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Muscle Rub Cream

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Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
January 2, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 15 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
January 2, 2024
Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Registration number
M017
NDC root
69396-110
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from these issues, this drug may offer you some relief.

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 backache, arthritis, strains, bruises, and sprains. If you're dealing with any of these discomforts, this medication may help ease your symptoms and improve your comfort.

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 12 years or older. If the patient is under 12 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 right away, unless you are treating your hands. This helps prevent the medication from spreading to other areas where it may not be needed.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your condition worsens or does not improve within 7 days. Additionally, if your symptoms clear up but then return within a few days, or if you experience excessive skin irritation, it's crucial to seek medical advice.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and safety by following these instructions closely.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to wounds, broken skin, or irritated areas, and do not use it with a heating pad. If you are pregnant or breastfeeding, consult your doctor before use. Be careful to keep the product away from your eyes and mucous membranes, and avoid wrapping the area tightly.

If your condition worsens or does not improve within a week, or if symptoms clear up and then return shortly after, you should stop using the product and consult a doctor. Some users may experience a temporary burning sensation upon application, but this usually goes away within a few days. If you notice excessive skin irritation, seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid using it on wounds, broken skin, or irritated areas. It's important not to use it with a heating pad. If you are pregnant or breastfeeding, consult your doctor before using this product. While using it, be careful to keep it away from your eyes and mucous membranes, and do not wrap the area tightly with a bandage.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center right away. You should also stop using the product and call your doctor if your condition worsens or does not improve within 7 days, if symptoms clear up and then return within a few days, or if you experience excessive skin irritation.

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 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 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 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 ensures that you understand any potential risks and can make informed decisions about your health and your baby's well-being. Always prioritize open communication with your healthcare provider to ensure safe breastfeeding practices.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can apply it to the affected area up to 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use 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 for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20º-25ºC (68º-77ºF). This temperature range helps maintain the integrity of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You can use this product on adults and children aged 12 and older by applying it to the affected area up to 3 to 4 times a day. If the user is under 12 years old, it's important to consult a doctor first. If you are pregnant or breastfeeding, ask your doctor before using this product.

While using it, avoid contact with your eyes or mucous membranes, and do not wrap the area tightly. If your condition worsens or does not improve within 7 days, if symptoms clear up and then return within a few days, or if you experience excessive skin irritation, stop using the product and consult a doctor. You may feel a temporary burning sensation upon application, but this usually goes away within a few days.

FAQ

What is the drug used for?

The drug is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I apply the drug?

Adults and children 12 years of age or older should apply it to the affected area not more than 3 to 4 times daily. Children under 12 years of age should consult a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it on wounds or damaged skin, with a heating pad, or bandage tightly.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or does not improve within 7 days, if symptoms clear up and occur again within a few days, or if excessive skin irritation develops.

Can I use this drug if I am pregnant or breastfeeding?

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

What should I do if I accidentally swallow the drug?

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

What should I avoid while using this product?

Avoid contact with eyes or mucous membranes while using this product.

What is the storage condition for this drug?

Store the drug at controlled room temperature between 20º-25ºC (68º-77ºF).

Packaging Info

Below are the non-prescription pack sizes of Muscle Rub Cream (menthol 10%, methyl salicylate 15%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle Rub Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified as "globe-muscle-rub-cream-3oz-CDER 6." It is formulated as a cream and is packaged in a 3-ounce container. The specific characteristics and composition details of the product are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

Adults and children 12 years of age or older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor prior to use.

Healthcare professionals should advise 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 transfer of the medication to other areas of the body or to other individuals.

Contraindications

There are no contraindications listed for this product.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of conditions or lack of improvement within 7 days, recurrence of symptoms after initial resolution within a few days, or development of excessive skin irritation.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or any damaged, broken (open), or irritated skin. It should not be used in conjunction with a heating pad. Healthcare professionals should advise patients to consult a physician prior to use if they are pregnant or breastfeeding.

During the application of this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, patients should be instructed not to apply tight bandages over the treated area.

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

Patients are advised to discontinue use and consult their healthcare provider if any of the following occur: the condition worsens or does not improve within 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops. Regular monitoring of the patient's response to treatment is recommended to ensure safety and efficacy.

Side Effects

Patients using this product should be aware that it is for external use only and should not be applied to wounds, damaged, broken, or irritated skin. Additionally, it should not be used in conjunction with a heating pad. Pregnant or breastfeeding patients are advised to consult a doctor prior to use.

During the application of this product, patients should avoid contact with the eyes and mucous membranes, and it is recommended not to bandage the area tightly.

Patients are instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens or does not improve within 7 days, symptoms clear up and then recur within a few days, or if excessive skin irritation develops. A temporary burning sensation may occur upon application; however, this sensation typically resolves within a few days.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Muscle Rub Cream (menthol 10%, methyl salicylate 15%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Muscle Rub Cream.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure safe use 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 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 substance taken, is crucial for effective management and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that if their condition worsens or does not improve within 7 days, they should consult their healthcare provider for further evaluation.

Patients should also be made aware that if their symptoms clear up and then reoccur within a few days, they should report this to their healthcare provider. Additionally, healthcare providers should instruct patients to monitor for any excessive skin irritation that may develop during the use of the product.

Lastly, patients should be informed that a temporary burning sensation may occur upon application; however, this sensation typically subsides within a few days. It is essential for patients to understand these potential effects to ensure proper use and to seek assistance when necessary.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20º-25ºC (68º-77ºF) to ensure optimal stability and efficacy. Care should be taken to maintain these temperature conditions throughout the storage period.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek medical advice before using the product if they are pregnant or breastfeeding. Patients should avoid contact with eyes and mucous membranes during application and should not apply tight bandages. They are instructed to discontinue use and consult a doctor if their condition worsens or does not improve within 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs. A temporary burning sensation may be experienced upon application, typically subsiding within a few days.

Drug Information (PDF)

This file contains official product information for 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 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

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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.