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2.5% Menthol Pain Relief

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Active ingredient
Menthol, Unspecified Form 25 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2026
Label revision date
January 9, 2026
Active ingredient
Menthol, Unspecified Form 25 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2026
Label revision date
January 9, 2026
Manufacturer
Universal Distribution Center LLC
Registration number
M017
NDC root
52000-440

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Drug Overview

2.5% Menthol Pain Relief is a topical medication designed to temporarily relieve minor aches and pains in muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains.

The active ingredient, menthol, works by creating a cooling sensation on the skin, which can help distract from pain and discomfort. If you're experiencing minor muscle or joint pain, this product may provide the relief you need.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your mobility.

It's important to note that there are no reported 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

If you are an adult or a child aged 12 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 12 years of age, it’s important to consult a doctor before use. They can provide specific advice tailored to your child's needs. Always follow the recommendations given by your healthcare provider for safe and effective use.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care if the medication is swallowed. In such a case, seek medical help or contact a Poison Control Center immediately. Your safety is paramount, so always follow these guidelines closely.

Side Effects

When using this product, you should be aware of some important safety information. It is meant for external use only and should not be applied to wounds or damaged skin. Avoid using it with a heating pad and do not use it on children under 12 years of age who have arthritis-like conditions. If you notice any redness in the affected area, consult a doctor before use.

While using the product, make sure to keep it away from your eyes and mucous membranes, and avoid wrapping the area tightly. If your condition worsens, symptoms last longer than 7 days, or if you experience excessive skin irritation, stop using the product and seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. It should not be used with a heating pad or on children under 12 years old who have arthritis-like conditions. If you notice any redness in the area where you plan to use the product, consult your doctor before proceeding.

While using this product, be careful to keep it away from your eyes and mucous membranes, and do not wrap the area tightly with a bandage. If your condition worsens, symptoms last longer than 7 days, or if you experience excessive skin irritation, stop using the product and contact your doctor. Additionally, if symptoms improve and then return within a few days, reach out to your healthcare provider. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help or contact a Poison Control Center immediately. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Remember, it’s always better to be safe and get professional advice if you think an overdose has occurred. Don’t hesitate to reach out for help.

Pregnancy Use

The product has not been specifically studied for use during pregnancy, which means there is limited information on its safety for you and your developing baby. However, there are no explicit warnings or contraindications noted for using this product while pregnant. Additionally, you do not need to adjust the dosage if you are pregnant, and no special precautions are advised.

While the absence of warnings may seem reassuring, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

If your child is under 12 years old and has arthritis-like conditions, it's important not to use this medication. For children in this age group, you should consult a doctor before using it at all.

For those aged 12 and older, you can apply the medication to the affected area, but be sure to limit it to no more than 3 to 4 times a day. Always follow your healthcare provider's guidance to ensure safe and effective use.

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, it’s important to consult with a healthcare provider before starting the medication. 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. Always follow the recommended application guidelines for safe and effective treatment.

FAQ

What is 2.5% Menthol PAIN RELIEF used for?

2.5% Menthol PAIN RELIEF is used to temporarily relieve minor aches and pains of muscles and joints associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

How should I use 2.5% Menthol PAIN RELIEF?

Adults and children 12 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 12 years, consult a doctor.

Are there any warnings for using this product?

Yes, it is for external use only. Do not use on wounds or damaged skin, with a heating pad, or on children under 12 with arthritis-like conditions. Avoid contact with eyes and mucous membranes.

What should I do if I swallow this product?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Is 2.5% Menthol PAIN RELIEF safe to use during pregnancy?

The product has not been specifically evaluated for use during pregnancy, and there are no explicit warnings or contraindications mentioned.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before using this product, as there is potential for excretion in breast milk.

What should I do if my condition worsens or symptoms persist?

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

How should I store 2.5% Menthol PAIN RELIEF?

Store the product at 20° to 25°C (68° to 77°F).

Packaging Info

Below are the non-prescription pack sizes of 2.5% Menthol Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 2.5% Menthol Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for 2.5% Menthol Pain Relief, 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 drug.

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

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The application should be performed with clean hands, ensuring that the affected area is dry before application.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for use in children under 12 years of age who present with arthritis-like conditions.

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 or mucous membranes, and patients should refrain from tightly bandaging the area.

Patients must be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

This product should be stored out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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. Additionally, it is not recommended for children under 12 years of age who present with arthritis-like conditions.

Before using this product, patients are advised to consult a healthcare professional if there is any redness over the affected area. During use, it is important to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops.

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 2.5% Menthol Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 2.5% Menthol Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 product has not been specifically evaluated for use during pregnancy. There are no explicit warnings or contraindications associated with its use in pregnant patients. Additionally, no dosage modifications are recommended for individuals who are pregnant. Furthermore, no special precautions regarding the use of this product during pregnancy have been identified. Healthcare professionals should consider the lack of specific data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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, it is imperative to seek immediate medical assistance. If the substance is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to monitor the patient closely for any symptoms that may arise and to initiate appropriate management procedures based on the clinical presentation.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center if the medication is swallowed. This information is vital for ensuring patient safety and preventing potential harm.

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 a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

The medication is administered topically, with the recommended frequency for adults and children aged 12 years and older being 3 to 4 applications to the affected area daily. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for 2.5% Menthol Pain Relief, 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 2.5% Menthol Pain Relief, 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

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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.