Menthol

Description

Muscle Rub is a topical formulation designed for the relief of muscle discomfort. It is presented in an ointment dosage form, characterized by its semi-solid consistency. The product is intended for external use and is typically applied to the affected areas to provide localized relief. The formulation may contain a combination of active ingredients that contribute to its analgesic and anti-inflammatory properties. The appearance of Muscle Rub is generally a smooth, homogenous mixture, suitable for easy application on the skin.

Uses and Indications

Muscle Rub is indicated for the relief of muscle pain.

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

Dosage and Administration

For adults and children aged 12 years and older, a thin layer of the medication should be applied to the affected area three to four times daily. It is important to ensure that the application is consistent and covers the entire affected area for optimal results.

For children under 12 years of age, it is recommended to consult a physician prior to use to determine the appropriate course of action.

After application, healthcare professionals should advise patients to wash their hands thoroughly to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse effects. The use of a heating pad in conjunction with this product is also contraindicated, as it may lead to excessive heat and increase the risk of burns or skin damage.

This product should not be administered to children under 12 years of age, as safety and efficacy have not been established in this population. Additionally, use is contraindicated in pregnant or breastfeeding individuals due to potential risks to the fetus or infant.

Warnings and Precautions

For external use only, this product must be applied with caution to prevent contact with the eyes and mucous membranes. It is imperative to avoid tight bandaging of the area where the product is applied.

General precautions should be observed to ensure safe use. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, it is contraindicated for use in children under 12 years of age, as well as in individuals who are pregnant or breastfeeding.

Healthcare professionals should advise patients to discontinue use and consult a physician 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. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients using this product should be aware of specific warnings and potential adverse reactions associated with its use. The product is intended for external use only, and it is crucial to avoid contact with the eyes and mucous membranes. Additionally, patients should not bandage the area tightly.

In the event that the condition worsens or symptoms persist for more than 7 days, patients are advised to stop using the product and consult a physician. If symptoms initially clear up but then recur within a few days, it is also recommended to seek medical advice. Furthermore, excessive skin irritation is a reason to discontinue use and consult a healthcare professional.

These precautions are essential to ensure the safety and well-being of patients while using this product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For children in this age group, consultation with a physician is advised prior to use.

For adolescents aged 12 years and older, the recommended dosage is to apply a thin layer to the affected area 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information available 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

Pregnant patients and those who are breastfeeding should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in lactating women is also unclear. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or breastfeeding to avoid any potential adverse effects on fetal outcomes or infant health.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. There is insufficient data regarding the excretion of the drug in human breast milk and its effects on breastfed infants. Therefore, the potential risks to the nursing infant outweigh any possible benefits of treatment in lactating mothers.

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals due to potential teratogenic effects. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to apply the product on wounds or damaged skin, as this may lead to adverse effects. It is also important to inform patients that the product should not be used in conjunction with a heating pad, as this could increase the risk of skin irritation or other complications.

Patients should be cautioned against using the product on children under 12 years of age, as safety and efficacy in this population have not been established. Additionally, pregnant or breastfeeding individuals should be advised to avoid using the product, given the potential risks that have not been fully evaluated.

Healthcare providers should instruct patients to discontinue use and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. Patients should also be informed to stop using the product if symptoms initially improve but then recur within a few days. Furthermore, they should be made aware that excessive skin irritation is a reason to stop use and consult a physician.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at a temperature range of 68 to 86 degrees Fahrenheit. It is essential to keep the container tightly closed to maintain product integrity. Special handling requirements include ensuring that the lid remains securely fastened at all times to prevent contamination and degradation of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin layer to the affected area for adults and children aged 12 years and older, 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)