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Mencylate

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Active ingredients
  • Menthol 20 mg/1 mL
  • Methyl Salicylate 100 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 1, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 20 mg/1 mL
  • Methyl Salicylate 100 mg/1 mL
Other brand names
Dosage form
Cream
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 2023
Label revision date
October 1, 2024
Manufacturer
PureTek Corporation
Registration number
M018
NDC root
59088-215
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

Mencylate™ is a medication designed to provide temporary relief from minor aches and pains in muscles and joints. It is commonly used for discomfort associated with simple backaches, arthritis, strains, bruises, and sprains. If you're experiencing any of these types of pain, Mencylate™ may help alleviate your symptoms and improve your comfort.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for various conditions, including simple backaches, arthritis, strains, bruises, and sprains.

You can rely on this treatment to ease discomfort and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of pain.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can apply this 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 their specific needs. Always follow your healthcare provider's advice for the best care.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should not apply it on wounds or damaged skin, and be careful not to bandage the area tightly. Additionally, make sure to avoid contact with your eyes or mucous membranes, as this can cause irritation. Always use the medication exactly as directed and do not use it for any purpose other than what is specified. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to wounds or damaged skin, and do not bandage tightly. Be cautious to keep it away from your eyes and mucous membranes, and use it only as directed.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult a doctor. Additionally, keep it out of reach of children; if 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, and do not bandage it tightly. While using this product, be careful to keep it away from your eyes and mucous membranes, and follow the directions provided.

If your condition worsens, or if your symptoms last more than 7 days or come back after clearing up, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

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 immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using Mencylate Pain Relieving cream during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best options for pain relief during this time. Always prioritize your health and the health of your baby by seeking professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Mencylate while nursing. Currently, there is no information available about whether this medication is passed into breast milk or if it poses any risk to your infant.

As always, it's a good idea to discuss any medications you are considering with your healthcare provider to ensure they are safe for you and your baby.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can apply the medication to the affected area up to 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use for your child.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). 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 for use and disposal to ensure safety and compliance.

Additional Information

For adults and children aged 12 and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Mencylate™ used for?

Mencylate™ 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 use Mencylate™?

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

Are there any contraindications for Mencylate™?

No specific contraindications are mentioned for Mencylate™.

What should I avoid while using Mencylate™?

You should not apply it on wounds or damaged skin, bandage tightly, or allow contact with the eyes or mucous membranes.

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

You should stop using Mencylate™ and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is Mencylate™ safe to use during pregnancy?

There is no specific information provided regarding the use of Mencylate™ during pregnancy.

Can nursing mothers use Mencylate™?

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

How should I store Mencylate™?

Store Mencylate™ at a controlled room temperature of 20°-25°C (68°-77°F).

What should I do if Mencylate™ is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Who manufactures Mencylate™?

Mencylate™ is manufactured in the USA by PureTek Corporation, located in Panorama City, CA.

Packaging Info

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

Packaging configurations for Mencylate.
Details

Drug Information (PDF)

This file contains official product information for Mencylate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Mencylate™ is a pharmaceutical product manufactured by PureTek Corporation, located in Panorama City, CA 91402. The product is effective as of March 30, 2023. For inquiries, a toll-free contact number is available at 1-877-921-7873.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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. It is important to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to application.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product is contraindicated for use in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation or adverse reactions. Tight bandaging is not recommended, as it may lead to compromised circulation. Contact with the eyes or mucous membranes should be avoided to prevent irritation or injury. Additionally, the product should only be used as directed; deviations from the recommended usage may result in unintended effects.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounds or damaged skin, and care should be taken to avoid bandaging tightly, as this may exacerbate potential adverse effects.

When utilizing this product, healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. It is crucial that the product is used strictly as directed to ensure safety and efficacy.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, this product should be kept 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 without delay.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid applying the product on wounds or damaged skin and to refrain from bandaging tightly. During use, contact with the eyes or mucous membranes should be avoided, and the product should not be used other than as directed.

In the event that the condition worsens, or if symptoms persist for more than 7 days or clear up and then occur again within a few days, patients are advised to stop use and consult a doctor. Additionally, this product should be kept out of reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Mencylate.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area not 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 Mencylate Pain Relieving cream during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before prescribing this medication to pregnant patients.

Lactation

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

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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to apply the product on wounds or damaged skin and to avoid tight bandaging of the area where the product is applied. It is important to inform patients that they should stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients should also seek medical advice.

While using this product, patients must be cautioned to avoid contact with the eyes or mucous membranes. Finally, healthcare providers should emphasize that the product should only be used as directed and not for any other purposes.

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 room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended that a clinician be consulted prior to 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 Mencylate, 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 Mencylate, 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.