Burn Gel

Description

4048 Globe Burn Gel is a topical formulation designed for the management of minor burns. Each unit contains 0.9 grams of the gel, and the product is packaged in a total of 144 count. The formulation is intended for external use and is designed to provide a soothing effect on affected skin areas. 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 burns. It is intended for professional use only. There are no teratogenic or nonteratogenic effects reported in the available data.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that medical assistance be sought immediately if the product is swallowed. Additionally, patients should discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. It is imperative that the product is not applied in large quantities, especially over raw or blistered areas, to prevent potential adverse effects. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the affected area should be rinsed thoroughly with water.

In the case of ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Patients should be advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. Monitoring of these symptoms is essential to ensure appropriate management and intervention.

Side Effects

Patients should be aware that the product is intended for external use only. It is important to avoid using the product in large quantities, particularly over raw or blistered areas, and to refrain from applying it near the eyes. In the event of contact with the eyes, patients should rinse thoroughly with water.

Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of BURN GEL (lidocaine hci gel) during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering the use of this medication in pregnant patients. Healthcare professionals are advised to exercise caution and consider the potential risks and benefits when prescribing this medication to women of childbearing potential. Further studies may be necessary to fully understand the implications of using BURN GEL during pregnancy.

Lactation

There is no specific information regarding the use of BURN GEL (lidocaine hci gel) in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to nursing mothers. The effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

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, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

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 is deemed appropriate based on clinical judgment.

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 maintained until the patient is stabilized and further treatment can be determined based on the clinical scenario.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any symptoms observed, is vital for ongoing management and future reference.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 for patients to understand the potential risks associated with ingestion and the necessity of prompt action in such cases.

Additionally, healthcare providers should instruct patients to monitor their condition closely. If symptoms worsen or persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients should be encouraged to consult their healthcare provider for further evaluation and management. This guidance is crucial to ensure timely intervention and to prevent complications.

Storage and Handling

The product is supplied in packets that must be stored at room temperature. It is essential to avoid freezing the product to maintain its integrity. Healthcare professionals should ensure that any opened or torn packets are not used, as this may compromise the quality and safety of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)