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Firstar 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)
Marketed in the U.S.
Since 2024
Label revision date
July 2, 2024
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 2024
Label revision date
July 2, 2024
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-040

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 the temporary relief of pain associated with minor cuts, scrapes, and burns. It works by helping to protect the affected area from harmful bacteria, which can aid in the healing process. This makes it a useful option for managing discomfort and preventing infection in minor skin injuries.

Uses

You can use this medication for the temporary relief of pain caused by minor cuts, scrapes, and burns. It also helps protect your skin from harmful bacteria, which can prevent infections and promote healing.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for use.

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 keep this medication out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always use it responsibly and as directed.

Side Effects

It's important to use this product carefully, as it is meant for external use only. You should avoid applying it in or around your eyes, using it in large amounts, or putting it on raw or blistered skin. Additionally, do not use it on deep puncture wounds, animal bites, or serious burns. If you need to use it for more than one week, please consult your doctor first.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or in large amounts. Do not apply it to raw or blistered skin, deep puncture wounds, animal bites, or serious burns. It's important to limit use to no more than one week unless your doctor advises otherwise.

If you accidentally swallow this product, seek medical help immediately or contact a Poison Control Center. Always prioritize your safety and well-being when using any medication.

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, or if you are unsure, 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 be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

The safety of lidocaine hydrochloride cream during pregnancy has not been established, which means that it may not be safe for you or your developing baby. Because of potential risks to the fetus, it is advised that you do not use this product if you are pregnant.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this cream. They can help you understand the risks and determine the best options for your health and the health 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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

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

Additionally, you should not use this medication for more than one week unless a doctor specifically instructs you to do so. Always follow your healthcare provider's guidance to ensure the safety and well-being of your child.

Geriatric Use

While there is no specific information about the use of FIRSTAR BURN (lidocaine hydrochloride cream) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this cream. They can provide guidance tailored to your individual health needs and any other medications you may be taking.

Always prioritize safety and ensure that any treatment aligns with your overall health plan, especially if you or your loved ones are managing multiple health conditions.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 remember that even if no interactions are listed, discussing all your medications and any lab tests with your healthcare provider is crucial. This helps to avoid any potential issues and ensures that you receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. It's important to keep the packets sealed until you're ready to use them, as they come in tamper-evident sealed packets designed to protect their contents. If you notice any opened or torn packets, do not use them, as this could compromise the safety and effectiveness of the product. Always handle the packets with care to maintain their integrity.

Additional Information

You should apply this medication topically, using a small amount no more than three times a day. It's important to follow this guideline to ensure safe and effective use. If you have any questions about how to use the medication or its effects, be sure to consult your healthcare provider for more information.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of pain associated with minor cuts, scrapes, and burns.

How does this drug work?

It helps protect against harmful bacteria.

How should I apply this drug?

Clean the affected area and apply a small amount not more than 3 times daily. It may be covered with a sterile bandage.

Are there any contraindications for using this drug?

There are no contraindications listed for this drug.

What should I do if I swallow this drug?

If swallowed, get medical help or contact a Poison Control Center directly.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding the use of this drug by nursing mothers.

What precautions should I take when using this drug?

For external use only; do not use in the eyes, in large quantities, over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns. Do not use for more than one week unless directed by a doctor.

How should I store this drug?

Store at room temperature and do not use any opened or torn packets.

Packaging Info

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

Packaging configurations for Firstar Burn.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor cuts, scrapes, and burns. Additionally, it helps protect against harmful bacteria, contributing to the overall management of minor skin injuries.

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.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product must not be applied in or around the eyes, nor should it be used in large quantities. It is contraindicated for application over raw or blistered areas, deep puncture wounds, animal bites, or serious burns. The duration of use should not exceed one week unless specifically directed by a healthcare professional.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in the eyes, in large quantities, over raw or blistered areas, on deep puncture wounds, animal bites, or serious burns. Additionally, the product should not be used for more than one week unless directed by a healthcare professional.

While specific adverse reactions have not been detailed in the provided information, the warnings highlight the importance of adhering to the recommended usage guidelines to minimize the risk of potential adverse effects. Patients are advised to consult with their healthcare provider if they experience any unexpected reactions or if they have concerns regarding the use of this product.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Firstar Burn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Firstar Burn.
Details

Pediatric Use

Pediatric patients should be monitored closely, as the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

The use of this product in pediatric populations is limited to a duration of one week unless otherwise directed by a healthcare professional. Extended use beyond this period should be approached with caution and under medical supervision.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for FIRSTAR BURN (lidocaine hydrochloride cream). As there is no available information regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients.

It is advisable to monitor these patients closely for any potential adverse effects, given the lack of targeted data. Clinical judgment should guide the decision-making process, taking into account the individual health status and comorbidities of geriatric patients.

Pregnancy

The safety of lidocaine hydrochloride cream during pregnancy has not been established. The use of this product is contraindicated in pregnant patients due to potential risks to the fetus. Women who are pregnant or planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes that may be appropriate based on the substance involved.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, despite the lack of specific information provided.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. Instruct patients that if the medication is swallowed, they should seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and the necessary steps to take in case of an emergency.

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 medication is administered topically, with a recommended application of a small amount not exceeding three times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Firstar 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 Firstar 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.