Walgreens Cool N Heat Back Patch

Description

No description information is available for the specified drug.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply the patch as follows: First, remove the backing from the patch by firmly grasping both ends and gently pulling until the backing separates in the middle. Next, place the exposed portion of the patch backing onto the affected area and press it firmly against the skin. Carefully remove the remaining film while continuing to press the patch firmly on the skin. The patch should be applied to the affected area no more than 3 to 4 times daily, with one patch used per application. After use, the patch must be discarded, and the pouch should be resealed immediately. It is essential to wash hands thoroughly after both applying and removing the patch.

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

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to wounds or on irritated or damaged skin due to the potential for exacerbating the condition. Additionally, the use of a heating pad in conjunction with this product is contraindicated, as it may lead to increased risk of adverse effects. Furthermore, individuals with known allergies to any ingredients in this product should avoid its use to prevent allergic reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or on irritated or damaged skin. It should not be used in conjunction with a heating pad. Additionally, individuals with known allergies to any ingredients in this product should refrain from its use.

Healthcare professionals are advised to instruct patients to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; there is the presence of redness or excessive irritation; or if the patient experiences severe burning, pain, swelling, or blistering at the site of application.

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

Side Effects

Patients using this product may experience a transient burning sensation upon application, which typically resolves within several days. It is important to note that this product is for external use only and should not be applied to wounds or on irritated or damaged skin. Additionally, it should not be used in conjunction with a heating pad.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; redness or excessive irritation develops; or if severe burning, pain, swelling, or blistering occurs at the application site.

Patients with known allergies to any ingredients in this product should avoid its use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Walgreens Cool N Heat Back 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 adolescents and children aged 12 years and older, the recommended dosage is one patch per application, with a maximum of 3 to 4 applications daily.

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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms is essential, although specific symptoms related to this overdosage may not be detailed in the provided information.

Management procedures should include supportive care and symptomatic treatment as necessary, guided by the clinical presentation of the patient. It is advisable to follow established protocols for managing overdosage cases, ensuring that all actions taken are in accordance with current medical guidelines and recommendations.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or on irritated or damaged skin. Additionally, they should be cautioned against using the product in conjunction with a heating pad. It is important to ensure that patients are aware of any allergies they may have to the ingredients of this product, as it should not be used if they are allergic.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to seek medical advice if symptoms resolve and then recur within a few days. Furthermore, patients should be informed to discontinue use and consult a healthcare professional if they experience redness, excessive irritation, severe burning, pain, swelling, or blistering at the application site.

When using this product, patients should be reminded to follow the directions carefully. They should avoid bandaging the area tightly and should take care to prevent contact with the eyes or mucous membranes. Patients should also be advised against exposing the treated area to local heat or direct sunlight. It is normal for a transient burning sensation to occur upon application, but this typically resolves within several days. Lastly, patients should be cautioned to avoid applying the product into skin folds.

Storage and Handling

The product is supplied in packaging that adheres to the National Drug Code (NDC) specifications. It is essential to store the product at a temperature range of 20-25°C (68-77°F). The storage location should be a cool, dry place, ensuring that the product is kept away from direct sunlight to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Walgreens Cool N Heat Back Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)