Muscle Rub

Description

MUSCLE RUB GEL is a topical formulation designed for application to the skin. The product is packaged in a net weight of 1.25 ounces (35 grams).

Uses and Indications

This drug is indicated for the soothing relief of minor arthritis pain, as well as discomfort associated with aching muscles, joints, and backaches.

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 dosage is to apply the gel to the affected area no more than 3 to 4 times daily. The gel should be gently massaged into the skin until it is fully absorbed and disappears.

For children under 12 years of age, the use of this product is not recommended. Consultation with a healthcare professional is advised prior to use in this age group.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be applied strictly as directed. It is imperative to keep the product out of reach of children to prevent accidental poisoning. Healthcare professionals should advise patients to avoid contact with the eyes or mucous membranes to prevent irritation.

In the event of excessive skin irritation, the use of the product should be discontinued immediately. It is also important to instruct patients not to bandage the area tightly, apply the product to wounds, broken or irritated skin, or use it in conjunction with a heating pad, as these practices may exacerbate adverse effects.

Should the condition worsen, or if symptoms persist beyond 10 days, or if symptoms resolve and then recur within a few days, patients are advised to discontinue use and consult a physician. Additionally, if any skin redness or irritation develops, medical consultation is recommended.

This product is contraindicated for use in children under 12 years of age for arthritis-like conditions; a healthcare professional should be consulted in such cases. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product may experience a range of adverse reactions, which should be monitored closely.

Serious adverse reactions include excessive skin irritation, which necessitates discontinuation of use. In cases where the condition worsens, symptoms persist beyond 10 days, or if skin redness or irritation develops, patients are advised to discontinue use and consult a healthcare professional.

Common adverse reactions may arise from improper application, such as contact with eyes or mucous membranes, which should be strictly avoided. Additionally, patients should refrain from using the product on wounds, broken or irritated skin, or in conjunction with a heating pad, as these practices may exacerbate irritation.

It is crucial to keep this product out of reach of children to prevent accidental poisoning. For children under 12 with arthritis-like conditions, consultation with a doctor is recommended prior to use.

Drug Interactions

There are no documented drug interactions associated with this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication for arthritis-like conditions without consulting a healthcare professional. It is essential for caregivers to seek medical advice before administering this treatment to children in this age group.

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 information available regarding the use of Muscle Rub - menthol gel during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should exercise caution when recommending this product to pregnant patients due to the lack of data on potential risks or fetal impacts. It is advisable to consider alternative therapies that have established safety profiles in pregnant women.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that includes a unique Lot Number and Expiration Date, which can be found on the crimp of the tube.

It is essential to store the product at a controlled room temperature, maintaining a range of 15°C to 30°C (59°F to 86°F) to ensure its stability and efficacy. Proper handling and storage conditions must be adhered to in order to preserve the integrity of the product.

Additional Clinical Information

For adults and children aged 12 years and older, the recommended administration involves applying the gel to the affected area no more than 3 to 4 times daily, with gentle massage until the gel is fully absorbed. For children under 12 years of age, it is advised to consult a doctor before use.

No further information is available regarding laboratory tests, abuse potential, 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)