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Dr Sheffield Muscle Rub Cream

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Active ingredients
  • Menthol 100 mg/1 g
  • Methyl Salicylate 150 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 2002
Label revision date
November 28, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 100 mg/1 g
  • Methyl Salicylate 150 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 2002
Label revision date
November 28, 2023
Manufacturer
Sheffield Pharmaceuticals LLC
Registration number
M017
NDC root
11527-057
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 Cream is a topical analgesic, which means it is applied directly to the skin to help relieve pain. This cream contains two active ingredients: menthol (10%) and methyl salicylate (15%). It is designed to provide temporary relief from minor aches and pains in muscles and joints, including discomfort related to simple backaches, arthritis, strains, bruises, and sprains.

When you apply MUSCLE RUB Cream, the menthol and methyl salicylate work together to create a cooling sensation that can help soothe your discomfort. This makes it a convenient option for managing everyday muscle and joint pain.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backaches, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from any of these issues, this medication may help alleviate your pain and improve your mobility.

Dosage and Administration

When using this medication, you should apply it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years or older. If your child is under 2 years old, it's important to consult a doctor before use to ensure safety and proper guidance.

After applying the medication, make sure to wash your hands thoroughly with soap and water, unless you are treating your hands. This helps prevent the medication from spreading to other areas where it may not be needed. Always follow these instructions carefully to ensure the best results.

What to Avoid

It's important to keep this medication, as well as all other drugs, out of the reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always use medications responsibly and follow any additional guidance provided by your healthcare professional.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes or on mucous membranes, and do not apply it to wounds or damaged skin. If your condition worsens, symptoms persist for more than seven days, or if they clear up and return shortly after, stop using the product and consult a doctor. You may experience a temporary burning sensation upon application, but this usually goes away within a few days. If you notice excessive irritation, discontinue use immediately.

If you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product. Additionally, avoid using it with a heating pad or applying a tight bandage over the area.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes and any mucous membranes. If you notice that your condition worsens, or if symptoms last longer than 7 days or return shortly after improvement, stop using the product and consult your doctor. It's important not to apply it to wounds or damaged skin, and avoid using tight bandages or heating pads on the treated area.

You may experience a temporary burning sensation when applying the product, but this usually goes away within a few days. If you develop excessive skin irritation, discontinue use immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Lastly, if the product is swallowed, seek medical help or contact a Poison Control Center right away.

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 feel unwell after taking the medication, 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 after taking medication.

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

It's important to keep this medication and all other drugs out of the reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

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. Always prioritize safety and follow these guidelines to ensure your child's well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney issues, 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 problems).

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 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 great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, tailored specifically to your health needs.

Always keep your healthcare provider informed about any changes in your medication or health status. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° to 77°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 your product safely is crucial. Always ensure that you are in a clean environment to avoid introducing any unwanted substances. Following these simple storage and handling guidelines will help you use the product effectively and safely.

Additional Information

You can use this medication topically, applying it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is MUSCLE RUB Cream used for?

MUSCLE RUB Cream is a topical analgesic used for temporary relief of minor aches and pains of muscles and joints associated with simple backaches, arthritis, strains, bruises, and sprains.

How should I apply MUSCLE RUB Cream?

Apply MUSCLE RUB Cream to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. For children under 2 years, consult a doctor.

Are there any warnings I should be aware of?

Yes, this cream 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 accidentally swallow MUSCLE RUB Cream?

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

Can I use MUSCLE RUB Cream if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using MUSCLE RUB Cream.

What should I do if my symptoms persist?

If conditions worsen or if symptoms persist for more than 7 days, discontinue use and consult a doctor.

How should I store MUSCLE RUB Cream?

Store MUSCLE RUB Cream at controlled room temperature between 20°- 25°C (68° to 77°F) and close the cap tightly after use.

Packaging Info

Below are the non-prescription pack sizes of Dr Sheffield Muscle Rub Cream (muscle rub cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr Sheffield Muscle Rub Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Sheffield Pharmaceuticals NDC 11527-057-40 MUSCLE RUB Cream is a topical analgesic formulation containing 10% menthol and 15% methyl salicylate. The product is designed for external use and is presented in a net weight of 1.25 oz (35 g).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscle and joint conditions, including simple backaches, 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. For children under 2 years of age, it is advised to consult a doctor prior to use.

Healthcare professionals should instruct patients to wash their hands thoroughly with soap and water immediately after application, unless the treatment area involves the hands themselves. This practice helps to prevent unintended exposure to other areas of the body or to other individuals.

Contraindications

Use of this product is contraindicated in situations where it may be accessible to children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or injury. In the event that conditions worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted.

This product should not be applied to wounds or damaged skin. Additionally, it is advised not to apply a bandage tightly over the treated area, nor should it be used in conjunction with a heating pad. Application on wounds, damaged, broken (open), or irritated skin is contraindicated. Should excessive irritation of the skin develop, the use of the product must be discontinued immediately.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to use. A temporary burning sensation may occur upon application; however, this sensation typically subsides within a few days. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with eyes and mucous membranes. In clinical use, a temporary burning sensation may occur upon application; however, this sensation typically resolves within a few days.

Serious adverse reactions may arise if the product is applied to wounds, damaged, broken (open), or irritated skin. Patients are advised to discontinue use if excessive irritation of the skin develops. Additionally, if conditions worsen or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional.

It is important to note that the product should not be applied tightly with a bandage, nor should it be used in conjunction with a heating pad. Special caution is advised for pregnant or breastfeeding individuals, who should consult a health professional before use.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dr Sheffield Muscle Rub Cream (muscle rub cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dr Sheffield Muscle Rub Cream.
Details

Pediatric Use

Pediatric patients should be advised to keep this and all medications out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is essential.

For children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. However, for children under 2 years of age, consultation with a healthcare provider is recommended prior to use.

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 safe use during pregnancy and lactation.

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 mothers.

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.

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 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 initiate supportive care, 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 further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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 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 this medication and all other drugs out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to maintain its efficacy and stability.

After each use, it is crucial to close the cap tightly to prevent contamination and ensure the integrity of the product. Proper adherence to these storage and handling guidelines is necessary for optimal product performance.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to 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 Dr Sheffield Muscle Rub Cream, 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 Dr Sheffield Muscle Rub Cream, 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.