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Burn Relief

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Active ingredient
Lidocaine Hydrochloride 20 g/1 L
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
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 ingredient
Lidocaine Hydrochloride 20 g/1 L
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Spray
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
M017
NDC root
69396-107
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

4049 GLOBE BURN SPRAY is a product designed to provide temporary pain relief for minor burns. If you experience discomfort from a minor burn, this spray can help soothe the affected area and alleviate your pain. It is important to use it as directed to ensure effective relief.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain. It’s designed to help ease the discomfort you may experience while your skin heals. Remember, this is specifically for minor burns, so if your injury is more severe, it’s important to seek medical attention.

Dosage and Administration

To use the burn spray effectively, start by cleaning the affected area thoroughly. Once it's clean, spray an even layer of the burn spray over the area. You can do this up to 3 to 4 times a day, but make sure not to exceed this limit for the best results.

It's important to note that this burn spray is not recommended for children under 12 years of age, so please avoid using it on younger individuals. Always follow these guidelines to ensure safe and effective use of the product.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should not apply it in large quantities, especially on raw or blistered areas of your skin. Additionally, be careful not to get the medication near your eyes; if it does come into contact with your eyes, rinse them thoroughly with water.

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 the effectiveness of the treatment.

Side Effects

It's important to use this product only on the skin and to be aware of how it may affect you. If your condition worsens or does not improve after 7 days, or if it seems to clear up and then come back, you should stop using the product and consult a doctor. This ensures that you receive the appropriate care and guidance for your health.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Do not apply this product in large amounts, especially on raw or blistered skin, and be careful to keep it away from your eyes. If it accidentally gets into your eyes, rinse them thoroughly with water.

If your condition worsens, does not improve after 7 days, or clears up and then comes back, stop using the product and consult 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 or symptoms of an overdose for this medication, general signs can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, 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 action can make a significant difference.

Pregnancy Use

While the information provided does not specify any particular safety concerns or precautions for use during pregnancy, it is important to approach any medication with care. There are no dosage modifications recommended for pregnant individuals, which suggests that the standard dosing may be considered safe. However, always consult with your healthcare provider before starting or continuing any medication during pregnancy to ensure it is appropriate for your specific situation. Your health and the health of your baby are the top priority, so open communication with your doctor is essential.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations regarding the use of this product while nursing. Additionally, there are no statements indicating that the product is excreted in breast milk or that it poses any risk to your infant. This means you can use the product without concern for its effects on your milk production or your baby's health.

Pediatric Use

It's important to know that this medication should not be used in children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that are safe and appropriate for their age. Always prioritize your child's health and follow medical advice regarding their treatment.

Geriatric Use

When considering medication for older adults, it's important to note that this particular drug should not be used in children under 12 years of age. If you are caring for an older adult, ensure that they are aware of this guideline, as it helps to prevent any potential misuse or adverse effects. Always consult with a healthcare professional to discuss the appropriate use and any specific concerns related to age or 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. This means that there are no tailored recommendations for how your kidney function might affect the use of this medication.

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

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 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 and safety of your product, store it at a controlled room temperature between 68º-77ºF (20º-25ºC). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply the burn spray topically, which means you will spray an even layer over the cleaned affected area. It is recommended to do this no more than 3 to 4 times a day for best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is 4049 GLOBE BURN SPRAY used for?

4049 GLOBE BURN SPRAY provides temporary pain relief associated with minor burns.

How should I use 4049 GLOBE BURN SPRAY?

Spray an even layer over the cleaned affected area no more than 3-4 times daily.

Is 4049 GLOBE BURN SPRAY safe for children?

No, it should not be used on children under 12 years of age.

What should I do if I accidentally get 4049 GLOBE BURN SPRAY in my eyes?

If the spray gets in your eyes, rinse thoroughly with water.

What should I do if my condition worsens or does not improve?

Stop use and ask a doctor if the condition worsens or persists for more than 7 days.

What are the storage conditions for 4049 GLOBE BURN SPRAY?

Store at controlled room temperature between 68º-77ºF (20º-25ºC).

Are there any specific warnings for using 4049 GLOBE BURN SPRAY?

Yes, it is for external use only and should not be used in large quantities, especially over raw or blistered areas.

Can I use 4049 GLOBE BURN SPRAY while pregnant or nursing?

The product does not provide specific warnings or considerations for use during pregnancy or nursing.

Packaging Info

Below are the non-prescription pack sizes of Burn Relief (lidocaine hci 2.0%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

4049 Globe Burn Spray is a topical formulation available in a 2-ounce spray container. The product is designed for the management of burn injuries. It is classified under the relevant regulatory guidelines and has been assigned a specific revision date of July 10, 2024, by the Center for Drug Evaluation and Research (CDER).

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. It is intended for use in patients experiencing discomfort due to such injuries.

Dosage and Administration

The burn spray should be applied as an even layer over the cleaned affected area. The recommended frequency of application is not more than 3 to 4 times daily.

This product is contraindicated for use in children under 12 years of age. Healthcare professionals should ensure that the area is properly cleaned prior to application to maximize the effectiveness of the treatment.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities, particularly over raw or blistered areas, is not recommended due to the potential for adverse effects. Additionally, contact with the eyes is contraindicated; in the event of accidental exposure, the eyes should be rinsed thoroughly with water.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

This product should not be used in large quantities, especially on raw or blistered areas. Care must be taken to avoid contact with the eyes; should contact occur, the eyes must be rinsed thoroughly with water.

Healthcare professionals should advise patients to discontinue use and consult a doctor if the condition worsens, persists for more than 7 days, or if the condition appears to improve and then returns.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Burn Relief (lidocaine hci 2.0%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals should consider alternative treatments for pediatric patients who fall within this age range.

Geriatric Use

Elderly patients may require careful consideration when prescribing this medication. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should assess the overall health status and comorbidities of geriatric patients, as these factors may influence the safety and efficacy of the treatment. Monitoring for potential adverse effects is recommended, given that elderly patients may have altered pharmacokinetics and pharmacodynamics.

Dosage adjustments may be necessary based on individual patient characteristics, including renal and hepatic function, which can be affected by age. Regular evaluation and adjustment of the treatment regimen may be warranted to ensure optimal therapeutic outcomes while minimizing risks.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or considerations regarding the use of this product in lactating mothers. Additionally, there are no statements concerning 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies in any suspected cases.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 68º-77ºF (20º-25ºC) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging. Special handling needs include avoiding exposure to extreme temperatures and direct sunlight to preserve the integrity of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of an even layer of burn spray over the cleaned affected area, not exceeding 3-4 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 Relief, 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 Relief, 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.