Rugby Muscle Rub Cream

Description

Rugby Greaseless MUSCLE RUB Cream is a topical analgesic formulation containing 10% menthol and 15% methyl salicylate. This product is designed for external use to provide relief from muscle and joint discomfort. The cream is packaged in a net weight of 3.0 ounces (85 grams).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscle and joint conditions, including simple backaches, arthritis, strains, bruises, and sprains.

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. For children under 2 years of age, it is advised to consult a doctor prior to use.

Healthcare professionals should instruct patients to wash their hands thoroughly with soap and water immediately after application, unless the treatment area involves the hands themselves. This practice helps to prevent unintentional transfer of the medication to other areas of the body or to other individuals.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and mucous membranes to prevent irritation or injury. In the event that conditions worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted.

This product must not be applied to wounds or damaged skin. Additionally, it is advised not to apply a bandage tightly over the treated area, nor should it be used in conjunction with a heating pad. Application on wounds, damaged, broken (open), or irritated skin is contraindicated. Should excessive irritation of the skin develop, the use of the product should be discontinued immediately.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to use. A temporary burning sensation may occur upon application; however, this sensation typically subsides within a few days. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only and must avoid contact with eyes and mucous membranes. In clinical use, a temporary burning sensation may occur upon application; however, this sensation typically resolves within a few days.

Serious adverse reactions may arise if the product is applied to wounds, damaged, broken (open), or irritated skin. Patients are advised to discontinue use if excessive irritation of the skin develops. Additionally, if conditions worsen or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional.

It is important to note that the product should not be used in conjunction with a heating pad or applied tightly with a bandage. Pregnant or breastfeeding patients should seek advice from a healthcare professional prior to use.

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 Rugby Muscle Rub Cream (muscle rub cream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Healthcare professionals should ensure that this medication, like all drugs, is kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of Rugby Muscle Rub Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. As such, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be prudent in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. 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 specific NDC numbers, which are essential for identification and inventory management. It should be stored at a controlled room temperature, maintained between 68°F to 77°F (20°C to 25°C).

To ensure the integrity of the product, it is important to close the cap tightly after each use. Proper handling and storage conditions are crucial for maintaining the quality and efficacy of the product.

Additional Clinical Information

The product 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 of age, consultation with a healthcare professional is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is crucial to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)