Cold-Hot Medicated Patches

Description

Veridian Healthcare, located in Gurnee, IL 60031, USA, manufactures this product. The large patch label is available in a JPEG image format.

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.

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

Application 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. Healthcare professionals should advise patients to discontinue use and seek medical attention under the following circumstances: if the condition worsens, if redness is observed, if irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

In the event of accidental ingestion, it is imperative to obtain 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 the event of worsening conditions, the presence of redness, the development of irritation, or if symptoms persist for more than 7 days or resolve and then recur within a few days, it is advised to stop use and consult a healthcare professional. These recommendations are crucial for ensuring patient safety and effective management of any adverse reactions that may arise during the use of the product.

Drug Interactions

No drug interactions have been identified for the specified medication. Additionally, there are no interactions noted between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Cold-Hot Medicated Patches (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 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 of these patients.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in managing potential overdosage cases.

Continued vigilance and adherence to recommended dosing guidelines are crucial to minimize the risk of overdosage and ensure patient safety.

Nonclinical Toxicology

No relevant information was found regarding teratogenic or non-teratogenic effects. Additionally, there is no available data pertaining to nonclinical toxicology or animal pharmacology and toxicology.

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 the medication in conjunction with a heating pad, 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 resealable pouches. After opening, it is essential to reseal the pouch to maintain product integrity. The product should be stored at room temperature to ensure optimal quality and effectiveness.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children over 12 years, the patch should be applied to the affected area by carefully removing the backing and placing the sticky side against the skin. Each patch can be worn for up to 8 hours and may be repeated as necessary, not exceeding four applications daily. 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 against tightly bandaging the area or using a heating pad in conjunction with the patch. Contact with eyes and mucous membranes should be avoided, and the patch should not be applied to wounds or damaged skin. Patients should discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, or if symptoms persist beyond 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek advice from a healthcare professional before use.

Drug Information (PDF)

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

View product document (PDF)