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Muscle Rub

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This product has been discontinued

Active ingredient
Menthol 0.025 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
December 13, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 0.025 g/1 g
Other brand names
Dosage form
Gel
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 2015
Label revision date
December 13, 2020
Manufacturer
Anicare Pharmaceuticals Pvt. Ltd
Registration number
part348
NDC root
47046-160
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 Gel is a topical product designed to provide soothing relief for minor arthritis pain, as well as discomfort in aching muscles, joints, and backaches. This gel can be applied directly to the affected areas to help alleviate pain and improve comfort.

With a net weight of 1.25 oz (35 g), it is a convenient option for those seeking relief from everyday aches and pains. Whether you're dealing with the strains of daily activities or specific conditions like arthritis, Muscle Rub Gel aims to support your comfort and mobility.

Uses

If you're dealing with minor arthritis pain, aching muscles, or backaches, this medication can provide soothing relief. It's designed to help ease discomfort in your joints and muscles, allowing you to feel more comfortable in your daily activities.

You can trust that this medication does not have any teratogenic effects, meaning it won't cause harm to a developing fetus if taken during pregnancy. This makes it a safer option for those who may be expecting.

Dosage and Administration

When using this medication, if you are an adult or a child aged 12 years and older, you should apply it to the affected area no more than 3 to 4 times a day. After applying, gently massage the gel into your skin until it disappears. This helps ensure that the medication is absorbed effectively.

If you have a child under 12 years of age, it’s important not to use this medication without first consulting a doctor. Always follow these guidelines to ensure safe and effective use of the product.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

You should be aware that this product is for external use only and must be used as directed. Keep it out of reach of children to prevent accidental poisoning. Avoid contact with your eyes or any mucous membranes, and if you experience excessive skin irritation, stop using the product immediately.

It's important not to apply it to wounds, broken skin, or irritated areas, and avoid using it with a heating pad. If your condition worsens, symptoms last longer than 10 days, or if you notice skin redness or irritation, discontinue use and consult a doctor. Additionally, this product is not recommended for children under 12 with arthritis-like conditions without a doctor's advice.

Warnings and Precautions

This product is for external use only, so be sure to follow the directions carefully and keep it out of reach of children to prevent accidental poisoning. Avoid getting it in your eyes or on mucous membranes, and do not apply it to wounds, broken skin, or irritated areas. It's important not to use tight bandages or heating pads with this product.

If you experience excessive skin irritation, stop using the product immediately. You should also discontinue use and consult your doctor if your condition worsens, if symptoms last longer than 10 days, or if you notice skin redness or irritation. For children under 12 with arthritis-like conditions, please consult a doctor before use. 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 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. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using Muscle Rub (menthol gel) during pregnancy, there is currently no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that the effects of this product on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby when considering any medication or topical treatment.

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 particular considerations or precautions noted about lactation or the possibility of the product being passed into breast milk. This means that, based on the available information, you can use this product without special concerns for your breastfeeding routine.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. This is especially crucial for children with arthritis-like conditions, as the medication is not recommended for them. Always prioritize your child's health by seeking professional advice to ensure safe and appropriate treatment options.

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 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 plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 15°C to 30°C (59°F to 86°F). This temperature range helps maintain the product's effectiveness and safety. Always check the lot number and expiration date, which can be found on the crimp of the tube, to ensure you are using a valid and safe product.

When handling the product, make sure to do so in a clean environment to avoid contamination. 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 a day. Gently massage the gel into your skin until it disappears. If you are treating a child under 12 years old, do not use this product without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Muscle Rub Gel used for?

Muscle Rub Gel provides soothing relief of minor arthritis pain, aching muscles, joints, and backaches.

How should I use Muscle Rub Gel?

For adults and children 12 years and older, apply to the affected area not more than 3 to 4 times daily and gently massage until the gel disappears. Do not use in children under 12 years of age without consulting a doctor.

Are there any warnings for using Muscle Rub Gel?

Yes, it is for external use only. Avoid contact with eyes or mucous membranes, and discontinue use if excessive skin irritation occurs.

What should I do if I swallow Muscle Rub Gel?

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

Is Muscle Rub Gel safe to use during pregnancy?

There is no specific information regarding the use of Muscle Rub Gel during pregnancy, so consult your doctor before use.

Can nursing mothers use Muscle Rub Gel?

There are no specific warnings or recommendations regarding the use of Muscle Rub Gel by nursing mothers.

What should I do if my condition worsens while using Muscle Rub Gel?

If your condition worsens, or if symptoms persist for more than 10 days, discontinue use and consult a doctor.

How should I store Muscle Rub Gel?

Store Muscle Rub Gel at a controlled room temperature of 15°C to 30°C (59°F to 86°F).

Packaging Info

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

Packaging configurations for Muscle Rub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

MUSCLE RUB GEL is a topical formulation designed for application to the skin. The product is packaged in a net weight of 1.25 ounces (35 grams).

Uses and Indications

This drug is indicated for the soothing relief of minor arthritis pain, as well as for alleviating aching muscles, joints, and backaches.

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 dosage is to apply the gel to the affected area no more than 3 to 4 times daily. The application should be followed by gentle massage until the gel is fully absorbed and disappears from the skin.

In children under 12 years of age, the use of this product is not recommended. Consultation with a healthcare professional is advised before use in this age group.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to keep the product out of reach of children to prevent accidental poisoning.

Healthcare professionals should advise patients to avoid contact with the eyes or mucous membranes, as this may lead to irritation. In the event of excessive skin irritation, the use of the product should be discontinued immediately.

Patients should be cautioned against tightly bandaging the area of application, applying the product to wounds, broken or irritated skin, or using it in conjunction with a heating pad, as these practices may exacerbate adverse effects.

Should the condition worsen, or if symptoms persist beyond 10 days, or if there is a recurrence of symptoms after initial improvement within a few days, patients are advised to discontinue use and consult a physician. Additionally, the product is not recommended for use in children under 12 years of age for arthritis-like conditions; a consultation with a healthcare provider is necessary in such cases.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product may experience adverse reactions, which can be categorized based on seriousness and frequency.

Serious adverse reactions include excessive skin irritation, which necessitates discontinuation of use. Patients are advised to avoid contact with eyes or mucous membranes, as this may lead to significant discomfort. In cases where the condition worsens, symptoms persist beyond 10 days, or if skin redness or irritation develops, it is recommended that patients discontinue use and consult a healthcare professional.

Common adverse reactions may arise from improper application, such as bandaging tightly, applying to wounds, broken or irritated skin, or using in conjunction with a heating pad. These practices can exacerbate irritation and should be avoided.

Additionally, for children under 12 with arthritis-like conditions, the use of this product is contraindicated unless directed by a doctor. It is crucial to keep the product out of reach of children to prevent accidental poisoning. Patients should adhere strictly to the directions for use to minimize the risk of adverse reactions.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Muscle Rub.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. This caution applies specifically to children with arthritis-like conditions. It is essential for healthcare providers to evaluate the appropriateness of treatment in this age group before prescribing.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Muscle Rub (menthol gel) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. It is advisable to weigh the benefits against any unknown risks when recommending this product to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by nursing mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation or the potential for excretion in breast milk.

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 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 toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt intervention in case of an emergency.

Storage and Handling

The product is supplied in a configuration that includes a unique Lot Number and Expiration Date, which can be found on the crimp of the tube.

It is essential to store the product at a controlled room temperature, maintaining a range of 15°C to 30°C (59°F to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, it should be applied to the affected area no more than 3 to 4 times daily, with gentle massage until the gel is fully absorbed. It is advised that children under 12 years of age should not use this product without consulting a doctor.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Muscle Rub, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.