Menthol Pain Relief Gel-Patch

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of muscle soreness and minor joint pains affecting the wrist, knees, back, neck, hips, shoulders, and elbows.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children over 12 years of age, the affected area should be cleaned and dried prior to application. The protective film should be torn off, and the exposed part of the patch should be applied directly to the affected area. While applying, it is important to carefully remove the remaining film while pressing the patch firmly onto the skin. The patch should be removed from the skin after a maximum application duration of 8 hours.

For children under the age of 12, it is recommended to consult a healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin due to the potential for irritation and adverse reactions. Additionally, concurrent use with heating pads or devices is contraindicated, as this may increase the risk of burns or skin damage. The application of this product alongside other ointments, creams, sprays, or liniments is also prohibited, as it may lead to unpredictable interactions or enhanced side effects. Lastly, individuals with known allergies to any of the product's ingredients must avoid its use to prevent allergic reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin. It should not be used in conjunction with heating pads or devices, nor should it be combined with other ointments, creams, sprays, or liniments. Individuals with known allergies to any ingredients in this product should refrain from use.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any skin reactions occur, including but not limited to redness, swelling, blistering, or other discomfort. Additionally, if symptoms persist beyond 7 days, patients should be instructed to consult a physician.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if they experience skin reactions such as redness, swelling, blistering, or other discomfort. Additionally, if symptoms persist for more than 7 days, medical advice should be sought.

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as this may lead to adverse effects. Additionally, it should not be used concurrently with other topical formulations, including ointments, creams, sprays, or liniments, to avoid potential interactions that could compromise efficacy or safety.

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

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 the age of 12 should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the affected area should be cleaned and dried prior to application. The protective film should be torn off, and the exposed part of the patch applied to the affected area. The remaining film should be carefully removed while pressing the patch firmly onto the skin. The patch should be removed after a maximum application time of 8 hours.

Geriatric Use

Elderly patients do not have specific geriatric use considerations, dosage adjustments, safety concerns, or special precautions associated with the use of Menthol Pain Relief Gel-Patch as indicated in the prescribing information. Therefore, healthcare providers may administer this product to geriatric patients without the need for modifications or additional monitoring specific to this population. However, as with all medications, it is advisable to consider the overall health status and concurrent medications of elderly patients when recommending treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, 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 the safety of both the mother and the developing fetus.

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 medication 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, as the lack of detailed overdosage data necessitates a vigilant approach. Symptoms may vary 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 standard supportive measures, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

Additionally, it is recommended to contact a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the situation. Continuous assessment and supportive care are critical in managing any adverse effects that may occur as a result of an overdose.

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

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. In the event of skin reactions such as redness, swelling, blistering, or other discomfort, it is recommended to discontinue use and seek medical advice.

No additional information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

During postmarketing experience, skin reactions including redness, swelling, blistering, and other forms of discomfort have been reported. Additionally, there have been instances of symptoms persisting for more than 7 days. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact the Poison Control Center if the medication is swallowed accidentally. It is essential to emphasize the importance of using the medication only as directed to ensure safety and efficacy.

Patients should be informed to avoid contact with the eyes, mucous membranes, or any rashes, as this may lead to adverse reactions. Additionally, healthcare providers should instruct patients not to bandage the area tightly, as this could cause complications. Clear communication of these points will help ensure patient safety and proper use of the medication.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring it is kept in a cool, dry place to maintain its integrity. The product must be protected from light exposure to prevent degradation. Freezing is not permitted, as it may compromise the quality of the product. Additionally, it is important to discard any remaining product after opening to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the treatment is topical. For adults and children over 12 years of age, it is recommended to remove the patch from the skin after a maximum application time of 8 hours. 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)