Cold Hot Medicated Patch 5% Menthol

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the opposite side. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various 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 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. The patch may be reapplied as necessary, with a maximum of three patches permitted 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 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.

• Avoid application in the presence of signs of injury, such as pain, swelling, or blistering at the site of application.

• Do not apply tightly bandaged or in conjunction with a heating pad.

• 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 consultation 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

Patients should be aware that the product 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, medical advice should be sought.

Patients should also be vigilant for signs of injury at the application site, which may include pain, swelling, or blistering. If any of these symptoms occur, it is important to stop using the product and contact a doctor for further evaluation.

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 signs of irritation or systemic effects is recommended if there is any uncertainty regarding the use of multiple agents.

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 affected area should be cleaned and dried, 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 permitted 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.

It is essential to keep this product 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 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 prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

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 drug 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 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.

Recommended Actions

In the event of suspected overdosage, it is essential to monitor the patient closely for any adverse effects. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation.

Potential Symptoms

While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise following administration.

Management Procedures

Management of overdosage should be tailored to the individual patient, taking into account their medical history and the context of the overdose. Consultation with a poison control center or a medical toxicologist may be beneficial in guiding treatment decisions.

In summary, due to the lack of detailed overdosage information, healthcare providers should prioritize patient safety through careful monitoring and supportive care in cases of suspected overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Rare cases of serious burns have been reported in postmarketing experience 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 informed to discontinue use and consult a doctor if their condition worsens, if redness occurs, or if irritation develops. They should also be instructed to stop using the product if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days. Additionally, if patients experience signs of injury, such as pain, swelling, or blistering at the application site, they should cease use and seek medical advice.

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 products of this type. Patients should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product.

Healthcare providers should instruct patients to avoid contact with the eyes and mucous membranes and to refrain from applying the product to wounds or damaged skin. Furthermore, patients should be advised not to 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. Each patch is intended for single use only and should be discarded after use. It is recommended to store the product at room temperature to ensure optimal performance.

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 repetition as necessary, with a maximum of three patches per day.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before 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.

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)