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Muscle Rub

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This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 0.01 mg/1 g
  • Methyl Salicylate 0.15 mg/1 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 2007
Label revision date
December 31, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 0.01 mg/1 g
  • Methyl Salicylate 0.15 mg/1 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 2007
Label revision date
December 31, 2024
Manufacturer
Natureplex LLC
Registration number
M017
NDC root
67234-002
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

Natureplex Ultra Strength MuscleRub is a topical product designed to temporarily relieve minor aches and pains in your muscles and joints. It can be particularly helpful for discomfort associated with simple backaches, arthritis, strains, bruises, and sprains.

This muscle rub works by providing temporary relief from these types of pain, making it a useful option for those seeking comfort from everyday muscle and joint issues.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for various conditions, including simple backache, arthritis, strains, bruises, and sprains. If you're dealing with any of these issues, this medication may help ease your discomfort and improve your mobility.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 12 years and older, you can apply it to the affected area up to four times a day.

For children under 12 years old, it's best to consult with a doctor before use to ensure safety and proper dosage. Always follow the guidance provided to achieve the best results.

What to Avoid

You should avoid using this product on wounds or damaged skin, and it is important not to apply it with a heating pad. If you are considering using it for a child under 12 years old with arthritis-like conditions, please refrain from doing so. Additionally, do not use the product if the seal on the tube is punctured or missing.

For your safety, do not bandage or wrap the area tightly after application, and make sure to keep it away from your eyes and mucous membranes. Following these guidelines will help ensure safe and effective use of the product.

Side Effects

This product is intended for external use only and should not be applied to wounds or damaged skin. Avoid using it with a heating pad and do not use it on children under 12 years old with arthritis-like conditions. If the seal on the tube is punctured or missing, do not use the product.

You should stop using this product and consult a doctor if you experience excessive skin irritation, if your condition worsens, or if symptoms persist for more than 7 days. Additionally, if symptoms improve and then return within a few days, seek medical advice. It's important to ask a doctor before using this product if the affected area is red, if you are pregnant or breastfeeding, or if you are considering use for children under 2 years old or for children up to 12 years old who may be sensitive to aspirin or salicylate. While using the product, avoid tightly bandaging the area and keep it away from your eyes and mucous membranes. Always keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Do not use it with a heating pad, and it is not suitable for children under 12 years old who have arthritis-like conditions. Make sure the seal on the tube is intact before use.

If you experience excessive skin irritation, if your condition worsens, or if symptoms persist for more than 7 days, stop using the product and consult your doctor. Additionally, if your symptoms improve and then return within a few days, reach out to your healthcare provider.

In case of accidental swallowing, seek emergency medical help immediately or contact a Poison Control Center at 800-222-1222. Always keep this product out of reach of children to ensure their safety.

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 800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, which can vary depending on the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using any medication. This is to ensure that it is safe for both you and your baby. Your healthcare provider can help you understand any potential risks and make informed decisions about your health and your baby's well-being. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when using this medication for children. If your child is under 12 years old and has arthritis-like conditions, you should not use this medication. For children younger than 2 years, it's essential to consult a doctor before use. Additionally, if your child is under 12 and has a history of allergic reactions to aspirin or salicylates (a group of chemicals related to aspirin), you should also seek medical advice.

For children aged 12 and older, you can apply the medication to the affected area up to four times a day. Always ensure you follow these guidelines to keep your child safe and healthy.

Geriatric Use

While there is no specific information about the use of this product in older adults, it is important to note that it is approved for use in adults and children aged 12 years and older. Since there are no dosage adjustments or special precautions mentioned for elderly patients, you can generally follow the standard dosing guidelines.

However, as with any medication, it’s always wise to consult with a healthcare provider to ensure it’s appropriate for your individual health needs, especially if you have any underlying health conditions or are taking other medications. Your healthcare provider can help you understand how this product may affect you or your loved ones.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action 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 may affect you if you have hepatic impairment (issues with liver function).

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 with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15 to 30°C (59 to 86°F). This temperature range helps maintain its effectiveness. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the product.

Handling the product safely is also important. Always ensure that you are in a clean environment to avoid introducing any unwanted substances. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this product only on the skin and apply it to the affected area up to four times a day if you are an adult or a child aged 12 years or older. If the user is under 12 years old, consult a doctor first. Remember, this product is for external use only, so avoid applying it to wounds or damaged skin, and do not use it with a heating pad.

Keep the product out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222. While using this product, do not wrap or bandage the area tightly, and be careful to avoid contact with your eyes or mucous membranes.

FAQ

What is Natureplex Ultra Strength MuscleRub used for?

Natureplex Ultra Strength MuscleRub is used to temporarily relieve minor aches and pains in muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I use Natureplex Ultra Strength MuscleRub?

You should apply the product to the affected area up to 4 times daily if you are an adult or a child 12 years old and older. For children under 12 years old, consult a doctor.

Are there any contraindications for using this product?

Do not use Natureplex Ultra Strength MuscleRub on wounds or damaged skin, with a heating pad, or on children under 12 years old with arthritis-like conditions.

What should I do if I experience excessive skin irritation?

If excessive skin irritation occurs, or if your condition worsens or symptoms persist for more than 7 days, stop using the product and ask a doctor.

Is it safe to use Natureplex Ultra Strength MuscleRub during pregnancy or breastfeeding?

You should ask a doctor before using this product if you are pregnant or breastfeeding.

What precautions should I take when using this product?

When using Natureplex Ultra Strength MuscleRub, do not bandage or wrap tightly, and avoid contact with your eyes or mucous membranes.

What should I do if the product is swallowed?

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

How should I store Natureplex Ultra Strength MuscleRub?

Store the product at 15 to 30°C (59 to 86°F) and make sure to close the cap tightly after use.

Packaging Info

Below are the non-prescription pack sizes of Muscle Rub (menthol and 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

Natureplex™ Ultra Strength MuscleRub is formulated for the relief of minor arthritis, backache, muscle, and joint pain. This topical preparation is presented in a net weight of 1.5 ounces (42.5 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in 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

Healthcare professionals should instruct patients to use the medication only as directed. For adults and children aged 12 years and older, the recommended application is to the affected area up to four times daily.

For children under 12 years of age, it is advised to consult a physician before use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended on wounds or damaged skin due to the potential for irritation and impaired healing. Application with a heating pad is contraindicated as it may increase the risk of burns or adverse reactions. The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population. Additionally, do not use if the seal on the tube is punctured or missing, as this may indicate contamination or compromised integrity.

Tight bandaging or wrapping of the area is not advised, as it may lead to increased pressure and potential complications. Contact with eyes or mucous membranes should be avoided to prevent irritation or injury.

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 on children under 12 years of age who present with arthritis-like conditions. The product must not be used if the seal on the tube is punctured or missing.

Healthcare professionals should advise patients to discontinue use and seek medical attention if excessive skin irritation occurs, if the condition worsens, or if symptoms persist beyond 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is warranted.

In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 800-222-1222.

It is imperative to keep this product out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on wounds or damaged skin, and should not be used in conjunction with a heating pad. Additionally, it is not recommended for children under 12 years old with arthritis-like conditions, and should not be used if the seal on the tube is punctured or missing.

Patients are advised to discontinue use and consult a doctor if excessive skin irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical advice should also be sought.

Before using this product, patients should consult a healthcare professional if the affected area is red, if they are pregnant or breastfeeding, or if the patient is a child under 2 years old. For children up to 12 years old, it is important to seek medical advice if they are prone to allergic reactions from or are sensitive to aspirin or salicylate.

While using this product, patients should avoid tightly bandaging or wrapping the area and should take care to prevent contact with the eyes or mucous membranes.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 800-222-1222.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Muscle Rub (menthol and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle Rub.
Details

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children under 2 years old, it is advised to consult a healthcare professional prior to use. Additionally, for children up to 12 years old, it is important to seek medical advice if they have a history of allergic reactions to aspirin or salicylates.

For those aged 12 years and older, the recommended application is up to four times daily to the affected area.

Geriatric Use

Elderly patients may be treated with this product, as it is indicated for adults and children aged 12 years and older. However, there is no specific information regarding geriatric use provided in the prescribing information. Consequently, healthcare providers should exercise caution when prescribing this product to geriatric patients, as individual responses may vary.

Given the absence of dosage adjustments or special precautions outlined for elderly patients, it is advisable for healthcare providers to closely monitor this population for any potential adverse effects or changes in efficacy. Regular assessment of the patient's clinical status is recommended to ensure optimal therapeutic outcomes.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay if the substance is ingested. The national Poison Control Center can be reached at 800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

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 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 at 800-222-1222.

Patients should be instructed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that this product should not be used on children under 12 years old who have arthritis-like conditions. Additionally, patients should be cautioned against using the product if the seal on the tube is punctured or missing.

Patients should be advised to stop using the product and consult a doctor if they experience excessive skin irritation, if their condition worsens, or if symptoms persist for more than 7 days. They should also be informed to discontinue use and seek medical advice if symptoms improve and then recur within a few days.

When using this product, patients should be instructed not to bandage or wrap the affected area tightly and to avoid contact with the eyes or mucous membranes. It is recommended that patients consult a doctor before use if the affected area appears red, if they are pregnant or breastfeeding, or if they are considering use for children under 2 years old. For children up to 12 years old, patients should seek medical advice if the child is prone to allergic reactions or is sensitive to aspirin or salicylates.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a temperature range of 15 to 30°C (59 to 86°F) to maintain its efficacy and stability.

After each use, the cap must be closed tightly to prevent contamination and ensure the integrity of the product. Proper adherence to these storage and handling guidelines is essential for optimal product performance.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of up to four times daily for adults and children aged 12 years and older. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients that the product is for external use only and should not be applied to wounds or damaged skin. It should not be used in conjunction with a heating pad. Patients must keep the product out of reach of children, and in the event of ingestion, they should seek medical assistance or contact a Poison Control Center immediately at 800-222-1222. Additionally, while using the product, patients should avoid tight bandaging or wrapping and prevent contact with eyes or mucous membranes.

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

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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.