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Joint and Muscle Pain

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Active ingredient
Menthol 50 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 2020
Label revision date
January 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 50 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 2020
Label revision date
January 30, 2024
Manufacturer
Shaklee Corporation
Registration number
M017
NDC root
59899-022
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 for minor pain in muscles and joints. It can be particularly helpful for conditions such as backache, arthritis, bruises, and sprains. By targeting these areas, it aims to alleviate discomfort and improve your overall mobility.

Uses

If you're dealing with minor pain in your muscles and joints, this medication can help provide temporary relief. It's effective for various conditions, including backaches, arthritis, bruises, and sprains. Whether you're recovering from an injury or managing chronic pain, this treatment can assist in easing your discomfort.

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 concerned about such risks.

Dosage and Administration

To use this medication effectively, start by applying a generous amount to the area that is causing you pain. Make sure to massage it well into the skin to help it absorb properly. You can repeat this process as needed, but be careful not to apply it more than 3 to 4 times a day.

If you are an adult or a child over the age of 2, you can use this medication as directed. However, if the person needing treatment is under the age of 2, it’s important to consult a physician (doctor) before using it. This ensures safety and proper care for younger children.

What to Avoid

It's important to follow specific guidelines when using this product to ensure your safety and well-being. You should not use it with a heating pad, apply it to wounds or damaged skin, or bandage tightly after use. Additionally, avoid contact with your eyes. If your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, please discontinue use and consult a physician.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, adhering to these instructions is crucial for your health.

Side Effects

This product is intended for external use only. You should avoid using it with a heating pad, applying it to wounds or damaged skin, and bandaging tightly after use. It's important to keep it away from your eyes. If your condition worsens, persists for more than 7 days, or clears up and then returns within a few days, discontinue use and consult a physician.

Make sure to keep this product out of reach of children. If it is swallowed, seek medical help or contact a poison control center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on wounds or damaged skin, and do not apply it with a heating pad or bandage it tightly afterward. Be careful to keep it away from your eyes, as contact can cause irritation.

If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor. In case of accidental swallowing, seek medical help or contact a poison control center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Seek medical help immediately or contact a poison control center for guidance.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, do not wait—get help right away. Your safety is the top priority, so don’t hesitate to reach out for assistance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to avoid using this medication unless your doctor specifically advises you to do so. The safety of this medication during pregnancy has not been established, and the potential risks to your developing baby are unknown.

Always consult with your physician before using this medication. If it is deemed necessary, your doctor will help you weigh the benefits against any possible risks to ensure the best outcome for you and your baby.

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 known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

It's important to be cautious when considering this medication for children. If your child is over the age of 2, you should not use this medication without first consulting a physician (a medical doctor). For children under the age of 2, there are no specific instructions provided, but it is generally implied that this medication should not be used.

Always prioritize your child's safety by discussing any medications with their healthcare provider to ensure they are appropriate for your child's age and health needs.

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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious when using certain medications or treatments. For instance, you should avoid using a heating pad while taking this medication, as it can lead to unwanted effects.

While there are no specific interactions with laboratory tests, it's always a good idea to discuss all your medications and any tests you may need with your healthcare provider. They can help ensure that everything works safely and effectively together.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. 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 the medication generously to the affected area and massage it well into the painful spot. You can repeat this process as needed, but do not apply it more than 3 to 4 times a day. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available at this time.

FAQ

What is the primary use of this drug?

This drug provides penetrating temporary relief for minor pain in muscles and joints associated with backache, arthritis, bruises, and sprains.

How should I apply this drug?

Apply generously to the affected area and massage well into the painful area. You can repeat this process as necessary, but not more than 3 to 4 times daily.

Are there any contraindications for using this drug?

There are no specific contraindications listed, but you should not use it with a heating pad, on wounds or damaged skin, or bandage tightly after use.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and you should consult a physician before use, as the risk to the fetus is unknown.

What should I do if I experience worsening symptoms?

Discontinue use and consult a physician if your condition worsens or if symptoms persist for more than 7 days.

Can children use this drug?

Adults and children over the age of 2 can use it as directed, but children under the age of 2 should not use it without consulting a physician.

What precautions should I take when using this drug?

Avoid contact with eyes, and if swallowed, seek medical help or contact a poison control center immediately.

How should I store this drug?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use. Discard after opening.

Packaging Info

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

Packaging configurations for Joint and Muscle Pain.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor pain in muscles and joints associated with conditions such as backache, arthritis, bruises, and sprains.

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

Dosage and Administration

The medication should be applied generously to the affected area. It is recommended to massage the formulation well into the painful area to enhance absorption and efficacy. The application may be repeated as necessary, but should not exceed 3 to 4 times daily.

For adults and children over the age of 2, the medication should be used as directed. It is contraindicated for use in children under the age of 2; in such cases, consultation with a physician is advised prior to use.

Contraindications

The product should not be used in conjunction with a heating pad. It is contraindicated for application on wounds or damaged skin, and tight bandaging after use is not recommended. Contact with the eyes must be avoided. Discontinue use and consult a physician if the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. This product should not be used in conjunction with a heating pad, nor should it be applied to wounds or damaged skin. It is imperative to avoid tight bandaging after application to ensure safety and efficacy.

Healthcare professionals should advise patients to avoid contact with the eyes. In the event of accidental contact, immediate rinsing with water is recommended.

Patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In cases of ingestion, it is crucial to obtain medical assistance or contact a poison control center immediately. Monitoring for adverse reactions and ensuring patient safety is essential during the use of this product.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use with heating pads and should not be applied to wounds or damaged skin. Additionally, patients should avoid bandaging tightly after application and ensure that the product does not come into contact with the eyes.

In the event that 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 are advised to discontinue use and consult a physician.

It is crucial to keep this product out of the reach of children. If ingested, patients should seek medical assistance or contact a poison control center immediately.

Drug Interactions

The use of this medication is contraindicated with heating pads due to the potential for increased risk of adverse effects. It is advised that patients refrain from using heating pads while on this medication to avoid any complications.

There are no specific drug or laboratory test interactions reported for this medication. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Joint and Muscle Pain.
Details

Pediatric Use

Pediatric patients under the age of 2 should not use this medication, as specific instructions for this age group are not provided. For children over the age of 2, the medication is not recommended without consulting a physician. It is essential for healthcare professionals to evaluate the appropriateness of this treatment in pediatric populations, considering the lack of established safety and efficacy data in these age groups.

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

The use of this medication during pregnancy is not recommended. Safety during pregnancy has not been established, and the potential risks to the fetus remain unknown. Pregnant patients should only consider the use of this medication if it is clearly needed and if the benefits outweigh the risks. It is essential for healthcare providers to consult with patients regarding the potential implications and to evaluate the necessity of treatment on a case-by-case basis.

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 during the use of this product.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to 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 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a poison control center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 seek immediate medical assistance or contact a poison control center if the product is swallowed. It is important to inform patients that the product should not be used in conjunction with a heating pad, nor should it be applied to wounds or damaged skin. Patients should also be cautioned against tightly bandaging the area after application.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes. Patients should be instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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 direct light exposure. To maintain the product's quality, it is essential to keep the tube tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with a recommendation to apply generously to the affected area and to massage well into the painful area. Patients may repeat the application as necessary, but should not exceed 3 to 4 applications daily. 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 Joint and Muscle Pain, 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 Joint and Muscle Pain, 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.