Rugby Menthol Hot Cold Patch

Description

Rugby Menthol Cold / Hot Patch is a topical formulation designed for the relief of muscle and joint discomfort. The patch utilizes menthol as its active ingredient, providing both cooling and warming sensations to alleviate pain. The effective time for this product commenced on July 1, 2021. The patch is designed for easy application and is intended for external use only.

Uses and Indications

This drug is indicated for targeted, long-lasting pain relief.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 years and older, the following dosage and administration instructions should be adhered to:

Carefully remove the backing from the patch. The sticky side of the patch should be applied directly to the affected area. Each patch may be worn for a maximum duration of 8 hours. If necessary, the application may be repeated; however, it should not exceed three applications within a 24-hour period. After each use, the patch must be discarded, and the pouch should be resealed to maintain integrity.

For children under 12 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on infants is prohibited due to safety concerns.

• The product should not be applied to wounds or damaged skin to prevent adverse effects.

• Avoid contact with the eyes and mucous membranes to reduce the risk of irritation.

• Do not use in conjunction with other topical analgesics, as this may increase the risk of side effects.

• Tight bandaging or the use of heating pads in conjunction with this product is not recommended, as it may lead to increased absorption and potential toxicity.

• In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center (800-222-1222) is advised.

Warnings and Precautions

For external use only. Healthcare professionals should be aware that rare cases of serious burns have been reported with products of this type. It is essential to advise patients against bandaging the area tightly or using a heating pad in conjunction with the product.

Contact with the eyes and mucous membranes must be avoided to prevent irritation or injury. The product should not be applied to wounds or damaged skin, and concurrent use with other topical analgesics is contraindicated to minimize the risk of adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (800-222-1222) should be contacted without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement, or any signs of skin injury, including pain, swelling, or blistering at the application site.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and recur within a few days, or if signs of skin injury are experienced, such as pain, swelling, or blistering at the site of application.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and efficacy of treatment. Monitoring for any signs of irritation or adverse reactions is recommended if there is a need to switch to or from another topical analgesic.

Packaging & NDC

Below are the non-prescription pack sizes of Rugby Menthol Hot Cold Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should be evaluated by a physician prior to use. The product is contraindicated in infants. Caution is advised when considering treatment options for 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 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 consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure safe use during pregnancy and lactation.

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

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

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.

If available, specific antidotes or treatments should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for guiding treatment decisions and ensuring patient safety.

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 these contexts.

Postmarketing Experience

Rare cases of serious burns have been reported in association with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients that this product is not intended for use on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

When using this product, patients must be reminded to use it only as directed. It is important to note that rare cases of serious burns have been reported with similar products. Patients should avoid tightly bandaging the area or using a heating pad in conjunction with the product. They should also be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. Furthermore, patients should be informed not to use this product simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Rugby Menthol Hot Cold Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)