Muscle Rub

Description

This greaseless muscle rub cream is designed for fast penetration to provide relief from muscle aches and arthritis pain. It contains active ingredients comparable to those found in BENGAY. The product is packaged in a net weight of 1.25 oz (35 g). It is distributed by Dolgencorp, LLC, located at 100 Mission Ridge, Goodlettsville, TN 37072, and is manufactured in India. This product is not produced or distributed by Johnson and Johnson Consumer Products Company, a division of Johnson and Johnson Consumer Companies, Inc., the distributor of BENGAY.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints. It provides fast-penetrating relief specifically for muscle aches and arthritis pain.

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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals must advise patients to avoid contact with the eyes or mucous membranes, as this may lead to irritation or adverse effects.

In the event of excessive skin irritation, it is imperative to discontinue use immediately. Additionally, patients should be cautioned against tightly bandaging the area of application, applying the product to wounds or damaged skin, or using it in conjunction with a heating pad, as these practices may exacerbate irritation or lead to complications.

Should the condition worsen, or if symptoms persist beyond 7 days or recur shortly after resolution, patients are advised to discontinue use and seek medical consultation. In cases of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only and must be used strictly as directed. Contact with eyes or mucous membranes should be avoided to prevent irritation. In clinical practice, excessive skin irritation has been reported; therefore, patients are advised to discontinue use if such irritation develops.

It is important not to bandage the area tightly, apply the product to wounds or damaged skin, or use it in conjunction with a heating pad, as these actions may exacerbate adverse reactions. Should the condition worsen, or if symptoms persist for more than 7 days or recur shortly after resolution, patients should discontinue use and consult a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. These precautions are essential to ensure the safe use of the product and to minimize the risk of adverse reactions.

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 Rub (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children to prevent accidental poisoning. For adults and children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily. In children under 2 years of age, it is advised to consult a doctor before use.

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

There is no specific information available regarding the use of MUSCLE RUB (menthol, methyl salicylate cream) during pregnancy. As such, the safety of this product in pregnant patients has not been established. There are no known dosage modifications or special precautions indicated for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in women of childbearing potential. It is advisable to exercise caution and consult with a healthcare provider for individualized recommendations.

Lactation

Nursing mothers should exercise caution when using this product due to the potential for excretion in breast milk. There is a risk of infant exposure to the active ingredients, menthol and methyl salicylate, through breastfeeding. It is recommended that nursing mothers consult a healthcare professional before using this product.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 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, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 understanding of the compound's potential effects in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental poisoning. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of safe storage practices to ensure the well-being of all household members.

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 crucial to store the product at a controlled room temperature, maintaining a range of 15° to 30° Celsius (59° to 80° Fahrenheit).

To ensure the integrity of the product, the cap must be closed tightly after each use. Proper handling and storage conditions are vital to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

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)