Menthol

Description

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

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Healthcare professionals should refer to the prescribing information for detailed indications and usage.

Limitations of use and any potential teratogenic or nonteratogenic effects have not been specified in the provided information. It is essential for healthcare providers to evaluate the appropriateness of this drug based on individual patient circumstances and existing clinical data.

Dosage and Administration

For adults and children aged 12 years and older, a thin layer of the medication should be applied to the affected area three to four times daily. It is important to ensure that the application is consistent and covers the entire affected area for optimal results.

For children under 12 years of age, it is recommended to consult a physician prior to use to determine appropriate treatment options and dosages.

After application, healthcare professionals should advise patients to wash their hands thoroughly to prevent unintentional transfer of the medication to other areas or individuals.

Contraindications

Use is contraindicated in the following situations:

• Application on wounds or damaged skin due to the potential for irritation or adverse effects.

• Concurrent use with a heating pad, as this may increase the risk of skin burns or other complications.

• In children under 12 years of age, due to insufficient safety and efficacy data in this population.

• During pregnancy or breastfeeding, as the effects on fetal or infant health have not been established.

Warnings and Precautions

For external use only, this product must be applied with caution to avoid contact with the eyes and mucous membranes. It is imperative that the area of application is not tightly bandaged to prevent potential complications.

General precautions should be observed when using this product. It is contraindicated for use on wounds or damaged skin, and it should not be used in conjunction with a heating pad. Additionally, this product is not recommended for children under 12 years of age, nor should it be used by individuals who are pregnant or breastfeeding.

Patients are advised to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops. These steps are crucial to ensure patient safety and to address any potential adverse reactions promptly.

Side Effects

Patients using this product should be aware of specific warnings and recommendations regarding its use. The product is intended for external use only, and contact with the eyes and mucous membranes should be strictly avoided. Additionally, it is advised not to bandage the area tightly.

In the event that the condition worsens or symptoms persist for more than 7 days, patients are instructed to stop using the product and consult a physician. Furthermore, if symptoms initially clear up but then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought promptly. These precautions are essential to ensure the safety and well-being of patients during treatment.

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 Painzone Light. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For children in this age group, consultation with a physician is advised prior to use.

For adolescents and children aged 12 years and older, the recommended dosage is to apply a thin layer to the affected area 3 to 4 times daily.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, or safety concerns noted in the prescribing information for PainZone Light Cream. As such, healthcare providers may consider the standard dosing regimen for this population without the need for modifications based on age alone. However, it is advisable to monitor elderly patients for any unexpected responses to treatment, as individual variability may still occur.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in lactating women is also unclear. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or breastfeeding to avoid any potential adverse effects on fetal outcomes or infant health.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, the potential risks to nursing infants must be considered, and alternative treatments should be explored for lactating mothers.

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 consider the potential implications of excessive dosing.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdosage scenario. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to consult local poison control centers or relevant medical authorities for guidance on management protocols tailored to the specific situation.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management and follow-up care. Regular reassessment of the patient's condition is necessary to ensure appropriate therapeutic measures are implemented.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in nonclinical toxicology studies. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to avoid using the product on wounds or damaged skin, as well as not to apply it with a heating pad. It is important to inform patients that the product is not recommended for use in children under 12 years of age, and that pregnant or breastfeeding individuals should refrain from using it.

Patients should be instructed to stop using the product and consult a physician if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should seek medical advice if symptoms clear up and then recur within a few days, or if they experience excessive skin irritation.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a temperature range of 68 to 86 degrees Fahrenheit. The container must remain tightly closed to maintain the integrity of the product. Proper handling and storage conditions are vital to ensure the product's efficacy and safety.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin layer to the affected area 3-4 times daily for adults and children aged 12 years and older. 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 Painzone Light, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)