Menthol 6.5%

Description

This product contains 6.5% menthol and is formulated as an ultra-strength medicated patch designed for pain relief. The patch measures 5 ½ x 4 inches (14 x 10 cm) and is intended for application on the shoulders, arms, neck, and legs. It provides relief from sore muscles and arthritis pain through deep penetration without the mess associated with topical applications. The patch is designed to be comfortable and breathable, ensuring it stays securely in place during use.

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 advised to consult a doctor prior to use.

Contraindications

Use is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the risk of exacerbating the injury and delaying healing. The use of a heating pad concurrently is contraindicated as it may increase the risk of burns or skin irritation. Additionally, contact with eyes and mucous membranes should be avoided to prevent irritation or injury. Tight bandaging is also contraindicated, as it may restrict circulation and lead to further complications.

Warnings and Precautions

The 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. In cases of excessive skin irritation, medical consultation is also recommended.

It is imperative 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. Participants are advised to consult a healthcare professional prior to use 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. Excessive skin irritation is another reason to stop use and consult a healthcare provider.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol 6.5% (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 adverse effects or changes in therapeutic response, 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 risk to the fetus is 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 the potential risks to the fetus. No specific dosage modifications for pregnant women are provided.

Lactation

There are no specific warnings or recommendations regarding the use of Menthol 6.5% Patch in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Menthol in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function provided in the insert text. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed 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 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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 understanding of the potential toxicological profile in nonclinical settings.

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 discontinue use 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 advised to stop use and seek medical advice if they experience excessive skin irritation.

While using this product, patients should be cautioned to avoid contact with their eyes and mucous membranes. They should also be instructed not to bandage the area tightly. Furthermore, patients should be encouraged to consult a doctor before use if there is redness over the affected area.

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 at room temperature, ensuring that the temperature does not exceed 80°F (27°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Menthol 6.5%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)