Menthol 5%

Description

This medicated patch contains 5% menthol and is designed for the relief of back pain and stiffness. The patch is extra large, measuring 9 x 4 inches (22 x 10 cm), and is formulated to provide a comfortable and breathable experience. It adheres securely to the skin without being messy or greasy, ensuring ease of use during application.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backache, arthritis, sprains, strains, and bruises.

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

Dosage and Administration

Adults and children 12 years of age and older should apply the patch to the affected area no more than 3 to 4 times daily.

To administer, open the pouch and remove the patch. Peel off the protective film and apply the sticky side directly to the affected area.

For children under 12 years of age, it is recommended to consult a doctor prior to use.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, the application of a heating pad in conjunction with this product is not recommended, as it may exacerbate skin reactions.

During use, it is essential to avoid contact with eyes and mucous membranes to prevent irritation. Furthermore, tight bandaging should be avoided to ensure proper circulation and to minimize the risk of adverse effects.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad.

Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes and mucous membranes. Additionally, patients should be instructed not to apply tight bandages over the treated area.

Patients must be informed to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. They should also stop use if excessive skin irritation occurs.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. Prior to use, patients are advised to consult a healthcare professional if there is any redness over the affected area.

During the use of this product, it is important to avoid contact with the eyes and mucous membranes. Additionally, patients should refrain from tightly bandaging the treated area.

Patients are instructed to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if excessive skin irritation occurs, patients should stop using the product and consult a healthcare provider.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol 5% (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

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

The safety of this product during pregnancy has not been established. There are no adequate and well-controlled studies in pregnant women; therefore, the potential risks to the fetus remain unknown. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use.

Use during pregnancy should only be considered if clearly needed, and the potential benefits must justify any potential risks to the fetus. No specific dosage modifications for pregnant women are provided; healthcare professionals should be consulted for guidance regarding use in this population.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on the nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of guidance 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 is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to counsel patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, patients should be made aware to discontinue use and seek medical advice if they experience excessive skin irritation. While using the product, patients should be cautioned to avoid contact with eyes and mucous membranes, and to refrain from bandaging the area tightly. Lastly, patients should be encouraged to ask a doctor before use if there is any redness over the affected area.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Menthol 5%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)