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Muscle Rub

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This product has been discontinued

Active ingredient
Menthol 1.05 g/42 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2013
Label revision date
July 10, 2013
Active ingredient
Menthol 1.05 g/42 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2013
Label revision date
July 10, 2013
Manufacturer
Personal Care Products, Inc.
Registration number
part348
NDC root
29500-2433

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

Drug Overview

DRUGSTORE-Rx SMART WELLNESS Ultra Strength Muscle Rub is a pain-relieving cream designed to temporarily relieve minor aches and pains in muscles and joints. It is particularly effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This cream is known for its fast-penetrating and long-lasting effects, making it a convenient option for those seeking relief from muscle and joint discomfort.

Uses

You can use this medication to temporarily relieve 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 experiencing discomfort from arthritis, backache, muscle pain, or joint pain, this medication can help alleviate those symptoms.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those 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 keep this medication out of reach of children to prevent accidental ingestion. If a child swallows it, seek medical help or contact a Poison Control Center right away.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always use it responsibly and as directed.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens or if symptoms last longer than 7 days. Additionally, if you experience excessive skin irritation or if your symptoms improve and then return within a few days, seek medical advice.

Remember to avoid contact with your eyes and mucous membranes, and do not apply the product to wounds or damaged skin. It's also advised not to use it with a heating pad or on children under 12 years of age with arthritis-like conditions. Always use the product as directed to minimize risks.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Do not use it with a heating pad, and it is not recommended for children under 12 years old who have arthritis-like conditions. If you notice any redness in the area you plan to treat, consult your doctor before using the product. While using it, be careful to keep it away from your eyes and mucous membranes, and do not wrap the area tightly.

You should stop using the product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, if you experience excessive skin irritation, or if your symptoms improve and then return within a few days. If the product is swallowed, seek emergency 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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product has not been evaluated during pregnancy. There are no specific contraindications listed, but the safety of menthol, a key ingredient, has not been established. Therefore, it is crucial to consult your healthcare provider before using this product.

While there are no specific dosage modifications recommended for pregnant individuals, seeking medical advice is strongly advised to ensure your safety and the well-being of your baby. Always prioritize open communication with your healthcare team regarding any products you consider using during this time.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental swallowing. If a child does swallow it, seek medical help or contact a Poison Control Center right away. For children under 12 years old, especially those with arthritis-like conditions, you should not use this medication without consulting a doctor first.

For children aged 12 and older, you can apply the medication to the affected area, but be sure to limit use to no more than 3 to 4 times a day. Always prioritize safety and consult a healthcare professional if you have any questions or concerns about using this medication for your child.

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 wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always ensure that your healthcare team is aware of all medications being taken, as older adults may have different responses to treatments. Regular check-ins with your doctor can help monitor for any side effects or necessary adjustments in dosage.

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 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, so don't hesitate to ask questions or express any concerns you may have.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at temperatures between 59° and 86° F (15° and 30° C). After each use, make sure to close the cap tightly to prevent contamination and maintain the product's integrity.

It's important to check the seal on the tube before use; do not use the product if the seal is punctured or missing, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is DRUGSTORE-Rx SMART WELLNESS Ultra Strength Muscle Rub used for?

It is a pain-relieving cream that temporarily relieves minor aches and pains of muscles and joints, including conditions like backache, arthritis, strains, bruises, and sprains.

How should I use this muscle rub?

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

Are there any warnings I should be aware of?

Yes, it is for external use only. Do not use on wounds or damaged skin, with a heating pad, or on children under 12 with arthritis-like conditions.

What should I do if I accidentally swallow the product?

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

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established. Consult a healthcare provider before use if you are pregnant or planning to become pregnant.

Can nursing mothers use this product?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

What should I do if my condition worsens or symptoms persist?

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

How should I store this muscle rub?

Store between 59° and 86° F (15° and 30° C) and close the cap tightly after use. Do not use if the seal on the tube is punctured or missing.

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

SMART WELLNESS Ultra Strength Muscle Rub is a pain-relieving cream analgesic formulated for topical application. Each container has a net weight of 1.5 ounces (42 grams) and is distributed by PERSONAL CARE PRODUCTS, LLC, located in Troy, Michigan, U.S.A. The product is manufactured in India and is identified by code number MH/DRUGS/KD-313.

This formulation is characterized by its fast-penetrating and long-lasting properties. It is indicated for the relief of minor arthritis, backache, muscle pain, and joint pain.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including but not limited to simple backache, arthritis, strains, bruises, and sprains. It provides symptomatic relief for conditions such as arthritis, backache, muscle pain, and joint pain.

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 children due to the risk of accidental ingestion. It is essential to keep the product out of reach of children. In the event of accidental swallowing, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin, and it should not be used in conjunction with a heating pad. Additionally, it is not recommended for use on children under 12 years of age who present with arthritis-like conditions. Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Furthermore, patients should be instructed not to apply tight bandages over the treated area.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days, excessive skin irritation develops, or if symptoms resolve only to recur within a few days.

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

Side Effects

Patients using this product should be aware that it 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 or on children under 12 years of age with arthritis-like conditions.

During the use of this product, it is important to avoid contact with the eyes or mucous membranes, and patients should refrain from tightly bandaging the area of application.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, if excessive skin irritation occurs, or if symptoms resolve and then recur within a few days.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 should be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

For children under 12 years of age, it is recommended to consult a healthcare professional before use, particularly for those with arthritis-like conditions, as the product is not indicated for this age group in such cases.

For adolescents aged 12 years and older, the product may be applied to the affected area no more than 3 to 4 times daily.

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

The product has not been evaluated for safety during pregnancy. Therefore, the safety of menthol during pregnancy has not been established. Pregnant patients or those planning to become pregnant are advised to consult a healthcare provider before using this product. There are no specific contraindications listed for use during pregnancy, and no specific dosage modifications for pregnant individuals are provided. Caution is recommended, and medical advice should be sought prior to use.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in managing potential overdosage cases.

Continued vigilance and adherence to recommended dosing guidelines are crucial to minimize the risk of overdosage and ensure patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 ingestion. It is important to emphasize the potential risks associated with ingestion by children. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

Storage and Handling

The product is supplied in a configuration that includes a tube with a secure seal. It is essential to store the product at a temperature range of 59° to 86° F (15° to 30° C) to maintain its efficacy. After each use, the cap should be closed tightly to prevent contamination and preserve the integrity of the product. Users are advised not to use the product if the seal on the tube is punctured or missing, as this may compromise safety and effectiveness.

Additional Clinical Information

No further data are available.

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.

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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.