Cold Hot Medicated Patch 5% Menthol

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various musculoskeletal conditions, including arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises, and cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and over should begin by cleaning and drying the affected area, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed, and the sticky side of the patch should be applied directly to the affected area.

It is important to note that no more than one patch should be used within an 8-hour period. Patches may be reapplied as necessary, but the maximum allowable usage is three patches per day. Each patch is for single use only and should be discarded after application. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

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

Contraindications

Use is contraindicated in the following situations:

• Application on infants is prohibited due to the potential for adverse effects.

• Tight bandaging or concurrent use with heating pads is not recommended, as this may exacerbate local irritation or discomfort.

• Contact with eyes and mucous membranes must be avoided to prevent irritation or injury.

• Application to wounds or damaged skin is contraindicated to avoid further tissue damage or infection.

• Concurrent use with other topical analgesics is not advised, as this may increase the risk of systemic absorption and potential side effects.

Warnings and Precautions

For external use only. This product is contraindicated in infants. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens; if redness or irritation develops; if symptoms persist for more than 7 days; if symptoms resolve and then recur within a few days; or if any signs of injury occur, such as pain, swelling, or blistering at the site of application.

In cases of ingestion, it is imperative to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event of worsening conditions, the presence of redness, or the development of irritation, it is advised to discontinue use and consult a healthcare professional. Additionally, if symptoms persist for more than 7 days, or if they resolve and then recur within a few days, patients should seek medical advice.

Patients should also be vigilant for signs of injury at the application site, which may include pain, swelling, or blistering. In such cases, it is crucial to stop using the product and contact a doctor for further evaluation and guidance.

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 advisable to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimize treatment efficacy. 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 Cold Hot Medicated Patch 5% Menthol (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product on infants. For children under 12 years of age, consultation with a physician is advised prior to use.

For adolescents and children aged 12 years and older, the application process involves cleaning and drying the affected area, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed, and the sticky side applied to the affected area. It is important to limit use to one patch within an 8-hour period, with a maximum of three patches per day. Each patch is for single use only and should be discarded after application. The pouch should be resealed after opening to maintain product integrity.

Healthcare professionals should ensure that this product is kept out of reach of children.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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.

Additionally, the use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion of the substance is confirmed.

For specific management protocols, healthcare professionals should refer to established guidelines and consult poison control centers as necessary. Continuous assessment and supportive care remain critical in managing any overdose situation effectively.

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 with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients not to use this product on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if redness occurs, if irritation develops, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, they should seek medical attention if they experience signs of injury, such as pain, swelling, or blistering at the site of application.

It is essential to instruct patients to use the product only as directed. They should be made aware that rare cases of serious burns have been reported with similar products. Patients should also be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes, and patients should be advised not to apply the product to wounds or damaged skin. Furthermore, patients should be informed that this product should not be used simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in a pouch that must be resealed after opening to maintain integrity. Each patch is intended for single use only and should be discarded after use to ensure safety and efficacy.

For optimal storage, it is recommended to keep the product in a cool, dry place, away from direct sunlight and moisture. Specific temperature ranges for storage are not provided; however, general guidelines for similar products suggest maintaining a temperature between 20°C to 25°C (68°F to 77°F). Proper handling is essential to preserve the quality of the patches.

Additional Clinical Information

The route of administration for the medication is topical. Clinicians should advise patients not to use more than one patch within an 8-hour period, with a maximum of three patches allowed per day.

Patients should be counseled to consult a healthcare professional if they are pregnant or breastfeeding before using the product. It is crucial to keep the medication out of reach of children and to avoid use on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Cold Hot Medicated Patch 5% Menthol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)