Menthol Overnight 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 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

The affected area should be cleaned and dried prior to application. For adults and children over 12 years of age, the protective film should be torn off, and the exposed part of the patch applied directly to the affected area. While applying the patch, the remaining film should be carefully removed, ensuring that the patch is pressed firmly against the skin. The patch should be removed after a maximum application time of 8 hours.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the potential for adverse reactions and impaired healing.

• Concurrent use with heating pads or devices is contraindicated, as this may increase the risk of burns or skin irritation.

• The product should not be used in conjunction with other ointments, creams, sprays, or liniments, as this may lead to unpredictable interactions or reduced efficacy.

• Individuals with known allergies to any ingredients in this product should refrain from use to avoid 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 forms of discomfort. Additionally, if symptoms persist beyond 7 days, patients should consult a physician.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

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

Co-administration of this medication with other topical formulations, including ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical products may lead to altered absorption, increased risk of local irritation, or diminished therapeutic efficacy. It is advised to avoid concurrent use to ensure optimal treatment outcomes and minimize potential adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol Overnight 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 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 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 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 potential adverse effects or changes in efficacy, 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 potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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 clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

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.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved. 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 use of the compound in these contexts.

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 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 effects. Additionally, healthcare providers should instruct patients not to bandage the area tightly, as this could cause complications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate 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 strictly prohibited, as it may compromise the quality of the product. Additionally, once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication 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 Overnight Pain Relief Gel-Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)