Myderm Cooling Menthol Pain Relief Roll-on with 50 Percent More Menthol

Description

myDerm Cooling Menthol Pain Relief Roll-On contains a formulation with 50% more menthol compared to standard products. This enhanced concentration of menthol is designed to provide effective pain relief through a cooling sensation upon application. The roll-on dosage form allows for targeted application to affected areas, facilitating ease of use and convenience in pain management.

Uses and Indications

This drug is indicated for the temporary relief of pain. There are no teratogenic effects associated with its use, and 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 irritation and adverse effects. 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. Additionally, contact with eyes and mucous membranes should be avoided to prevent potential harm or adverse reactions.

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: 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, medical advice should be sought.

This product should not be applied in large quantities to raw surfaces or blistered areas. It is essential to use the product strictly as directed, adhering to all instructions and warnings provided on the label.

While rare, there have been reports of serious burns associated with the use of similar products. Therefore, it is crucial to avoid tightly bandaging the area of application or applying local heat, such as heating pads, to the treated area. The use of this product in conjunction with a medicated patch is also not recommended.

Care should be taken to avoid contact with the eyes and mucous membranes to prevent irritation or injury.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days or resolve and then recur within a few days. These warnings are essential to ensure patient safety and to prevent potential complications associated with prolonged use or adverse reactions.

Drug Interactions

No drug interactions have been reported for the product. Additionally, there are no interactions identified between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Myderm Cooling Menthol Pain Relief Roll-on 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.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for 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 risk to the fetus remains undetermined. No specific dosage modifications are provided for pregnant individuals; however, it is essential to use the product only as directed. Healthcare professionals are advised to provide guidance regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

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

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 compound in these areas.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare professional if their condition worsens, if redness or irritation develops, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is important to inform patients not to use this product in large quantities over raw surfaces or blistered areas. When using this product, patients should be reminded to follow the directions and warnings on the label carefully. They should be made aware that rare cases of serious burns have been reported with similar products.

Patients should also be cautioned against bandaging the area tightly or applying local heat, such as heating pads, to the area of use. Additionally, they should avoid contact with eyes and mucous membranes to prevent irritation.

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, or using the product in conjunction with a medicated patch.

Patients are cautioned to avoid contact with eyes and mucous membranes. They should 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 immediate medical assistance should be sought if ingested.

Drug Information (PDF)

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

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