Menthol

Description

This product is available in multiple formulations, including 30 mL, 50 mL, 100 mL, 150 mL, and 200 mL containers, as well as a 227 mL option. The specific product codes for these formulations are as follows: 69980-102-01 for 30 mL, 69980-102-02 for 50 mL, 69980-102-03 for 100 mL, 69980-102-04 for 150 mL, 69980-102-05 for 200 mL, 69980-102-06 for another 30 mL, 69980-102-07 for another 50 mL, 69980-102-08 for another 100 mL, 69980-102-09 for another 150 mL, 69980-102-010 for another 200 mL, and 69980-102-011 for 227 mL. Each formulation is designed to meet specific dosing requirements.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older. It is recommended to apply a small amount to the affected area and massage gently, not exceeding four applications per day. Following application, it is advised to wash hands with cool water to prevent unintended contact with other areas.

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply a small amount of the product to the affected area and massage gently into the skin. This application should not exceed four times per day. Following application, it is advised to wash hands with cool water to prevent unintentional contact with other areas of the body or surfaces.

The product is intended for topical use only. Care should be taken to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Patients with a known allergy to any of the ingredients.

• Application on inflamed or broken skin around the eyes, due to the potential for exacerbation of irritation or adverse reactions.

• Concurrent use with other topical treatments under bandages or occlusive dressings, as this may increase the risk of systemic absorption and adverse effects.

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

Warnings and Precautions

The product is intended for external use only. In the event of ingestion, it is imperative to seek immediate medical assistance. Should a rash develop during use, the application must be discontinued promptly.

Healthcare professionals are advised to exercise caution and recommend that patients consult with their doctor or pharmacist prior to use if they have any of the following conditions: diabetes, pregnancy, breastfeeding, poor circulation, or any existing skin conditions. Additionally, if symptoms persist, it is essential for patients to seek further medical advice.

Monitoring for adverse reactions, particularly skin-related issues, is recommended to ensure patient safety during the use of this product.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of ingestion, it is imperative to seek medical assistance immediately. Should a rash develop during use, discontinuation of the product is advised.

Additionally, it is recommended that patients consult their doctor or pharmacist prior to use if they have any of the following conditions: diabetes, pregnancy, breastfeeding, poor circulation, or a pre-existing skin condition. Patients should also seek medical advice if symptoms persist.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources for any emerging data regarding potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Freeze Cooling Pain Relief. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under the age of 12 should not be administered this medication. Safety and efficacy have not been established in this age group, and use is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult their healthcare provider or pharmacist prior to using this medication, particularly if they have underlying conditions such as diabetes. The safety of this medication during pregnancy has not been established, and potential risks to fetal outcomes are not fully characterized. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances and any potential risks with their healthcare provider before initiating treatment.

Lactation

Lactating mothers should consult their doctor or pharmacist before using this medication, particularly if they are diabetic, pregnant, or breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals are advised to exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney 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 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 event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should be aware that prompt intervention is crucial in managing potential complications associated with overdosage.

Symptoms of overdosage may vary depending on the substance involved and the amount ingested. It is essential for healthcare providers to monitor the patient closely for any signs of adverse reactions or toxicity.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare professionals should assess the patient's condition and provide appropriate interventions based on the severity of symptoms. This may include monitoring vital signs, administering activated charcoal if indicated, and providing intravenous fluids or other supportive measures as necessary.

In all cases of suspected overdosage, consultation with a poison control center or toxicology expert is recommended to ensure optimal management and care.

Nonclinical Toxicology

There were no teratogenic effects observed in the studies conducted. Additionally, no non-teratogenic effects were reported. The nonclinical toxicology section did not provide any further details, and there were no findings related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult their doctor or pharmacist prior to using the medication if they have any of the following conditions: diabetes, pregnancy, breastfeeding, poor circulation, or a skin condition. It is also important to inform patients that they should seek medical advice if their symptoms persist despite treatment. This guidance is essential to ensure the safe and effective use of the medication.

Storage and Handling

The product is available in various package configurations, identified by their respective NDC numbers. Specific storage and handling instructions are not provided in the SPL text. Therefore, it is recommended that the product be stored in a manner consistent with standard pharmaceutical practices to ensure its integrity and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area, massaged gently, up to four times daily for adults and children aged 12 years and older. Patients are advised to wash their hands with cool water after application.

Clinicians should counsel patients to consult with their doctor or pharmacist prior to use if they have diabetes, are pregnant or breastfeeding, have poor circulation, or a skin condition, or if symptoms persist. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)