Wellpatch Cooling Pain Relief

Description

WellPatch Cooling Pain Relief Patch is a topical dosage form designed for localized pain relief. The patch provides a cooling sensation upon application, which aids in alleviating discomfort. It is formulated to adhere securely to the skin, ensuring prolonged contact with the affected area for effective pain management. The product is intended for use in various pain conditions, offering a convenient and non-invasive option for patients seeking relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, specifically due to conditions such as simple backache, arthritis, strains, and sprains.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older should apply the patch to the affected area, with a recommended frequency of changing the patch 1 to 2 times daily. For children under 12 years of age, it is advised to consult a physician prior to use.

For optimal results, the patch should be applied to clean, dry skin. To prepare the patch for application, the healthcare professional should tear open the pouch and remove the patch. If necessary, the patch may be cut to size before application.

When applying the patch, the user should grasp both ends firmly with their thumbs near the center and stretch the patch until the backing separates. The protective film should then be removed, allowing the patch to be applied directly to the site of pain.

Contraindications

The product is contraindicated for application to wounds or damaged or very sensitive skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging or in conjunction with a heating pad, as this may increase the risk of skin irritation or other complications.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. It is imperative that the product is not applied to wounds, damaged skin, or areas of very sensitive skin. Additionally, patients should be cautioned against tightly bandaging the area of application or using the product in conjunction with a heating pad.

Patients should be instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens; excessive redness, irritation, burning, or discomfort of the skin develops; pain persists for more than 7 days; or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience adverse reactions, which can vary in severity. It is important to note that this product is for external use only and should be applied strictly as directed.

Common adverse reactions include excessive redness, irritation, burning, or discomfort of the skin. In clinical observations, participants have reported these symptoms, particularly when the product is applied to sensitive areas or inappropriately to wounds or damaged skin.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, development of excessive redness, irritation, burning, or discomfort, persistence of pain beyond 7 days, or if symptoms resolve and then recur within a few days.

Additionally, it is recommended to avoid contact with eyes and mucous membranes, and to refrain from tightly bandaging the area or using the product in conjunction with a heating pad, as these practices may exacerbate adverse reactions.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area, with the patch being changed 1 to 2 times daily. It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is currently no information available regarding the use of WELLPATCH COOLING PAIN RELIEF (menthol patch) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and discuss potential risks and benefits with their patients. Further studies may be necessary to establish the safety profile of this product in pregnant individuals.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding or effects on breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens or if they experience excessive redness, irritation, burning, or discomfort of the skin. Additionally, they should be informed to discontinue use and seek medical advice if pain persists for more than 7 days or if symptoms resolve and then recur within a few days.

It is essential to emphasize that patients should use the product only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes during application. Furthermore, patients should not apply the product to wounds or to damaged or very sensitive skin. They should also be advised against bandaging the area tightly or using the product in conjunction with a heating pad.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The medication is administered topically, with specific instructions for different age groups. For adults and children aged 12 years and older, the patch should be applied to the affected area and changed 1 to 2 times daily. For children under 12 years, it is advised to consult a doctor before use.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)