Extra Strength Cold and Hot Menthol Patch

Description

The Extra Strength Cold & Hot Menthol Patch is designed for topical application. It provides a dual-action effect through the inclusion of menthol, which offers both cooling and warming sensations. The patch is formulated to deliver effective relief for discomfort associated with muscle and joint pain. The product is intended for use as a non-invasive alternative for pain management.

Uses and Indications

This drug is indicated for the temporary relief of minor pain. It is suitable for use in patients experiencing mild discomfort due to various conditions.

Dosage and Administration

For adults and children aged 12 years and older, the following 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 of 8 hours. If necessary, the application may be repeated, but no more than three patches should be used in a 24-hour period. After use, the patch must be discarded, and the pouch should be resealed immediately after opening to maintain product integrity.

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

Contraindications

Use is contraindicated in the following situations:

• Do not apply tightly bandaged or in conjunction with a heating pad, as this may increase the risk of adverse effects.

• Avoid contact with the eyes and mucous membranes to prevent irritation or injury.

• Application to wounds or damaged skin is contraindicated due to the potential for increased absorption and systemic effects.

• Concurrent use with other topical analgesics is not recommended, as this may lead to enhanced side effects or reduced efficacy.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center at 800-222-1222 without delay.

Healthcare providers should counsel patients to discontinue use and seek medical advice under the following circumstances: if the condition worsens, if redness or irritation develops, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be vigilant for signs of skin injury, including pain, swelling, or blistering at the site of application, and report these symptoms promptly.

In cases of ingestion, it is crucial to obtain emergency medical help immediately. The same contact with a Poison Control Center at 800-222-1222 is recommended to ensure appropriate management of the situation.

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, such as pain, swelling, or blistering at the application site, are experienced.

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 optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if such combinations are inadvertently used.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in efficacy and safety profiles compared to older populations.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 breastfeeding safety. 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 breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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.

Postmarketing Experience

Serious burns have been reported in rare cases following the use of products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and pets to prevent accidental ingestion or exposure. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Patients should be informed to stop using the product 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 if symptoms clear up and then recur within a few days. Additionally, patients should seek medical attention 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 be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product. They should also avoid contact with the eyes and mucous membranes, and refrain from applying the product to wounds or damaged skin. Furthermore, patients should not use this product simultaneously with other topical analgesics to prevent potential adverse effects.

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 Extra Strength Cold and Hot Menthol Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)