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Menthol

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Active ingredient
Menthol 5 g/100 1
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
January 31, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 5 g/100 1
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2026
Label revision date
January 31, 2026
Manufacturer
Henan Enokon Medical Instrument Co. , Ltd.
Registration number
M017
NDC root
83559-014
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to temporarily relieve minor pain associated with various conditions, including arthritis, simple backache, muscle strains, bursitis (inflammation of the bursa, a small fluid-filled sac), tendonitis (inflammation of a tendon), strains, bruises, and cramps.

If you're experiencing discomfort from any of these issues, this drug may help alleviate your pain and improve your comfort. Always consult with a healthcare professional for personalized advice and treatment options.

Uses

If you're dealing with minor pain, this medication can help provide temporary relief. It's effective for various conditions, including arthritis, simple backaches, muscle strains, bursitis (inflammation of the fluid-filled sacs that cushion your joints), tendonitis (inflammation of the tendons), and general strains or bruises. Additionally, it can alleviate cramps, making it a versatile option for managing discomfort.

Whether you're experiencing pain from an injury or chronic conditions, this medication is designed to help you feel better and get back to your daily activities. Always consult with a healthcare professional if you have any questions about your pain management options.

Dosage and Administration

To use this medication, start by peeling off the protective backing from the patch. Then, apply the sticky side directly to the affected area of your skin. Make sure to carefully remove the backing from the patch before applying it. You can wear the patch for up to 8 hours, and it’s important not to use it more than 3 to 4 times in a single day.

If you are considering this medication for a child under 12 years old, it’s essential to consult a doctor first to ensure it’s safe and appropriate for them. Always follow these guidelines to ensure effective and safe use of the patch.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not bandage the area tightly or use a heating pad while using this product. Additionally, make sure to avoid contact with your eyes and mucous membranes, as this can cause irritation. Do not apply the medication to any wounds or damaged skin, as this could lead to complications.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

For your safety, this product is intended for external use only. If you notice that your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, it's important to stop using the product and consult a doctor. Additionally, if you experience any redness or skin irritation, you should also seek medical advice.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product to ensure it is safe for you.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. Keep it out of reach of children, and if it is swallowed, seek medical help right away or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days. Additionally, if you notice any redness or develop skin irritation, it's important to consult your doctor.

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

If you are pregnant or breastfeeding, it’s important to consult with your healthcare provider before using this medication. They can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your doctor regarding your health and any medications you may be considering during this time.

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 doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional advice when it comes to their health.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

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 feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 68°F and 77°F (20°C to 25°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, using it for up to 8 hours at a time, and no more than 3 to 4 times a day. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product.

Make sure to keep it out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center at 1-800-222-1222 right away.

FAQ

What is this drug used for?

This drug is indicated to temporarily relieve minor pain associated with conditions such as arthritis, simple backache, muscle strains, bursitis, tendonitis, strains, bruises, and cramps.

How should I use this drug?

For adults and children 12 years and older, peel off the protective backing and apply the sticky side to the affected area. It should be used for up to 8 hours and no more than 3 to 4 times daily.

Are there any contraindications for this drug?

No specific contraindications are mentioned in the provided information.

What precautions should I take when using this drug?

Use only as directed, avoid bandaging tightly or using with a heating pad, and do not apply to wounds or damaged skin. Also, avoid contact with eyes and mucous membranes.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, redness is present, or skin irritation develops.

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

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

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center immediately at 1-800-222-1222.

How should I store this drug?

Store the drug at room temperature between 68° to 77°F (20° to 25°C).

Is this drug safe for children under 12?

Children under 12 years of age should consult a doctor before use.

Packaging Info

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

Packaging configurations for Cold and Hot Medicated Patch.
Details

Drug Information (PDF)

This file contains official product information for Cold and Hot Medicated Patch, 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 pain associated with various conditions, including arthritis, simple backache, muscle strains, bursitis, tendonitis, strains, bruises, and cramps.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 12 years and older, the patch should be applied to the affected area after carefully removing the backing. The protective backing must be peeled off, and the sticky side of the patch should be affixed to the skin. Each patch is intended for use for a maximum duration of 8 hours. It is recommended that the patch be applied no more than 3 to 4 times within a 24-hour period.

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:

Tight bandaging or application with a heating pad is not recommended, as this may lead to adverse effects. Contact with eyes and mucous membranes should be avoided to prevent irritation or injury. Additionally, application to wounds or damaged skin is contraindicated due to the risk of exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. This product is not intended for internal consumption.

Healthcare professionals should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or skin irritation develops.

In cases of ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, individuals should seek medical advice if redness is present or if skin irritation develops.

Pregnant or breastfeeding patients should consult a health professional before using this product.

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 Cold and Hot Medicated Patch. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Hot Medicated Patch.
Details

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 before using this medication. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The prescribing information does not specify risk categories or provide detailed data from clinical or animal studies regarding fetal outcomes. Therefore, healthcare providers are advised to evaluate individual circumstances and consider alternative treatments if necessary.

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 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center for guidance on management strategies tailored to the specific situation. Continuous assessment of the patient's clinical status is essential to ensure appropriate interventions are implemented promptly.

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, if redness is present, or if skin irritation develops.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use it in conjunction with a heating pad. Additionally, patients should avoid contact with their eyes and mucous membranes and should not apply the product to wounds or damaged skin.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a health professional before using the product.

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 room temperature, maintaining a range of 68° to 77°F (20° to 25°C) to ensure its stability and efficacy. Proper storage conditions must be adhered to, as deviations from the recommended temperature range may affect the product's quality.

Additional Clinical Information

The product is administered topically and should be applied for a maximum of 8 hours, not exceeding 3 to 4 applications per day. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cold and Hot Medicated Patch, 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 Cold and Hot Medicated Patch, 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.