitor for any adverse reactions.

How should I store First Aid Burn Cream?

Store First Aid Burn Cream at room temperature.

Packaging Info

Below are the non-prescription pack sizes of First Aid Burn Cream (lidocaine). 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

The product is a topical cream indicated for the treatment of burns. It contains active ingredients that facilitate healing and alleviate pain. This formulation is intended for external use only. The cream comprises inactive ingredients such as water, glycerin, and a selection of emulsifiers and preservatives. It is packaged in a tube to ensure convenient application.

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

The affected area should be cleaned thoroughly prior to application. A small amount of the medication should be applied to the affected area, not exceeding three times daily. If desired, the area may be covered with a sterile bandage following application to protect the site and enhance the effectiveness of the treatment.

Contraindications

Use is contraindicated in the following situations:

  • Application in or around the eyes.

  • Use in large quantities.

  • Application over raw, blistered areas, deep punctured wounds, animal bites, or serious burns.

  • Prolonged use beyond one week.

These contraindications are established to prevent potential adverse effects associated with inappropriate use.

Warnings and Precautions

External use only. Ingestion of this product necessitates immediate medical attention or contact with a Poison Control Center.

The product is contraindicated for use in the following situations:

  • Application in or around the eyes is strictly prohibited.

  • It should not be used in large quantities.

  • The product must not be applied over raw, blistered areas, deep punctured wounds, animal bites, or serious burns.

  • Continuous use beyond one week is not recommended.

Healthcare professionals should ensure that patients are aware of these warnings to prevent adverse effects and ensure safe usage.

Side Effects

Patients should be advised that the product is for external use only. There are no additional specific adverse reactions or side effects reported in clinical trials or postmarketing experiences. It is essential for patients to adhere strictly to the recommended usage guidelines to minimize any potential risks associated with improper use.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for First Aid Burn Cream.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

This medication is contraindicated for use in the eyes, in large quantities, over raw or blistered areas, on deep punctured wounds, animal bites, or serious burns. Additionally, it should not be used for more than one week.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for First Aid Burn Cream (lidocaine cream). As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the lack of targeted clinical data.

It is advisable for healthcare providers to monitor elderly patients closely for any potential adverse effects or unusual responses to treatment, considering the general physiological changes associated with aging that may affect drug metabolism and response.

Pregnancy

The safety of this product during pregnancy has not been established. Use is not recommended in pregnant women unless the potential benefits outweigh the risks to the fetus. Healthcare professionals should carefully consider the risk-to-benefit ratio when prescribing this product to pregnant patients, as the potential for adverse fetal outcomes remains uncertain. It is essential to counsel women of childbearing potential regarding the importance of effective contraception during treatment and to discuss any plans for pregnancy with their healthcare provider.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients to ensure safe and effective dosing. Dosage adjustments should be guided by creatinine clearance levels, with particular attention given to patients with severe renal impairment, who may require special considerations in their treatment regimen.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of ingestion, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt intervention in case of accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

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.

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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.