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Ultra Strength Muscle Rub

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Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2021
Label revision date
December 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Camphor (synthetic) 40 mg/1 g
  • Methyl Salicylate 300 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 2021
Label revision date
December 17, 2024
Manufacturer
The Mentholatum Company
Registration number
M017
NDC root
10742-6000
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

Ultra Strength Muscle Rub is a topical treatment 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 product has been effective since December 14, 2020, providing support for those seeking relief from everyday muscle and joint pain.

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 it to ease discomfort from these common issues, allowing you to get back to your daily activities with less pain. Remember, while it can help with these specific conditions, it's always a good idea to consult with a healthcare professional if you have any concerns.

Dosage and Administration

When using this medication, you should apply it to the affected area of your skin no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. This helps ensure that you get the best results while minimizing the risk of side effects.

If you are considering using this medication for a child under 12 years old, it’s important to consult with a doctor first. They can provide guidance on the appropriate use and dosage for younger patients. Always follow these instructions carefully to ensure safe and effective treatment.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should never get it into your eyes or on mucous membranes, as this can cause irritation. Additionally, avoid applying it to wounds or damaged skin, and refrain from bandaging the area tightly. Using a heating pad or applying external heat while using this medication is also not recommended, as it can lead to unwanted effects.

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

When using this product, it's important to apply it only as directed and avoid contact with your eyes or mucous membranes. You should not use it on wounds or damaged skin, and be careful not to bandage the area too tightly or use it with a heating pad.

If you experience skin redness or excessive irritation, or if your condition worsens, you should stop using the product and consult a doctor. Additionally, if your symptoms persist for more than seven days or improve and then return shortly after, seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes. It's important to use it exactly as directed and not to apply it to wounds or damaged skin. Additionally, do not bandage the area tightly or use it with a heating pad or any external heat source.

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

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. Your safety is important, so please follow these guidelines carefully.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional 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 expert advice.

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 with a doctor before using this medication. For children aged 12 and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment 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, it’s important to consult with a healthcare provider before starting the medication. 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 is safe and effective, especially if you have any concerns about your kidney 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 (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 the 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 discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from excessive heat. It's important not to freeze the product, as this can affect its effectiveness. When you're not using the tube, make sure to keep it tightly closed to maintain its integrity. Remember to discard the product after opening to ensure safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. Always follow the recommended application guidelines for safe and effective treatment.

FAQ

What is Ultra Strength Muscle Rub used for?

Ultra Strength Muscle Rub temporarily relieves minor aches and pains of muscles and joints, including simple backache, arthritis, strains, bruises, and sprains.

How should I use Ultra Strength Muscle Rub?

Apply to the affected area not more than 3 to 4 times daily for adults and children 12 years and over. For children under 12 years, ask a doctor.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if I experience skin irritation?

Stop use and ask a doctor if skin redness or excessive irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days.

Can I use Ultra Strength Muscle Rub if I am pregnant or breastfeeding?

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

How should I store Ultra Strength Muscle Rub?

Store at room temperature, protect from excessive heat, and do not freeze. Keep the tube tightly closed when not in use.

What should I do if I accidentally swallow Ultra Strength Muscle Rub?

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

Packaging Info

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

Packaging configurations for Ultra Strength Muscle Rub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Ultra Strength Muscle Rub is a topical formulation designed for the relief of muscle and joint discomfort. It is presented in an ointment dosage form, characterized by its smooth texture and easy application. The product is formulated to provide targeted relief through its active ingredients, which penetrate the skin to alleviate pain. The appearance of the muscle rub is typically a semi-solid, opaque substance, suitable for direct application to affected areas.

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. The specific frequency of application should be determined based on the severity of the condition and the response to treatment.

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

Contraindications

Use of this product is contraindicated in the following situations:

Application to the eyes or mucous membranes is prohibited due to the potential for irritation or adverse reactions. The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, tight bandaging is contraindicated, as it may impede circulation or cause discomfort. The use of this product in conjunction with heating pads or external heat sources is also contraindicated, as this may increase the risk of adverse effects.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should be used only as directed by a healthcare professional. Care should be taken to avoid contact with the eyes and mucous membranes, as exposure may lead to irritation. It is contraindicated to apply the product to wounds or damaged skin, and users should refrain from tightly bandaging the area of application. Additionally, the use of heating pads or any form of external heat in conjunction with this product is not recommended, as it may exacerbate adverse effects.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: skin redness or excessive irritation, worsening of the condition, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only. It is imperative to use the product strictly as directed and to avoid contact with the eyes or mucous membranes. Application to wounds or damaged skin is contraindicated, and the product should not be bandaged tightly or used in conjunction with a heating pad or external heat.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience skin redness or excessive irritation. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Ultra Strength Muscle Rub.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 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.

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

It is important to emphasize to patients that they should use the product only as directed. They should be cautioned against getting the product into their eyes or on mucous membranes, and it should not be applied to wounds or damaged skin. Patients should also be instructed not to bandage the area tightly and to avoid using the product in conjunction with a heating pad or applying external heat.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from excessive heat sources. Freezing is not permitted, as it may compromise the product's quality.

To maintain optimal conditions, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ultra Strength 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 Ultra Strength 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.