Cold Hot Medicated Patch 5% Menthol

Description

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

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 mentioned in the available data.

Dosage and Administration

Adults and children aged 12 years and older 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 applied directly to the affected area.

No more than one patch should be used within an 8-hour period, and the application may be repeated as necessary, with a maximum of three patches permitted per day. Each patch is for single use only and must 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, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on infants is prohibited.

• The product should not be used if the condition worsens, if redness is present, or if irritation develops.

• Discontinue use if symptoms persist for more than 7 days or if symptoms clear up and recur within a few days.

• Signs of injury, such as pain, swelling, or blistering at the application site, indicate that the product should not be used.

• Avoid tight bandaging or the use of heating pads in conjunction with this product.

• Contact with eyes and mucous membranes must be avoided.

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

• Concurrent use with other topical analgesics is contraindicated.

Warnings and Precautions

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

In the event of accidental ingestion, it is imperative to obtain emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if the condition worsens, if redness is present, or if irritation develops. Additionally, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought. Patients are also advised to seek medical attention if they experience signs of injury, 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 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 if they are infants. In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

For children aged 12 years and older, the recommended application 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. No more than one patch should be used in an 8-hour period, with a maximum of three patches allowed per day. Each patch is for single use only and should be discarded after application, with the pouch resealed after opening.

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

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. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 on 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 and consider the potential implications of excessive dosing.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdosage scenario. Symptoms may vary depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is advisable to consult local poison control centers or relevant medical authorities for guidance on management protocols tailored to the specific situation.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management 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 compound in these areas.

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 help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if redness occurs, or if irritation develops. Additionally, if symptoms persist for more than 7 days or if they resolve and then recur within a few days, patients should stop using the product and seek medical advice. Signs of injury, such as pain, swelling, or blistering at the application site, should also prompt patients to stop use and consult a healthcare professional.

It is essential to emphasize that patients must use the product only as directed. They should be made aware of the rare possibility of serious burns associated with similar products. Patients should avoid tightly bandaging the area of application or using a heating pad concurrently.

Healthcare providers should remind patients to avoid contact with eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin. Furthermore, patients should not use this product simultaneously with other topical analgesics.

Storage and Handling

The product is supplied in a pouch that must be resealed after opening to maintain integrity. It is essential to store the product at room temperature. Each patch is intended for single use only and should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically, with a recommendation to use no more than one patch within an 8-hour period, allowing for a maximum of three patches per day as needed. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is crucial to keep the product out of reach of children and to avoid application 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.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

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)