Menthol Pain Relief Gel-Patch

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. It is specifically effective for conditions related to arthritis, backache, strains, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug as per the available data.

Dosage and Administration

For adults and children aged 12 years and older, the affected area should be cleaned and dried prior to application. The protective film should be partially peeled back, allowing the exposed patch to be applied directly to the site of pain. The remaining film must be carefully removed while pressing the patch firmly against the skin. The patch should be left in place for a maximum duration of 8 hours. It is recommended that the patch not be applied to the affected areas more than 4 times daily. After use, hands should be washed thoroughly with cool water.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may lead to adverse effects. Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury. The application of the product to wounds or damaged skin is prohibited due to the risk of exacerbating the condition. Concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may alter the efficacy or safety profile of the product. Additionally, application to irritated skin is contraindicated to avoid further irritation or complications.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center without delay to ensure appropriate management.

Healthcare providers should counsel patients to discontinue use and seek medical advice if any of the following occur: burning discomfort, excessive skin irritation, worsening of the condition, or if symptoms persist beyond 7 days. Additionally, if symptoms resolve and then recur within a few days, patients should be advised to stop use and consult their physician.

Emergency medical help is crucial in cases of accidental ingestion. Prompt action, including contacting a Poison Control Center, is essential to mitigate potential risks associated with ingestion.

Side Effects

For external use only. Patients should stop use and consult a doctor if they experience burning discomfort or excessive skin irritation. Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought.

Patients with sensitive skin are advised to ask a doctor before using this product to ensure safety and minimize the risk of adverse reactions.

Drug Interactions

The use of this medication is contraindicated with other topical formulations, including ointments, creams, sprays, or liniments. Co-administration may lead to altered efficacy or increased risk of adverse effects due to overlapping mechanisms of action or compounded irritative effects.

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the affected area should be cleaned and dried before application. The protective film should be partially peeled back to expose the patch, which is then applied to the site of pain. The remaining film should be carefully removed while pressing the patch to the skin, and it should be left in place for up to 8 hours. The patch may be used on affected areas no more than 4 times daily. After application, hands should be washed with cool water.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested.

Patients should be instructed to discontinue use and consult a doctor if they experience burning discomfort, excessive skin irritation, or if their condition worsens. Additionally, they should be informed to seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients must be reminded to follow the directions provided and to avoid bandaging tightly or using it in conjunction with heating pads or devices. It is crucial to avoid contact with the eyes and mucous membranes, and patients should not apply the product to wounds or damaged skin. They should also refrain from using the product alongside other ointments, creams, sprays, or liniments, and should not apply it to irritated skin.

Patients should be advised to store the product in a cool, dry place, away from direct sunlight. Furthermore, it is important for patients with sensitive skin to consult a doctor before using the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, ensuring it is kept away from direct sunlight to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the affected area should be cleaned and dried before partially peeling back the protective film to apply the exposed patch to the site of pain. The remaining film should be carefully removed while pressing the patch to the skin, and it should be left in place for up to 8 hours. The patch may be used on affected areas no more than four times daily, and hands should be washed with cool water after use. For children under 12 years of age, consultation with a physician is recommended prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)