Menthol

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is imprinted with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The tablets are supplied in bottles containing 100 units.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and over should begin by cleaning and drying the affected area prior to application. A single patch should be removed from its film and applied directly to the skin over the affected area. The recommended dosage is one patch at a time, with a maximum application frequency of 3 to 4 times daily. Each patch should be removed from the skin after a maximum duration of 8 hours.

For children under 12 years of age, 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 with a heating pad is prohibited due to the risk of exacerbating injury or causing further irritation. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients should not use it, as this may lead to severe adverse reactions.

While using the product, it is essential to avoid contact with the eyes, mucous membranes, or rashes to prevent irritation or adverse effects. Furthermore, tight bandaging is not recommended, as it may restrict circulation and lead to complications.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare providers should counsel patients to discontinue use and consult a physician if any of the following occur: localized skin reactions, including but not limited to rash, itching, redness, irritation, pain, swelling, or blistering; worsening of the condition; persistence of symptoms beyond 7 days; or recurrence of symptoms after initial resolution within a few days.

Prompt medical attention is essential if the product is swallowed, reinforcing the need for patients to be vigilant and proactive in seeking help in such situations.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if localized skin reactions occur, including rash, itching, redness, irritation, pain, swelling, or blistering. Additionally, if conditions worsen or if symptoms persist for more than 7 days, medical advice should be sought. Patients are also advised to stop use if symptoms clear up and then recur within a few days.

Pregnant or breastfeeding patients are encouraged to consult a healthcare professional prior to use.

Drug Interactions

No drug interactions have been identified for the product, indicating that it does not exhibit significant pharmacokinetic or pharmacodynamic interactions with other medications. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or enhanced monitoring are necessary when co-administering this product with other drugs or during laboratory testing.

Packaging & NDC

Below are the non-prescription pack sizes of Hot Cold Medicated Patches. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and therefore, caution is advised.

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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 in the available sections of the drug insert, healthcare professionals are advised to exercise caution when administering this medication.

Should an overdosage occur, it is essential to monitor the patient closely for any potential symptoms that may arise, although no specific symptoms have been documented in the current literature.

Management of overdosage should be supportive and symptomatic, as no antidote or specific treatment protocol is outlined. Healthcare providers are encouraged to implement standard emergency procedures, including the assessment of vital signs and supportive care as necessary.

In cases of suspected overdosage, it is recommended to contact a poison control center or seek expert consultation for further guidance on management strategies.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 a Poison Control Center if the product is swallowed. It is important to instruct patients to discontinue use and consult a doctor if they experience localized skin reactions, including rash, itching, redness, irritation, pain, swelling, or blistering.

Patients should be informed to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be cautioned to consult a healthcare professional if symptoms resolve and then recur within a few days.

When discussing the use of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be advised to avoid contact with the eyes, mucous membranes, or any rashes while using the product. It is also crucial to inform patients not to bandage the area tightly.

For patients who are pregnant or breastfeeding, healthcare providers should recommend consulting a health professional before using the product to ensure safety.

Storage and Handling

The product is supplied in configurations that ensure optimal handling and storage. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to direct sunlight, as this may compromise the integrity of the product. Additionally, the product must be protected from excessive moisture to maintain its quality and efficacy. Proper adherence to these storage conditions is crucial for preserving the product's intended use and effectiveness.

Additional Clinical Information

Patients should apply one patch at a time to the affected area, with a maximum frequency of 3 to 4 applications daily. Each patch should be removed from the skin after no more than 8 hours of application. Clinicians are advised to counsel patients to consult a health professional if they are pregnant or breastfeeding before use.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)