Hot and Cold Medicated Patch

Description

Veridian Healthcare, LLC, located in Gurnee, IL 60031, is the manufacturer of this product. For inquiries, a toll-free customer care help line is available Monday through Friday from 8:30 am to 4:30 pm CST at 866-326-1313.

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 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 no more than four patches should be applied 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 the application of a heating pad in conjunction with this product is not recommended, as it may lead to adverse effects. Additionally, contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury. The application of this product to wounds or damaged skin is contraindicated due to the potential for exacerbating the condition or causing further harm.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging the area tightly or using it in conjunction with a heating pad, as this may lead to adverse effects. Care should be taken to prevent contact with the eyes and mucous membranes, as exposure can result in irritation or injury. Additionally, the product must not be applied to wounds or damaged skin to avoid complications.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist beyond 7 days or reappear shortly after resolution. These precautions are essential to ensure patient safety and to mitigate potential adverse reactions.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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 be evaluated by a physician prior to use. It is essential to consider the specific needs and health status of this age group to ensure appropriate care and treatment.

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 weighed, 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 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate 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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients that they should monitor their condition closely and report to their healthcare provider if any of the following occur: worsening of their condition, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

Patients should be instructed to use the product only as directed. They should be cautioned against bandaging the area tightly or using the product in conjunction with a heating pad. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes, and they should advise patients not to apply the product to wounds or damaged skin.

Storage and Handling

The product is supplied in pouches that should be stored at room temperature. After opening, it is essential to reseal the pouch to maintain product integrity. Additionally, the product must be kept out of reach of children to ensure safety.

Additional Clinical Information

The route of administration for the medication is topical. Patients aged 12 years and older should apply one patch for up to 8 hours, with the option to repeat this process as necessary, not exceeding four applications in a 24-hour period.

Clinicians should counsel patients to use the medication only as directed. It is important to avoid tight bandaging or the use of heating pads in conjunction with the patch. Patients should also be advised to prevent contact with eyes and mucous membranes, and to refrain from applying the patch to wounds or damaged skin. Additionally, individuals who are pregnant or breastfeeding should consult a healthcare professional prior to use.

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)