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Muscle Rub

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Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 g/100 g
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 2025
Label revision date
February 12, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 g/100 g
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 2025
Label revision date
February 12, 2026
Manufacturer
Aldermed Inc.
Registration number
M017
NDC root
87236-005
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 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. This includes discomfort related to simple backaches, arthritis, strains, bruises, and sprains. It’s designed to help you feel more comfortable and get back to your daily activities.

Rest assured, there are no known 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 or your child is 2 years old or 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. However, if your child is under 2 years of age, it’s important to consult a doctor before using the medication. This will help ensure safety and effectiveness for younger children.

What to Avoid

It's important to be cautious when using this product. You should not apply it to wounds or damaged skin, as this could lead to complications. Always follow the instructions provided and consult with a healthcare professional if you have any questions or concerns about its use.

Side Effects

This product is intended for external use only, so please avoid applying it to wounds or damaged skin. While using it, be careful to keep it away from your eyes and do not wrap the area tightly with a bandage.

If your condition worsens, or if your symptoms last more than seven days or return after clearing up, stop using the product and consult a doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or any damaged skin. While using it, be careful not to let it come into contact with your eyes, and do not wrap the area tightly with a bandage.

If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

The product has not been evaluated for use during pregnancy, which means there is limited information on its safety for you and your developing baby. However, there are no specific warnings or contraindications mentioned regarding its use during this time. Additionally, you do not need to make any dosage modifications if you are pregnant, and no special precautions are indicated for using this product while pregnant.

As always, it's important to discuss any medications or products with your healthcare provider to ensure they are safe for you during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

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 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 treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 your overall treatment plan is safe and effective.

Always discuss any other medications, supplements, or health conditions you have, as this information is crucial for your safety and well-being. Your provider can guide you on how to manage your health effectively.

Storage and Handling

It's important to handle and store your product safely to ensure its effectiveness. First, always check that the seal on the tube is intact and visible before use; do not use it if the seal is damaged. To open the tube, simply unscrew the cap and pull the tab to remove the foil seal.

For storage, keep the product at room temperature, away from extreme heat or cold. Additionally, you can find the Lot Number and Expiry Date printed on the crimp of the tube or carton, so be sure to check these details to ensure you're using a product that is still valid.

Additional Information

No further information is available.

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 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What precautions should I take when using this product?

When using this product, avoid contact with eyes and do not bandage tightly. It is for external use only and should not be used on wounds or damaged skin.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms last more than 7 days or clear up and occur again within a few days.

What should I do if the product is swallowed?

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

Is this drug safe to use during pregnancy?

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

Can nursing mothers use this product?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this drug?

Store the drug at room temperature and do not use it if the seal on the tube is damaged or not visible.

Packaging Info

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

Packaging configurations for Muscle Rub.
Details

Drug Information (PDF)

This file contains official product information for Muscle Rub, 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 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 2 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 limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for adverse effects and impaired healing. No other contraindications have been specified in the provided data.

Warnings and Precautions

This product is intended for external use only and should not be applied to wounds or damaged skin. Healthcare professionals should advise patients to avoid contact with the eyes during application. Additionally, it is important to instruct patients not to bandage the area tightly after use to prevent complications.

Patients should be informed 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. These guidelines are essential for ensuring patient safety and effective treatment.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt action is crucial in such situations to mitigate potential health risks.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. When using this product, it is important to avoid contact with the eyes and to refrain from bandaging the area tightly.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur 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 assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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 Muscle Rub (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle Rub.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 evaluated for use during pregnancy. There are no specific warnings or contraindications associated with the use of this product in pregnant patients. Additionally, no dosage modifications are recommended for individuals who are pregnant. Furthermore, no special precautions are indicated for the use of this product during pregnancy. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the product is swallowed, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for further guidance and support.

Prompt intervention is essential to manage potential symptoms associated with overdosage effectively. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management procedures based on the severity of the 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin to prevent further complications.

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

While using the product, healthcare providers should emphasize the importance of avoiding contact with the eyes and advise against tightly bandaging the area where the product is applied. This guidance will help ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a tube format, with specific attention to the integrity of the seal. It is imperative that the product is not used if the seal on the tube is damaged or not visible. To access the product, the user should unscrew the cap and pull the tab to remove the foil seal.

Storage conditions require the product to be kept at room temperature. For traceability, the Lot Number and Expiry Date can be found on the crimp of the tube or on the carton.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Muscle Rub, 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 Muscle Rub, 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.