Exchange Select Burn Relief

Description

BURN RELIEF Pain Relieving Gel contains Lidocaine as its active ingredient, which is indicated for cooling, soothing, and relieving sunburned skin. The product is presented in a gel dosage form, with a net weight of 8 oz (227 g).

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various dermatological conditions. It helps relieve and soothe pain from sunburn, minor burns, cuts, scrapes, skin irritations, and insect bites.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 unless directed by a physician. Healthcare professionals are advised to consult with a doctor for appropriate guidance in such cases.

Contraindications

Use is contraindicated in the following situations:

• If conditions worsen or symptoms persist for more than 7 days, as this may indicate a more serious underlying condition that requires medical evaluation.

• If symptoms resolve and then recur within a few days, as this may suggest an unresolved issue that necessitates further assessment.

• Contact with eyes should be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Care should be taken to avoid contact with the eyes during application. In the event of accidental contact, it is advisable to rinse thoroughly with water and seek medical attention if irritation persists.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: conditions worsen, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product must be kept out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only and should not be applied in large quantities, especially over raw surfaces or blistered areas. Care should be taken to avoid contact with the eyes during application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, it is recommended to seek medical advice.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Exchange Select Burn Relief (lidocaine hydrochloride). 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 infants and children under 2 years of age, the use of this medication is not recommended; healthcare professionals should be consulted for guidance.

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.

Due to the lack of data, it is advisable to closely monitor elderly patients for any potential adverse effects and to consider individual patient factors when determining the appropriateness of therapy.

Pregnancy

There are no specific statements regarding the use of EXCHANGE SELECT BURN RELIEF PAIN RELIEVING lidocaine hydrochloride gel during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant patients, as the potential effects on fetal outcomes have not been established. It is advisable to weigh the benefits against any potential risks when prescribing this medication to women of childbearing potential.

Lactation

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

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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay if the substance has been ingested.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. The specific symptoms of overdosage may vary depending on the substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

It is imperative that healthcare providers remain vigilant and prepared to initiate supportive care and symptomatic treatment as necessary, following established protocols for managing overdosage 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 assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than seven days. Additionally, patients should be informed to stop using the product and reach out to a healthcare professional if symptoms resolve but then reoccur within a few days.

Healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product, as this could lead to adverse effects. Clear communication of these points will help ensure patient safety and effective use of the product.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication 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 Exchange Select Burn Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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