Muscle and Joint

Description

This product is a topical formulation designed for the relief of muscle and joint pain. It is applied directly to the affected areas to provide localized analgesic effects. The formulation is intended for external use only and is characterized by its specific consistency and texture suitable for easy application.

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. The application should be performed with clean hands, ensuring that the affected area is dry before application.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

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 in 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 compromise 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 on 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 warranted.

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 using this product should be aware of several important safety considerations. This product 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 who have arthritis-like conditions.

Before using this product, patients are advised to consult a healthcare professional if there is redness over the affected area. While using the product, it is crucial to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; or if excessive skin irritation develops.

It is also important 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.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions between this drug and laboratory tests. Therefore, no specific 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 with arthritis-like conditions should not be treated with this medication if they are under 12 years of age. For children under 12, it is advised to consult a healthcare professional before use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when using this product while breastfeeding. The effects on a nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 and mucous membranes. They should also be instructed not to apply a tight bandage over the treated area. Furthermore, patients should be encouraged to consult a doctor before using the product if there is any redness present 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° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 12 years and older being no more than 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 additional 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)