Muscle and Joint

Description

This product is a topical formulation designed for the relief of muscle and joint pain. It is intended for application to affected areas to provide localized analgesic effects. The formulation is characterized by its specific composition, which facilitates the penetration of active ingredients through the skin to target pain at the source. The product is presented in a convenient rub form, allowing for easy application and absorption.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 12 years of age, it is advised to consult a physician before use. This ensures appropriate guidance and safety measures are taken for this age group.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. It should not be used in conjunction with a heating pad, as this may increase the risk of burns or skin damage. Additionally, the product is contraindicated for children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

While using this product, it is essential to avoid contact with eyes or mucous membranes to prevent irritation. Furthermore, do not apply tight bandages, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to consult a doctor prior to use if there is any redness present over the affected area. During application, it is crucial to avoid contact with the eyes or mucous membranes, and patients should be instructed not to apply a tight bandage over the treated area.

Patients must be informed to discontinue use and seek medical advice if the condition worsens or if symptoms persist beyond 7 days. Additionally, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical consultation is necessary.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made.

Side Effects

Patients should discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

Before using the product, patients are advised to consult a healthcare provider if there is redness over the affected area.

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 and Joint (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with arthritis-like conditions should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients may use this product as there is no specific information regarding its use during pregnancy provided in the drug insert. Additionally, there are no contraindications noted for use in pregnant individuals, nor are there any associated risks to the fetus identified in the available data. Furthermore, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the benefits against any potential risks.

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 not been specifically addressed in the drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

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

Overdosage

In the event of an overdosage, it is imperative that immediate medical assistance is sought. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; however, prompt recognition and intervention are crucial. The management of overdosage typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

Healthcare providers are encouraged to monitor the patient closely for any adverse effects and to initiate appropriate therapeutic measures as necessary.

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 use of the compound in these contexts.

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 instruct patients not to apply the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed that the product is not recommended for use in children under 12 years of age who have arthritis-like conditions. They should be counseled to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using the product, patients must be cautioned to avoid contact with the eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Furthermore, patients should be encouraged to consult a doctor before using the product if there is any redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20°C to 25°C (68°F to 77°F) to maintain its integrity and efficacy. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any potential degradation of the product during storage and transportation.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 12 years and older being 3 to 4 times daily to the affected area. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)