Medfreeze Naturally Cool Pain Relief

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, strains, and sprains.

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 dosage is to spray the medication on the affected area no more than 3 to 4 times daily. It is essential to shake the container well before each use to ensure proper dispersion of the formulation.

For children under 2 years of age, it is advised to consult a physician prior to administration to determine the appropriate course of action.

Contraindications

The product is contraindicated for use in conjunction with heating pads or devices, as this may lead to excessive heat and potential skin damage. It should not be applied alongside ointments, creams, sprays, or liniments, as these may alter the product's efficacy or cause adverse reactions. Application on wounds, damaged skin, or irritated skin is contraindicated due to the risk of exacerbating the condition or causing further irritation.

During use, it is essential to avoid contact with eyes or mucous membranes to prevent irritation or injury. Additionally, tight bandaging is not recommended, as it may impede circulation and lead to complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame. Users should avoid spraying the product in the eyes. The contents are under pressure; hence, the container should not be punctured or incinerated. It is crucial to store the product at temperatures not exceeding 120°F (48°C).

General precautions should be observed prior to use. Individuals with sensitive skin or those who are pregnant or breastfeeding are advised to consult a healthcare professional before using this product.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should discontinue use and contact their healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then reoccur within a few days, or if irritation develops.

No specific laboratory tests are required for monitoring during the use of this product.

Side Effects

Patients using this product should be aware of several important safety considerations. It is advised to stop use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to reoccur within a few days. Additionally, if irritation develops, medical advice should be sought.

Before using this product, patients should consult a doctor if they have sensitive skin or are pregnant or breastfeeding. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flames. Patients should avoid spraying the product in the eyes and should be aware that the contents are under pressure. The container should not be punctured or incinerated, and it should not be stored at temperatures above 120°F (48°C).

Patients are advised against using this product in conjunction with heating pads or devices, ointments, creams, sprays, or liniments. It should not be applied to wounds, damaged skin, or irritated skin. While using this product, patients should avoid contact with eyes or mucous membranes and should not bandage the area tightly.

This product should be kept 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.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Medfreeze Naturally Cool Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years old should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to spray on the affected area no more than 3 to 4 times daily.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are 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, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 provided in the insert.

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 to inform patients that the product should not be used in conjunction with heating pads or devices, nor should it be applied alongside ointments, creams, sprays, or liniments.

Patients should be cautioned against using the product on wounds, damaged skin, or areas of irritated skin. They should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to reoccur within a few days. Additionally, patients should stop using the product and seek medical advice if they experience any irritation.

While using the product, patients must be reminded to avoid contact with their eyes or mucous membranes. They should also be advised not to bandage the area tightly after application. It is essential for patients with sensitive skin to consult a doctor before using the product. Furthermore, pregnant or breastfeeding patients should be encouraged to seek medical advice prior to use.

Storage and Handling

The product is supplied in a secure container designed to maintain its integrity. It is essential to store the product in a cool, dry place, ensuring that it is kept away from excessive heat or open flame. The storage temperature must not exceed 120°F (48°C) to preserve the product's efficacy. After each use, it is crucial to replace the cap to prevent contamination and maintain the quality of the product.

Additional Clinical Information

Patients should apply the spray to the affected area no more than 3 to 4 times daily. Clinicians should advise patients to avoid contact with eyes or mucous membranes and to refrain from tightly bandaging the treated area.

Drug Information (PDF)

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

View product document (PDF)