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Ultra Strenght Muscle Rub

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This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 8 g/100 mL
  • Methyl Salicylate 30 g/100 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 2019
Label revision date
May 7, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 8 g/100 mL
  • Methyl Salicylate 30 g/100 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 2019
Label revision date
May 7, 2019
Manufacturer
Inspec Solutions LLC.
Registration number
part348
NDC root
72667-010
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

Muscle Rub is a topical product designed to provide temporary relief for minor aches and pains in your muscles and joints. It can be particularly helpful if you're experiencing discomfort from everyday activities or physical exertion. By applying Muscle Rub to the affected area, you can experience soothing relief that may help you feel more comfortable and active.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It’s designed to help you feel more comfortable when dealing with these everyday discomforts.

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 who may be concerned about such risks.

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 or older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If the patient is a child under 12 years old, it's best to consult a doctor before use. They can provide guidance on the appropriate dosage and application for younger patients. Always prioritize safety and follow the advice of a healthcare professional.

What to Avoid

It's important to use this product safely to avoid potential issues. You should stop using it if you experience excessive skin irritation. Additionally, be careful to keep it away from your eyes and mucous membranes, as contact can cause discomfort.

If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, you should also discontinue use. Redness or use in children under 12 years of age warrants immediate consultation with a physician. Always prioritize your health and safety when using any medication.

Side Effects

You should be aware that this product is for external use only. Avoid applying it to wounds, damaged skin, or using it with a heating pad, as this can lead to complications. If you experience excessive skin irritation, stop using the product right away.

Be careful to keep it away from your eyes and mucous membranes. If your condition worsens, symptoms last more than 7 days, or if they clear up and then return within a few days, you should discontinue use and consult a physician, especially if the affected person is a child under 12 years old.

Warnings and Precautions

This product is for external use only. Avoid applying it to wounds or damaged skin, and do not use it with a heating pad or bandage it tightly. It's important to keep this product out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a poison control center immediately.

You should stop using this product and call your doctor if you experience excessive skin irritation, if it gets into your eyes or mucous membranes, or if your condition worsens. If symptoms last more than 7 days, improve and then return, or if you notice redness, especially in children under 12 years old, discontinue use and consult a physician right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering 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 are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering using this product for your child, it's important to be cautious. You should stop using it if you notice excessive skin irritation, if it gets into your child's eyes or mucous membranes, or if their condition worsens. If symptoms last more than 7 days, clear up and then return, or if there is any redness, you should consult a doctor. For children under 12 years of age, it's essential to ask a doctor before use.

For adults and children aged 12 and older, apply the product to the affected area no more than 3 to 4 times a day. Always keep the product out of reach of children to prevent accidental poisoning. If your child accidentally swallows it, seek medical help or contact a poison control center immediately.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking multiple medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and overall treatment goals. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to communicate openly with your healthcare provider about any medications you are taking. In this case, there are no reported interactions with other drugs or laboratory tests. This means that, based on current information, you can feel confident that your treatment should not interfere with other medications or tests you may need.

However, always keep in mind that individual responses can vary, and new information can emerge. Therefore, discussing your full medication list and any upcoming tests with your healthcare provider is essential to ensure your safety and the effectiveness of your treatment.

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 to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you handle 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 a day. This means you can put it directly on the skin where you need relief, but be careful not to exceed the recommended frequency. If you have any questions about how to use it or its effects, consult your healthcare provider for guidance.

FAQ

What is Muscle Rub used for?

Muscle Rub is used for temporary relief of minor aches and pains of muscles and joints.

How should I use Muscle Rub?

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

Are there any contraindications for using Muscle Rub?

No specific contraindications are mentioned for Muscle Rub.

What should I do if I experience skin irritation?

Discontinue use if excessive skin irritation develops and consult a physician if the condition worsens or persists for more than 7 days.

Can I use Muscle Rub on wounds or damaged skin?

No, you should not apply Muscle Rub to wounds or damaged skin.

Is Muscle Rub safe for use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of Muscle Rub during pregnancy or lactation.

What precautions should I take when using Muscle Rub?

Keep Muscle Rub out of reach of children, avoid contact with eyes or mucous membranes, and do not bandage tightly or use with a heating pad.

How should I store Muscle Rub?

Store Muscle Rub at room temperature, protect it from excessive heat, and keep the tube tightly closed when not in use.

Packaging Info

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

Packaging configurations for Ultra Strenght Muscle Rub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Muscle Rub is a topical formulation designed for the relief of muscle discomfort. It is presented in an ointment dosage form, characterized by its semi-solid consistency. The product is intended for external use and is typically applied to the affected areas to provide localized relief. The formulation may contain a combination of active ingredients that contribute to its analgesic and anti-inflammatory properties. The appearance of Muscle Rub is generally a smooth, homogenous mixture, suitable for easy application on the skin.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be used only as directed. For adults and children aged 12 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Discontinue use if excessive skin irritation develops. Avoid contact with eyes and mucous membranes. If the condition worsens, symptoms persist for more than 7 days, or if symptoms clear and recur within a few days, or if redness is present, discontinue use and consult a physician immediately. This product is not recommended for use in children under 12 years of age.

Warnings and Precautions

For external use only. It is imperative that the product is not applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, care should be taken to avoid tight bandaging of the area where the product is applied.

To ensure safety, the product must be kept out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance should be sought, or contact with a poison control center is advised.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if excessive skin irritation occurs. The product should be kept away from the eyes and mucous membranes. If the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the patient should stop using the product and consult a physician. Special caution is warranted for use in children under 12 years of age; if any redness is observed, the product should be discontinued, and medical consultation is recommended.

Side Effects

Patients using this product should be aware of several important warnings and cautions regarding its use. The product is intended for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad, and care should be taken to avoid bandaging tightly over the application site.

In terms of adverse reactions, patients are advised to discontinue use if excessive irritation of the skin develops. It is also crucial to avoid contact with the eyes or mucous membranes, as this may lead to further complications. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should stop using the product and consult a physician immediately. This is particularly important for conditions affecting children under 12 years of age, where medical advice should be sought without delay.

Drug Interactions

No drug interactions have been reported for this medication. Additionally, there are no known interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Ultra Strenght Muscle Rub.
Details

Pediatric Use

Pediatric patients should use this medication with caution. It is advised to discontinue use if excessive skin irritation develops, if the product comes into contact with the eyes or mucous membranes, or if the condition worsens. Additionally, if symptoms persist for more than 7 days, clear up and then recur within a few days, or if redness is present, the use should be stopped, and a physician should be consulted, particularly for children under 12 years of age.

For dosing, the medication is indicated for adults and children 12 years of age and older, with application to the affected area not exceeding 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor before use.

Furthermore, this product should be kept out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance or contact with a poison control center is necessary.

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 specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning 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 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 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 excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount and timing of the overdose, is crucial for ongoing patient management and for informing any necessary 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental poisoning. In the event of ingestion, patients should seek medical assistance or contact a poison control center immediately.

Providers should caution patients to discontinue use if they experience excessive skin irritation. It is important to instruct patients to avoid contact with the eyes and mucous membranes to prevent adverse reactions.

Patients should be informed that if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use and consult a physician without delay. This is particularly crucial for patients with conditions affecting children under 12 years of age.

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. To maintain the quality of the product, 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 application to the affected area recommended no more than 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ultra Strenght 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 Strenght 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.