Healthwise Cold Therapy Pain Relief Patch

Description

The HealthWise Cold Therapy Pain Relief Patch is designed for effective pain management. The product is represented in an image/jpeg format, with the referenced object being the packaging identified as 59-94915. The effective time for this product is noted as December 1, 2023.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for 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 starting at a corner. The sticky side of the patch must then be applied directly to the affected area.

It is important to note that no more than one patch should be used in an 8-hour period. Patches 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, a physician should be consulted prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Contact with the 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 increased sensitivity or adverse reactions. Concurrent use with other topical analgesics is not advised, as this may lead to enhanced side effects or reduced efficacy.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to stop using the product and consult a physician if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement, or any signs of skin injury, including pain, swelling, or blistering at the application site.

When utilizing this product, it is imperative to adhere strictly to the provided directions. There have been rare reports of serious burns associated with similar products; therefore, caution is advised. Patients should be instructed not to bandage the area tightly or use a heating pad in conjunction with the product. Additionally, contact with the eyes and mucous membranes must be avoided, and the product should not be applied to wounds or damaged skin. It is also essential to inform patients that concurrent use with other topical analgesics is contraindicated.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days. Additionally, individuals should seek medical advice if they experience signs of skin 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 optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if there is a concern about overlapping therapies.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For patients aged 12 years and older, the affected area must be cleaned and dried, ensuring it is free of lotions, ointments, and creams. The backing of the patch should be carefully removed starting at a corner, and the sticky side of the patch should be 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. The pouch should be resealed after opening to maintain integrity.

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 potential for altered pharmacokinetics and pharmacodynamics in 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 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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective 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 limits the assessment of potential risks associated with the use of the compound in question.

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. The nature of these reports suggests a need for continued monitoring and evaluation of the safety profile of the product in the postmarketing setting.

Patient Counseling

Healthcare providers should advise patients to use the product only as directed. It is important to inform patients that there have been rare cases of serious burns associated with products of this type, emphasizing the need for caution during use.

Patients should be instructed not to bandage the area tightly or use the product in conjunction with a heating pad, as this may increase the risk of adverse effects. Additionally, healthcare providers should remind patients to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds or damaged skin.

Furthermore, it is essential to counsel patients against using this product simultaneously with other topical analgesics, as this may lead to increased risk of side effects or diminished effectiveness.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)