Hot and Cold Medicated Patch

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, povidone, talc, 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 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 over 12 years of age should carefully remove the backing from the patch and apply the sticky side directly to the affected area. Each patch may be worn for a maximum of 8 hours. If necessary, the application may be repeated, but it should not exceed 4 patches in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

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

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or application with a heating pad is not recommended, as this may lead to adverse effects. Additionally, contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury. The product should not be applied to wounds or damaged skin, as this may compromise healing and increase the risk of complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances: if the condition worsens, if redness occurs, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for external use only. In clinical practice, it is advised that patients discontinue use and consult a healthcare professional under certain circumstances. Specifically, patients should seek medical advice if their condition worsens, if they experience redness, if irritation develops, or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, patients are also encouraged to stop use and consult a doctor. These precautions are important to ensure the safety and well-being of patients using the product.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger 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 dosage and safety profiles compared to older populations.

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 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 regarding 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 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 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 the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed. It is important to emphasize that patients should not bandage the area tightly or use a heating pad in conjunction with the medication, as this may lead to adverse effects.

Patients should be informed to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, healthcare providers should instruct patients not to apply the medication to wounds or damaged skin, as this could compromise healing or exacerbate the condition.

Storage and Handling

The product is supplied in a pouch that must be resealed after opening to maintain its integrity. It should be stored at room temperature to ensure optimal quality. Additionally, it is important to keep the product out of reach of children to prevent accidental ingestion.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children over 12 years, the patch should be applied by carefully removing the backing and placing the sticky side on the affected area. Each patch can be worn for up to 8 hours, with a maximum of 4 applications per day. For children aged 12 years or younger, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to use the medication only as directed. Patients are advised not to bandage the area tightly or use a heating pad in conjunction with the patch. It is important to avoid contact with eyes and mucous membranes, and the patch should not be applied to wounds or damaged skin. Pregnant or breastfeeding patients should seek advice from a health professional before using the product.

Drug Information (PDF)

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

View product document (PDF)