Menthol

Description

The product is identified by the National Drug Code (NDC) 71391-128-05 and is formulated as a menthol patch containing 7.5% natural menthol. This cooling pain relief patch is indicated for the alleviation of backaches, sore muscles, and joint pain. Each patch measures 5.51 inches by 3.94 inches (14 cm by 10 cm) and is designed for fast-acting cooling relief. The packaging includes a total of five patches.

Uses and Indications

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

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

Dosage and Administration

For adults and children over 12 years of age, the patch should be applied as follows: First, gently fold the patch in half and remove one side of the backing. The exposed adhesive should then be applied directly to the site of pain. After securing the patch in place, the remaining film should be removed to complete the application to the skin. The patch may be used on affected areas for a maximum duration of 12 hours.

For children 12 years of age or younger, it is essential to consult a doctor prior to use to determine appropriate dosing and administration.

Contraindications

The use of this product is contraindicated in the following situations:

• Co-administration with other creams, ointments, sprays, liniments, or topical products containing menthol is prohibited due to the potential for increased irritation or adverse effects.

• Contact with eyes and mucous membranes should be avoided to prevent irritation or injury.

• Application to wounds or damaged skin is contraindicated as it may exacerbate irritation or delay healing.

• Tight bandaging or the use of heating pads over the application site is not recommended, as this may increase the risk of adverse reactions.

Warnings and Precautions

For external use only. Prior to using this product, it is essential for individuals with sensitive skin to consult a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users should avoid contact with the eyes and mucous membranes, and the product must not be applied to wounds or damaged skin. Additionally, it is advised not to bandage the area tightly or apply a heating pad, as these actions may exacerbate irritation.

In the event of excessive irritation or redness, or if the condition worsens, it is crucial to discontinue use and seek medical advice. Users should also stop using the product if pain persists for more than 7 days or if symptoms resolve only to recur within a few days.

This product should not be used concurrently with other creams, ointments, sprays, liniments, or any topical products that contain menthol, as this may lead to increased irritation or adverse effects.

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

Side Effects

Patients should be aware that this product is intended for external use only. Prior to use, individuals with sensitive skin are advised to consult a healthcare professional. It is essential to use the product strictly as directed, avoiding contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and patients should refrain from tightly bandaging the area or using a heating pad in conjunction with the product.

In the event of excessive irritation or redness, or if the condition worsens, patients should discontinue use and seek medical advice. Additionally, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days, it is recommended to consult a healthcare provider.

Patients should not use this product in conjunction with other creams, ointments, sprays, liniments, or topical products that contain menthol. It is crucial to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Drug Interactions

Co-administration of this product with other topical formulations containing menthol, such as creams, ointments, sprays, or liniments, is contraindicated. The combination may lead to increased local irritation or adverse effects due to the cumulative action of menthol. It is advised to avoid using these products concurrently to ensure patient safety and minimize the risk of adverse reactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a doctor before use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in efficacy and safety profiles compared to older populations.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

The product has not specified any information regarding its use during pregnancy. There are no explicit warnings or contraindications mentioned for use during this period. Additionally, no dosage modifications for pregnant individuals are provided, and there are no special precautions listed regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients 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 prescribing information.

Overdosage

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

Prompt intervention 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product in conjunction with other creams, ointments, sprays, liniments, or any topical products that contain menthol, as this may lead to adverse effects. It is important to instruct patients to stop using the product and consult a doctor if they experience excessive irritation or redness, if their condition worsens, or if pain persists for more than 7 days. Additionally, patients should be advised to discontinue use and seek medical advice if symptoms resolve and then recur within a few days.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged skin. Patients should also be cautioned against tightly bandaging the area or using a heating pad while using this product. Furthermore, it is advisable for patients with sensitive skin to consult a doctor before using the product to ensure safety and efficacy.

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 in a cool and dry place to maintain its integrity. Care should be taken to protect the product from excessive moisture, as this can compromise its quality. Additionally, the product must not be refrigerated or frozen, as these conditions may adversely affect its efficacy. Proper handling and storage are crucial to ensure optimal performance and safety.

Additional Clinical Information

For adults and children over 12 years, the patch should be gently folded in half to remove one side of the backing, with the exposed adhesive applied to the site of pain. The remaining film should then be removed to complete the application to the skin. The patch can be used on affected areas for a duration of up to 12 hours. For children aged 12 years or younger, it is advised to consult a doctor prior to use.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)