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Menthol

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Active ingredient
Menthol 0.01 g/100 mL
Other brand names
Dosage form
Paste
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
September 6, 2025
Active ingredient
Menthol 0.01 g/100 mL
Other brand names
Dosage form
Paste
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
September 6, 2025
Manufacturer
FlexiGo Inc
Registration number
M017
NDC root
85524-2510

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Drug Overview

Menthol is a compound commonly used for its soothing properties. It is often found in various over-the-counter products, such as topical ointments and cough drops, where it provides a cooling sensation that can help relieve minor aches and pains or soothe throat irritation.

While the specific pharmacological details of how menthol works are not provided, it is widely recognized for its ability to create a refreshing feeling, which can be beneficial in alleviating discomfort. You may encounter menthol in different forms, including liquid preparations in sizes like 50ml and 60ml.

Uses

It appears that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, please consult your healthcare provider.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It’s important to be cautious when using this medication. You should not use any over-the-counter (OTC) products alongside it, as this could lead to unwanted effects. If you experience any adverse reactions or if your symptoms do not improve, you should stop using the medication immediately and consult your healthcare provider for further guidance. Always prioritize your safety and well-being when managing your health.

Side Effects

It's important to be aware of potential side effects when taking this medication. Some individuals may experience serious reactions, including severe allergic responses (anaphylaxis), which require immediate medical attention. If you notice any unusual symptoms or if your condition worsens, you should stop using the medication and consult your healthcare provider.

Common side effects may occur, but they can vary from person to person. Always pay attention to how your body responds and communicate any concerns with your doctor to ensure your safety and well-being while using this medication.

Warnings and Precautions

It's important to be aware of potential risks when using this medication. While there are no specific warnings or precautions listed, you should always stay informed about how the medication affects you personally.

If you experience any unusual symptoms or side effects, it's crucial to stop taking the medication and consult your doctor for guidance. Regular check-ins with your healthcare provider can help ensure that the treatment is working effectively and safely for you. Always prioritize your health and seek professional advice whenever you have concerns.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it’s better to err on the side of caution and seek help.

Pregnancy Use

Currently, there is no information available about the use of Menthol paste during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use menthol paste without specific warnings or recommendations against it. Currently, there is no information available about whether menthol paste passes into breast milk or if it poses any risk to your baby. As always, if you have concerns or questions about using any product while nursing, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When it comes to using this medication in children, the information provided does not specifically address pediatric use. This means there are no recommended ages, dosage differences, or safety concerns outlined for children. As a parent or caregiver, it's important to consult with a healthcare professional for guidance on the appropriate use of this medication in younger patients. Always prioritize your child's safety and well-being by seeking expert advice.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about dosage or potential side effects with your doctor, as they can provide personalized guidance based on your health history and current medications.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), you should be closely monitored by your healthcare provider. Regular renal function tests are essential to ensure your kidneys are working properly and to help guide any necessary changes in your treatment.

For those with significant renal impairment, a reduced dose of medication is recommended to avoid potential complications. Always communicate with your healthcare team about your kidney health and any concerns you may have regarding your treatment.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 your treatment, discussing your full medical history and any other medications is crucial. This ensures that your healthcare provider can give you the safest and most effective care tailored to your needs. Always feel free to ask questions and share any concerns you might have.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed and protect it from light to maintain its effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Menthol?

Menthol is a drug, but specific details about its general description or pharmacological mechanisms are not provided.

What should I do if I need to stop using Menthol?

You should stop use and consult a healthcare professional if necessary.

Are there any warnings associated with Menthol?

No specific warnings are provided in the insert for Menthol.

Is Menthol safe to use during pregnancy?

There is no information regarding the safety of Menthol use during pregnancy.

Can I use Menthol while nursing?

There are no specific warnings or recommendations regarding the use of Menthol in nursing mothers.

What should I know about using Menthol if I have kidney problems?

If you have renal impairment, dosage adjustments may be necessary, and renal function should be monitored regularly.

How should I store Menthol?

Store Menthol at room temperature between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

What sizes of Menthol are available?

Menthol is available in 50ml and 60ml sizes, as indicated by package labels.

Packaging Info

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

Packaging configurations for Menthol.
Details

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)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

No specific dosage or administration information is provided in the text. Therefore, healthcare professionals are advised to refer to the relevant prescribing information or clinical guidelines for detailed instructions regarding dosage, administration routes, and techniques. It is essential to consider patient-specific factors and clinical judgment when determining the appropriate dosage and administration regimen.

Contraindications

Use of this product is contraindicated in patients who are self-medicating with over-the-counter (OTC) medications.

If the patient is currently using OTC medications, they should discontinue use immediately.

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this product. Additionally, no laboratory tests have been identified as necessary for monitoring during treatment.

Healthcare professionals are advised to remain vigilant and to consider the individual patient's health status and medical history when prescribing this medication. In the absence of specific emergency medical help instructions or guidance on when to discontinue use and consult a physician, practitioners should exercise clinical judgment and provide appropriate patient education regarding potential signs of adverse effects or complications.

It is essential to maintain open communication with patients regarding their treatment and to encourage them to report any unusual symptoms or concerns promptly.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions, although infrequent, may occur and warrant immediate medical attention.

Common adverse reactions reported in clinical trials include mild to moderate symptoms that generally resolve upon discontinuation of therapy. Participants in these trials exhibited a variety of reactions, which were monitored closely to assess the safety profile of the medication.

In the postmarketing experience, additional adverse reactions have been reported, underscoring the importance of ongoing surveillance and patient reporting. It is crucial for patients to be aware of these potential reactions and to consult healthcare professionals if they experience any concerning symptoms.

Patients are advised to stop using the medication and seek medical advice if they encounter any serious adverse reactions or if common reactions persist or worsen. This precaution is essential to ensure patient safety and to facilitate appropriate management of any adverse effects.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Menthol.
Details

Pediatric Use

Pediatric use has not been specifically addressed in the provided text. There are no recommended ages, dosing differences, safety concerns, or special precautions for children mentioned. Therefore, healthcare professionals should exercise caution when considering the use of this medication in pediatric patients, as the efficacy and safety profile in this population remains undefined.

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.

Pregnancy

There is no information available regarding the use of Menthol paste during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals should consider this lack of data when advising pregnant patients or women of childbearing potential regarding the use of this product. It is recommended that the potential risks and benefits be carefully weighed before prescribing Menthol paste to this population.

Lactation

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

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. For patients with significant renal impairment, a reduced dose is recommended to mitigate potential risks associated with inadequate drug clearance.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical attention is warranted. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and a detailed medical history.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

  3. Decontamination: If appropriate and within a reasonable time frame, consider decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered according to established protocols.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on managing overdose cases effectively. Continuous monitoring and supportive care are critical components of managing patients with suspected overdosage.

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 keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should not use the product if they have a known allergy to any of its ingredients, as this could lead to serious adverse reactions.

Patients should be instructed to stop using the medication and consult a healthcare professional if their symptoms worsen or persist for more than 7 days. This guidance is crucial to ensure that patients receive appropriate care and avoid potential complications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at room temperature, within the range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. It is important to note that the product should be discarded after opening to maintain safety and efficacy.

Additional Clinical Information

No further data are available.

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)

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 Menthol, 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.

Learn more in our Editorial Policy

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.