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Theracare Muscle and Joint Gel

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Active ingredient
Menthol 2.5 g/100 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 2026
Label revision date
January 26, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 2.5 g/100 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 2026
Label revision date
January 26, 2026
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-129
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

You can use this medication for temporary relief from minor aches and pains associated with sore muscles and joints. It is particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means that if you're experiencing discomfort from these issues, this drug may provide you with some much-needed relief.

Uses

You can use this medication for temporary relief from minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, as this can lead to complications. Additionally, be careful to avoid contact with your eyes while using the product, as this can cause irritation. Lastly, when applying, do not bandage the area tightly, as this may affect how the product works.

By following these guidelines, you can help ensure a safe and effective experience with the product. If you have any questions or concerns, don't hesitate to reach out for more information.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should only use it externally and avoid applying it to wounds or damaged skin. Be careful to keep it away from your eyes and do not wrap the area tightly with a bandage. If your condition worsens, or if symptoms last more than seven days or return shortly after improvement, stop using the product and consult a doctor.

If you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before using this product. Additionally, keep it out of reach of children, and in the event of accidental ingestion, seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. While using it, be careful not to let it come into contact with your eyes, and do not wrap the area tightly with a bandage.

If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, stop using the product and consult your doctor. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if a child accidentally ingests it, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally ingests it, you should seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Signs of an overdose can vary, but if you suspect that someone has taken too much, it's crucial to act quickly. Always prioritize safety and don't hesitate to reach out for professional assistance.

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

If you have a child aged 2 years or older, you can apply this medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important not to use this medication without consulting a doctor first. Always prioritize your child's safety and seek professional advice when needed.

Geriatric Use

While there is no specific information about the use of TheraCare Muscle & Joint Gel in older adults, it's always important to approach any new treatment with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before starting this product. They can help ensure that it is appropriate for your needs and discuss any potential interactions with other medications you may be taking. Always prioritize your health and safety by seeking personalized advice.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. Before using, check that the tube seal under the cap is intact; do not use the product if the seal is broken, as this could compromise its safety and effectiveness. Always handle the product with care to avoid any damage.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug provides temporary relief from minor aches and pains of sore muscles and joints associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

Who can use this drug?

Adults and children 2 years of age and older can apply it to the affected area 3 to 4 times daily. Children under 2 years of age should not use it without consulting a doctor.

Are there any contraindications for this drug?

There are no specified contraindications, but you should not use it on wounds or damaged skin.

What precautions should I take when using this drug?

Avoid contact with eyes and do not bandage tightly when using this product.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days or return after clearing up.

Is it safe to use this drug during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this drug.

How should I store this drug?

Store at room temperature and do not use if the tube seal under the cap is broken.

What should I do in case of accidental ingestion?

Keep this drug out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

Packaging Info

Below are the non-prescription pack sizes of Theracare Muscle and Joint Gel (menthol 2.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theracare Muscle and Joint Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

Adults and children aged 2 years and older should apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended; healthcare professionals should be consulted for guidance.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation or adverse effects. Additionally, it should not be applied in a manner that allows contact with the eyes, as this may lead to discomfort or injury. Tight bandaging is also contraindicated, as it may restrict circulation and cause further complications.

Warnings and Precautions

This product is intended for external use only and should not be applied to wounds or damaged skin. Healthcare professionals should advise patients to avoid contact with the eyes during application. Additionally, it is important to instruct patients not to bandage the area tightly after application to prevent complications.

Patients should be closely monitored for any worsening of their condition or if symptoms persist beyond 7 days. If symptoms improve and then recur within a few days, it is recommended that patients discontinue use and consult a healthcare provider for further evaluation.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional prior to using this product to ensure safety for both the mother and child.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. During use, it is important to avoid contact with the eyes and to refrain from tightly bandaging the area.

Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional prior to use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or the Poison Control Center (800-222-1222) should be contacted.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Theracare Muscle and Joint Gel (menthol 2.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theracare Muscle and Joint Gel.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of TheraCare Muscle & Joint Gel, as the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions for this population. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the absence of data that may inform the safety and efficacy of the gel in this age group. Monitoring for any adverse effects or unexpected responses is advisable when administering this treatment to elderly individuals.

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 currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of overdosage, it is crucial to keep the product out of reach of children to prevent accidental ingestion. Should accidental ingestion occur, immediate medical assistance is necessary. Healthcare professionals are advised to contact a Poison Control Center at 800-222-1222 for guidance on appropriate management and treatment protocols.

Prompt action is essential in managing overdosage cases to mitigate potential health risks. It is recommended that healthcare providers assess the situation thoroughly and follow established protocols for the evaluation and treatment of overdosage.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

While using this product, patients should be cautioned to avoid contact with their eyes and to refrain from bandaging the area tightly.

Storage and Handling

The product is supplied in a configuration that includes a tube with a secure cap. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Healthcare professionals should ensure that the tube seal under the cap is intact before use; the product should not be utilized if this seal is broken, as it may compromise the quality and safety of the contents.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Theracare Muscle and Joint Gel, 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 Theracare Muscle and Joint Gel, 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.