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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
February 5, 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
February 5, 2026
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-096

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Drug Overview

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

When applied to the skin, menthol works by creating a cooling sensation that helps to distract your body from pain, providing a soothing effect to the affected areas. This makes it a useful option for managing discomfort from everyday injuries or chronic conditions.

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 comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

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. This will help ensure that the treatment is safe and appropriate for younger patients. Always follow your healthcare provider's advice regarding dosage and application.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only apply it externally and avoid using it on wounds, damaged skin, or with a heating pad. If you are under 12 years old and have arthritis-like conditions, do not use this product. If you notice any redness in the affected area, consult your doctor before use. While using the product, 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 consult a doctor. Additionally, if the product is swallowed, seek medical help or contact a Poison Control Center immediately.

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 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 too much of a medication, it’s important to seek medical help right away. You can contact a Poison Control Center for guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help immediately. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

Currently, there is no information available about the use of 2.5% Menthol Pain Relief Gel 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, 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 use.

For those aged 12 and older, you can apply the medication to the affected area, but be sure to limit applications 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 for personalized advice. 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 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 tests to ensure your liver is functioning well while you are on medication. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 daily 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 temporarily relieves minor aches and pains of muscles and joints associated with 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 of age, 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 years of age with arthritis-like conditions.

What should I do if I accidentally swallow 2.5% Menthol Pain Relief?

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

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.

Is there any information about using this product during pregnancy?

There is no specific information regarding the use of 2.5% Menthol Pain Relief during pregnancy, so consult a healthcare professional.

Can nursing mothers use this product?

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

What is the storage requirement for 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 specified 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

Use is contraindicated in children due to the risk of accidental ingestion. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Side Effects

Patients using this product should be aware that it is for external use only and must not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad or on children under 12 years of age with arthritis-like conditions.

During the use of this product, patients are advised to avoid contact with eyes or mucous membranes and to refrain from tightly bandaging the area of application. If patients experience worsening of their condition or if symptoms persist for more than 7 days, they should discontinue use and consult a doctor. Furthermore, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with the use of 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of 2.5% Menthol Pain Relief Gel during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should consider this lack of data when prescribing this medication to pregnant patients. The potential risks to fetal outcomes remain undetermined due to the absence of clinical or animal studies addressing the effects of this product during pregnancy. Women of childbearing potential should be advised to discuss their options with their healthcare provider.

Lactation

Nursing 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance 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 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 considered as part of standard clinical practice.

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 assess the situation thoroughly and initiate appropriate management procedures based on the specific circumstances and symptoms presented.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

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 efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's integrity.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, it should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor regarding the application. 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 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.

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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.