Myderm Cooling Menthol Pain Relief with 50 Percent More Menthol

Description

myDerm Cooling Menthol Pain Relief Gel contains a formulation with 50% more menthol compared to standard products. This gel is designed for topical application to provide a cooling sensation and relief from pain. The increased menthol concentration enhances its efficacy in alleviating discomfort. The product is intended for use in managing localized pain and discomfort associated with various conditions.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. It is essential to wash hands with soap after each application to prevent unintentional contact with other areas of the body or surfaces.

For children under 2 years of age, it is recommended to consult a healthcare professional prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities over raw surfaces or blistered areas is not recommended due to the potential for increased irritation and adverse effects. Additionally, tight bandaging or the application of local heat, such as heating pads, to the area of use is contraindicated, as it may exacerbate irritation or lead to increased absorption of the product. Contact with eyes and mucous membranes should be avoided to prevent irritation and potential injury.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, redness appears, irritation develops, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought. These precautions are essential to ensure the safe and effective use of the product.

Side Effects

Patients using this product should be aware that it is intended for external use only. In clinical practice, participants are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, it is recommended that patients seek medical advice. These precautions are essential to ensure the safety and well-being of individuals using the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Myderm Cooling Menthol Pain Relief with 50 Percent More Menthol (menthol). 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, it is advised to consult a doctor prior to use.

Healthcare professionals should ensure that the product is 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 is recommended.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. Currently, there are no specific studies available regarding the effects of menthol on fetal development, and therefore, the potential risks to the fetus remain undetermined.

No specific dosage modifications for pregnant women are provided; healthcare professionals should be consulted for guidance on appropriate use. It is essential to use this product only as directed and to seek advice from a healthcare provider for any concerns regarding its use during pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment may necessitate a reduced dose of the medication. It is essential for healthcare professionals to monitor creatinine clearance in these patients to ensure appropriate dosing. Regular renal function tests should be performed in patients with kidney problems to assess their condition. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with the medication.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Rare cases of serious burns have been reported in postmarketing experience with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult their doctor if their condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days. They should also be cautioned to seek medical advice if symptoms clear up and then recur within a few days.

It is important to emphasize that the product should not be used in large quantities over raw surfaces or blistered areas. Patients must use the product only as directed and should read and follow all directions and warnings on the label. Providers should inform patients that rare cases of serious burns have been reported with products of this type. Additionally, patients should be advised not to bandage the area tightly or apply local heat, such as heating pads, to the area of use, and to avoid using the product in conjunction with a medicated patch. Finally, patients should be warned to avoid contact with eyes and mucous membranes.

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

Patients should apply the topical medication to the affected area no more than 3 to 4 times daily. It is important for patients to use the product only as directed and to read and follow all directions and warnings on the label. Clinicians should inform patients of the rare occurrence of serious burns associated with similar products and advise against tightly bandaging the area of application, applying local heat (such as heating pads), or using the product in conjunction with a medicated patch.

Patients should avoid contact with eyes and mucous membranes. They are advised to discontinue use and consult a doctor if the condition worsens, if redness or irritation develops, if symptoms persist for more than 7 days, or if symptoms clear up and recur within a few days. Additionally, the medication should be kept out of reach of children, and if swallowed, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Myderm Cooling Menthol Pain Relief with 50 Percent More Menthol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)