Muscle

Description

Muscle Jel is a topical formulation designed for the relief of muscle and joint discomfort. It is presented in a gel dosage form, facilitating easy application to affected areas. The product is characterized by its clear appearance, which allows for discreet use. The formulation is designed to penetrate the skin effectively, providing targeted relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 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 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. It is crucial not to apply the product to wounds or damaged skin, as this may lead to adverse effects. Additionally, patients should be instructed not to bandage the area tightly after application to ensure proper ventilation and reduce the risk of irritation.

Patients must be informed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if the condition resolves and then recurs within a few days. These signs may indicate a need for further evaluation and management.

In the event of accidental ingestion, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt action is essential to ensure patient safety and appropriate care.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly after application.

In the event that conditions worsen, symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days, patients are advised to stop use and consult a doctor.

This product should be kept out of the reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not 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 safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There are no adequate and well-controlled studies in pregnant women; therefore, the potential risks to the fetus remain unknown. No specific dosage modifications are recommended for pregnant women. It is advised that this product be used only if clearly needed, and the risks and benefits should be thoroughly discussed with a healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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, 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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand that they should discontinue use and consult a healthcare provider if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be informed to stop using the product and consult a doctor if the condition resolves but recurs within a few days.

While using this product, patients must be cautioned to avoid contact with the eyes. They should also be instructed not to apply the product to wounds or damaged skin. Furthermore, patients should refrain from tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy and stability.

After application, it is important for healthcare professionals to wash their hands thoroughly and rinse with cool water to ensure proper hygiene. Additionally, the product should be discarded after opening to prevent contamination and ensure patient safety.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only, and contact with the eyes should be avoided. It should not be applied to wounds or damaged skin, and tight bandaging is discouraged. Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist beyond 7 days, or if the condition resolves and recurs within a few days. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)