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Menthozen Cream

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Active ingredients
  • Menthol, Unspecified Form 50 mg/1 mL
  • Capsaicin 0.375 mg/1 mL
  • Methyl Salicylate 200 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
January 1, 2026
Active ingredients
  • Menthol, Unspecified Form 50 mg/1 mL
  • Capsaicin 0.375 mg/1 mL
  • Methyl Salicylate 200 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
January 1, 2026
Manufacturer
Village Pharma LLC
Registration number
M017
NDC root
71574-605

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Drug Overview

This medication is designed to provide temporary relief from minor aches and pains in muscles and joints. It can be helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from these common issues, this drug may be a suitable option to consider for alleviating your pain.

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 discomforts, this medication may help ease your symptoms and improve your comfort.

Dosage and Administration

If you are an adult or a child who is at least two years old, you can apply this medication to the affected area up to three to four times a day. Make sure to follow this guideline to ensure the best results.

If your child is under two years old, it’s important to consult a physician (doctor) before using this medication. They can provide the best advice on how to proceed safely.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should avoid applying it to any wounds or damaged skin, as this can lead to complications. Additionally, be careful not to bandage the area tightly after application, as this may cause discomfort or hinder proper healing.

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

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, and if your condition worsens or symptoms last more than seven days, stop using it and consult a physician. Keep it out of reach of children, and if swallowed, seek medical advice immediately. Do not apply it to wounds or damaged skin, and avoid wrapping the area tightly.

If you are pregnant or breastfeeding, please contact your physician before using this product to ensure it is safe for you.

Warnings and Precautions

This product is intended for external use only, so please avoid getting it in your eyes. If you notice that your condition worsens, or if your symptoms last longer than seven days or return after improvement, stop using the product and consult your doctor.

It's important not to apply this product to any wounds or damaged skin, and avoid wrapping the area tightly after application. If you accidentally swallow the product, seek medical advice immediately. If you are pregnant or breastfeeding, please talk to your doctor before using this product.

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 an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby remain safe. Always prioritize open communication with your physician regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to talk to your doctor before using this medication. Consulting with a healthcare professional can help ensure that you and your baby remain safe and healthy while considering any potential risks associated with the medication. Always prioritize open communication with your physician regarding your breastfeeding journey.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged two years and older, you can apply it to the affected area up to three to four times a day. However, if your child is under two years old, you should consult a physician (doctor) before using the medication to ensure it's safe for them.

Always make sure to monitor your child's response to the treatment and reach out to a healthcare professional if you have any concerns or questions about their care.

Geriatric Use

While there is no specific information about the use of Menthozen Cream in older adults, it's always important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this cream. They can provide personalized advice based on your health needs and any other medications you may be taking. Always prioritize your safety and well-being when considering new treatments.

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 treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 determine the best approach based on your liver function and overall health.

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 room temperature. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

For adults and children aged two years and older, you should apply the medication to the affected area no more than three to four times a day. If the patient is under two years of age, it's important to consult a physician before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the primary use of this drug?

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

How should I apply this drug?

Adults and children two years of age or older should apply it to the affected area no more than three to four times daily. For children under two years of age, consult a physician.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

What precautions should I take when using this drug?

For external use only, avoid contact with the eyes, and do not apply to wounds or damaged skin. If symptoms worsen or persist for more than seven days, discontinue use and consult a physician.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, contact a physician prior to use.

How should I store this drug?

Store the drug at room temperature.

What should I do if this drug is swallowed?

If swallowed, consult a physician immediately.

Packaging Info

Below are the non-prescription pack sizes of Menthozen Cream (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Menthozen Cream.
Details

Drug Information (PDF)

This file contains official product information for Menthozen Cream, 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 of muscles and joints associated with 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 two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, it should not be used with tight bandaging, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens, or if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued immediately, and a physician should be consulted.

In cases of accidental ingestion, it is essential to seek medical advice promptly. This product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, care should be taken not to bandage the area tightly, as this could impede circulation and lead to further complications.

For individuals who are pregnant or breastfeeding, it is crucial to consult a physician prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a physician.

It is crucial to keep this product out of reach of children. If swallowed, patients should seek medical advice immediately. Additionally, the product should not be applied to wounds or damaged skin, and it should not be bandaged tightly.

For pregnant or breastfeeding individuals, it is recommended to contact a physician prior to use to ensure safety and appropriateness of the product.

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 Menthozen Cream (methyl salicylate, menthol, capsaicin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Menthozen Cream.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of Menthozen Cream, including dosage adjustments, safety concerns, or special precautions. As such, 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

Pregnant patients and those who are breastfeeding should contact a physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

Lactating mothers are advised to contact a physician prior to using this medication. There is no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when considering this medication for lactating patients.

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 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 regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology studies. Additionally, no data has been provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to consult a physician immediately if the product is swallowed. It is important to emphasize that the product should not be applied to wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should be instructed not to bandage the area tightly after application, as this could interfere with the product's effectiveness and safety.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

Patients aged two years and older are advised to apply the medication to the affected area no more than three to four times daily. For children under two years of age, consultation with a physician is recommended prior to use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Menthozen Cream, 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 Menthozen Cream, 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.