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Burn Cream

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Active ingredients
  • Lidocaine Hydrochloride 0.005 g/1 g
  • Benzalkonium Chloride 0.0013 g/1 g
Other brand names
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 2022
Label revision date
July 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 0.005 g/1 g
  • Benzalkonium Chloride 0.0013 g/1 g
Other brand names
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 2022
Label revision date
July 12, 2024
Manufacturer
Trifecta Pharmaceuticals USA LLC
Registration number
M013
NDC root
69396-105
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

4050 GLOBE BURN CREAM is a topical cream designed to provide temporary relief from pain associated with minor cuts, scrapes, and burns. In addition to alleviating discomfort, it helps protect the affected area from harmful bacteria, promoting a safer healing environment.

This cream comes in a package containing 144 units, each with a weight of 0.9 grams. It is intended for use on minor skin injuries, making it a helpful option for everyday accidents.

Uses

You can use this product 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 product, making it a safe option for many users.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area thoroughly. Once it’s 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 area with a sterile bandage (a clean dressing that helps protect the area from infection) after applying the medication. This will help keep the area clean and promote healing.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, you should seek medical help or contact a Poison Control Center right away. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

It's important to be aware of some key warnings when using this product. It is meant for external use only, so you should avoid applying it to your eyes or using it in large amounts. Additionally, do not use it on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. If you find that you need to use it for more than one week, please consult your doctor for guidance.

Warnings and Precautions

This product is intended for external use only. You should avoid using it in your eyes, in large amounts, or on raw or blistered skin. It is also important not to apply it over deep puncture wounds, animal bites, or serious burns. If you need to use it for more than one week, please consult your doctor first.

If you accidentally swallow this product, seek medical help or contact a Poison Control Center right away. 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, 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

When it comes to using BURN CREAM (which contains benzalkonium chloride and lidocaine) during pregnancy, there is currently no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that the effects of this cream on you or your developing baby are not well-studied.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

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. This means you can continue to breastfeed without worrying about potential effects from this product.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help or contact a Poison Control Center right away. Taking these precautions can help ensure your child's safety.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 in a cool, dry area where the temperature remains between 15° to 25°C (59° to 77°F). This helps maintain its quality. Always use the tamper-evident sealed packets provided, as these indicate that the product has not been compromised. If you notice any opened or torn packets, do not use them, as they may not be safe. Following these guidelines will help you handle the product properly and ensure its reliability.

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 4050 GLOBE BURN CREAM used for?

It provides temporary relief of pain associated with minor cuts, scrapes, and burns, and helps protect against harmful bacteria.

How should I use 4050 GLOBE BURN CREAM?

Clean the affected area and apply a small amount of the cream no more than 3 times daily. It may be covered with a sterile bandage.

Are there any contraindications for using this cream?

No specific contraindications are listed for 4050 GLOBE BURN CREAM.

What should I do if I accidentally swallow the cream?

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

Are there any warnings I should be aware of?

This cream is for external use only. Do not use it 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.

Is 4050 GLOBE BURN CREAM safe to use during pregnancy or while nursing?

There is no specific information regarding the use of this cream during pregnancy or lactation, and no warnings are provided for nursing mothers.

How should I store 4050 GLOBE BURN CREAM?

Store the cream in a cool, dry area at temperatures between 15° to 25°C (59° to 77°F) and use tamper-evident sealed packets.

Packaging Info

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

Packaging configurations for Burn Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

4050 Globe Burn Cream is a topical formulation designed for the management of burn injuries. Each unit contains 0.9 grams of the active ingredient, and the product is packaged in a total of 144 units per carton. The cream is intended for external use and is formulated to provide a protective barrier to the affected area. The product is regulated under the Center for Drug Evaluation and Research (CDER) guidelines.

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

There are no specific contraindications listed for this product. However, it is imperative to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Warnings and Precautions

For external use only. This product is contraindicated for application in or around the eyes. It should not be used in large quantities or applied over raw or blistered areas, deep puncture wounds, animal bites, or serious burns.

Healthcare professionals should advise patients not to use this product for more than one week unless directed by a physician. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted.

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 data, 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 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 Burn Cream (benzalkonium chloride, lidocaine hci). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn Cream.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of BURN CREAM (benzalkonium chloride, lidocaine HCl cream) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for this population. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential. Given the lack of data, it is advisable to exercise caution and to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information may necessitate individualized assessment and monitoring based on the patient's overall clinical status and renal function.

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 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 consider 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management 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 compound in these areas.

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 or contact a Poison Control Center immediately. This information is vital for ensuring patient safety and prompt intervention if necessary.

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 15° to 25°C (59° to 77°F). Healthcare professionals should refrain from using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

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 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 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.