Menthol

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 relief of various types of pain, including rheumatic pain, joint pain, low back pain, neuralgia, muscle aches, sprains, and contusions.

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

Dosage and Administration

Before administration, healthcare professionals should ensure that the skin of the affected area is thoroughly cleaned. Following this, the protective film should be carefully peeled off. The patch must then be applied directly to the affected area for optimal efficacy.

Contraindications

Use is contraindicated in patients with open wounds on the skin. Additionally, the product should not be used in children. These contraindications are in place to prevent potential adverse effects associated with the application in these populations.

Warnings and Precautions

The product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product on areas of the skin that have open wounds, as this may lead to adverse effects or complications. Additionally, the use of this product is contraindicated in children, and healthcare providers should ensure that it is not applied to pediatric patients.

The recommended duration of use should not exceed 8 hours. Prolonged exposure beyond this timeframe may increase the risk of skin irritation or other adverse reactions. Healthcare professionals should monitor patients for any signs of irritation or sensitivity during and after the application period. Regular assessment of the application site is advised to ensure safety and efficacy.

Side Effects

Patients should be aware that the product is intended for external use only. It is important to adhere to the recommended usage guidelines, as prolonged application beyond 8 hours is not advised.

In clinical practice, participants should be monitored for any adverse reactions associated with the use of this product. If any unexpected effects occur, it is recommended to discontinue use immediately and consult a healthcare professional.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Knee Patch. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product if there are open wounds on the skin. It is essential to keep the product out of reach of children to prevent accidental ingestion or misuse. Healthcare professionals are advised to recommend that this product be stored in a secure location, such as a locker, above and away from children.

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

There is no information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no information available regarding the use of this drug in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when prescribing this medication to nursing mothers.

Renal Impairment

Patients with renal impairment may require dosage adjustments due to reduced renal function. It is essential to monitor renal function tests regularly in individuals with known kidney problems. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to ensure safety and efficacy.

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 attention should be sought. 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 if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of overdose, even in the absence of detailed information regarding specific overdosage effects.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

Postmarketing experience has indicated that this product may be associated with occasional skin allergies. Reports of erythema and edema due to skin irritation have been documented. In cases where these reactions occur, it is advised to discontinue use of the product immediately. Typically, the erythema and edema resolve spontaneously. If required, topical corticosteroids may be applied to the affected area for management of the skin allergy.

Patient Counseling

Healthcare providers should advise patients to store this product in a secure location, specifically in a locker that is above and out of reach of children, to prevent accidental exposure or ingestion.

Patients should be informed that the product is contraindicated for use on open wounds or in children. It is essential to emphasize that the duration of use should not exceed 8 hours to ensure safety and efficacy.

Additionally, healthcare providers should counsel patients to avoid engaging in strenuous activities while using this product, as this may affect its performance and the patient's overall safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. However, no specific storage or handling instructions are provided. It is recommended that healthcare professionals refer to standard storage practices for similar products to ensure optimal quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)