Walgreens Cold Therapy Pain Relief Patch

Description

Walgreens Cold Therapy Pain Relief Patch 5S is designed for localized pain relief through cold therapy. The product is intended for use in managing pain associated with various conditions. The effective time for this patch is noted as August 1, 2022.

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 the management of discomfort related to 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 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 three patches should be used in a 24-hour period. After each use, the patch must be discarded, and the pouch should be resealed to maintain product integrity.

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:

Infants should not be treated with this product due to the potential for adverse effects.

The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Additionally, it is contraindicated for use on mucous membranes and in the eyes to prevent serious irritation or injury.

Tight bandaging or the use of heating pads or devices in conjunction with this product is not recommended, as this may increase the risk of skin irritation or burns.

Concurrent use with other topical analgesics is contraindicated to avoid potential additive effects and increased risk of adverse reactions.

In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should be aware that rare cases of serious burns have been reported with similar products. It is imperative to avoid tight bandaging and the use of heating pads or devices in conjunction with this product, as these practices may exacerbate the risk of adverse effects.

Contact with the eyes and mucous membranes should be strictly avoided. Additionally, the product should not be applied to wounds or damaged skin, nor should it be used concurrently with other topical analgesics, as this may lead to increased risk of irritation or other complications.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after a temporary improvement. Signs of skin injury, such as pain, swelling, or blistering at the application site, also warrant immediate medical consultation.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center (1-800-222-1222) without delay.

Side Effects

Patients using this product should be aware that it is for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of adhering to the recommended usage guidelines. It is advised not to bandage the area tightly or use the product in conjunction with heating pads or devices, as this may increase the risk of adverse reactions.

Contact with the eyes or mucous membranes should be strictly avoided, and the product should not be applied to wounds or damaged skin. Additionally, concurrent use with other topical analgesics is not recommended, as this may lead to increased risk of adverse effects.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, 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 efficacy of treatment. Monitoring for any signs of increased irritation or adverse reactions is recommended if there is a need to transition between topical analgesics.

Packaging & NDC

Below are the non-prescription pack sizes of Walgreens Cold Therapy Pain Relief Patch (menthol 5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should not use this product, particularly infants, as it is not indicated for this age group. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

For children aged 12 years and older, the recommended application involves carefully removing the backing from the patch and applying the sticky side to the affected area. The patch may be worn for up to 8 hours and can be repeated as necessary, not exceeding three applications in a 24-hour period. After use, the patch should be discarded, and the pouch resealed. For children under 12 years of age, consultation with a physician is advised prior to use.

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 efficacy, 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug 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.

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 overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the available data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

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 does not imply a causal relationship, and further investigation may be warranted to understand the context of these occurrences.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and to avoid using it on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed to discontinue use and consult their doctor if any of the following occur: the condition worsens, redness develops, irritation occurs, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

When using this product, patients must be reminded to use it only as directed. They should be made aware that there have been rare reports of serious burns associated with similar products. Patients should not bandage the area tightly or use a heating pad or device in conjunction with the product. It is also important to instruct patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin. Furthermore, patients should not use this product simultaneously with other topical analgesics.

Storage and Handling

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

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)