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Toplast Cool Menthol 4percent

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This product has been discontinued

Active ingredient
Menthol 300 mg
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
July 28, 2020
Active ingredient
Menthol 300 mg
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
July 28, 2020
Manufacturer
Icure Pharmaceutical Inc, Wanju Factory
Registration number
part348
NDC root
73279-0014

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Drug Overview

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means that if you're experiencing discomfort from these issues, this drug may provide you with some much-needed relief.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're dealing with any of these issues, this medication may help alleviate your discomfort and improve your mobility.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

To use this medication, start by cleaning and drying the area of your skin that is affected. Once the skin is ready, peel the film off the patch and apply it directly to the clean skin. You can use one patch for a maximum of 12 hours.

If you are applying this medication for a child under 12 years old, it’s important to consult a physician (doctor) first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should take care to follow safety instructions.

If you accidentally swallow the medication, seek medical help immediately or contact a Poison Control Center. This step is crucial to ensure your safety and well-being. Always prioritize your health by using medications as directed.

Side Effects

When using this product, it's important to apply it only to the skin and avoid using it on wounds or damaged areas. If you have allergies to any ingredients, consult with a doctor or pharmacist before use. While using the product, make sure to follow all directions carefully, and avoid contact with your eyes, mucous membranes, or any rashes.

If you notice that your condition worsens, or if you develop a rash, itching, or excessive skin irritation, stop using the product and seek medical advice. Additionally, if your symptoms last more than seven days or come back shortly after treatment, it's best to consult a healthcare professional. If you are pregnant or breastfeeding, please check with a health professional before using this product.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Before using it, check with your doctor or pharmacist if you have any allergies to its ingredients. Always follow the instructions on the label carefully, and do not let it come into contact with your eyes, mucous membranes, or rashes. Avoid tightly bandaging the area or applying heat, like heating pads, to the treated area.

If your condition worsens, or if you experience a rash, itching, or excessive skin irritation, stop using the product and consult your doctor. Additionally, if your symptoms last more than 7 days or come back within a few days, seek medical advice. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult a physician (doctor) before using this medication. For children aged 12 and older, you can apply one patch, which can be worn for up to 12 hours. Always follow your healthcare provider's guidance to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any lab tests you undergo, as this helps in managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 68° to 77°F (20° to 25°C). It's important to keep it in a clean, dry location, away from direct sunlight and excessive moisture, as these conditions can affect its quality and safety.

When handling the product, always make sure your hands are clean to maintain its integrity. Avoid exposing it to environments that could introduce contaminants or moisture. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for temporary relief of minor aches and pains of muscles and joints associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

How should I use the patch?

For adults and children 12 years and over, clean and dry the affected area, peel the film from the patch, and apply it to the skin. Use 1 patch for up to 12 hours.

What should I do if I am under 12 years old?

If you are under 12 years of age, consult a physician before use.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it on wounds or damaged skin, and avoid contact with eyes and mucous membranes.

What should I do if I experience a rash or irritation?

Stop use and ask a doctor if your condition worsens, if rash, itching, or excessive skin irritation develops, or if symptoms persist for more than 7 days.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if the patch is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store the patch?

Store the patch at room temperature between 68° to 77°F (20° to 25°C) in a clean, dry place out of direct sunlight and protect it from excessive moisture.

Packaging Info

Below are the non-prescription pack sizes of Toplast Cool Menthol 4percent (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Toplast Cool Menthol 4percent.
Details

Drug Information (PDF)

This file contains official product information for Toplast Cool Menthol 4percent, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 12 years and over, the affected area should be cleaned and dried prior to application. A single patch should be peeled from its film and applied directly to the skin. The patch may be worn for a maximum duration of 12 hours.

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

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin. Prior to use, individuals should consult a healthcare professional if they have a known allergy to any active or inactive ingredients present in the formulation.

When utilizing this product, it is imperative to adhere strictly to the provided instructions. Users must read and follow all directions and warnings indicated on the label. Care should be taken to avoid contact with the eyes, mucous membranes, or any rashes. Additionally, it is advised not to apply tight bandages or local heat sources, such as heating pads, to the area of application.

Discontinuation of use and consultation with a healthcare provider is necessary if the condition worsens, if a rash, itching, or excessive skin irritation occurs, or if symptoms persist for more than seven days or reoccur within a few days.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional before using this product.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. Prior to use, individuals are advised to consult a doctor or pharmacist if they have a known allergy to any active or inactive ingredients.

When using this product, it is crucial to adhere strictly to the directions provided on the label. Users should avoid contact with the eyes, mucous membranes, or any rashes. Additionally, it is important not to bandage the area tightly or apply local heat, such as heating pads, to the site of application.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, development of a rash, itching, or excessive skin irritation, or if symptoms persist for more than seven days or reoccur within a few days. Furthermore, individuals who are pregnant or breastfeeding should consult a health professional before using this product.

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 for any emerging data regarding potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Toplast Cool Menthol 4percent (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Toplast Cool Menthol 4percent.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For adolescents aged 12 years and older, the recommended dosage is one patch applied for a duration of up to 12 hours.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 important to assess the potential risks and benefits associated with its use 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 no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for further assistance in managing potential overdosage situations. Continuous assessment and symptomatic treatment should be prioritized to ensure patient safety and well-being.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure patient safety and appropriate management of any potential risks associated with the ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ideally between 68° to 77°F (20° to 25°C). The storage area must be clean and dry, ensuring that the product is kept out of direct sunlight. Additionally, it is essential to protect the product from excessive moisture to maintain its integrity and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Toplast Cool Menthol 4percent, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Toplast Cool Menthol 4percent, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.