Cvs Health Cooling Patch

Description

The product is identified by SPL code 34089-3 and is classified as a cold therapy patch. Each patch contains a proprietary gel formulation specifically designed for effective cold therapy. These patches are intended for single use and are packaged in a box containing 10 individual patches. The product is designated for external use only.

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, 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, and the sticky side of the patch should be applied directly to the affected area. No more than one patch should be used within an 8-hour period, and it may be repeated as necessary. The maximum allowable dosage is three patches per day. Each patch is for single use only and should be discarded after application.

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

Contraindications

Use is contraindicated in infants.

Application should not involve tight bandaging or the use of heating pads, as this may exacerbate adverse effects. Contact with eyes and mucous membranes must be avoided to prevent irritation. The product should not be applied to wounds or damaged skin due to the risk of further injury or infection. Concurrent use with other topical analgesics is contraindicated to avoid potential interactions and increased risk of side effects.

Warnings and Precautions

For external use only. This product is contraindicated for use on infants. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and seek medical consultation under the following circumstances: if the condition worsens, if redness occurs, if irritation develops, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to seek medical attention if they experience signs of skin injury, which may include pain, swelling, or blistering at the site of application.

In cases of ingestion, it is imperative to obtain emergency medical help or contact a Poison Control Center immediately.

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 efficacy of treatment. Monitoring for any signs of irritation or adverse reactions is recommended if there is a need to switch to or from another topical analgesic.

Packaging & NDC

Below are the non-prescription pack sizes of Cvs Health Cooling 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. The product is not indicated for infants. It is essential to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center at 1-800-222-1222.

For adolescents aged 12 years and older, the recommended application involves cleaning and drying the affected area, ensuring it is free of lotions, ointments, and creams. The sticky side of the patch should be applied to the affected area, with a maximum of one patch used for up to an 8-hour period. The patch may be repeated as necessary, but no more than three patches should be used in a single day. Each patch is for single use only and should be discarded after application.

Geriatric Use

There is no specific information available 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. 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 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 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 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 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 relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Rare cases of serious burns have been reported in postmarketing experience with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients that this product is not intended for use 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 a healthcare professional 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.

It is essential for patients to use the product only as directed. Providers should inform patients that there have been rare reports of serious burns associated with similar products. Patients should be cautioned against tightly bandaging the area where the product is applied or using it in conjunction with a heating pad.

Healthcare providers should emphasize the importance of avoiding contact with the eyes and mucous membranes, and patients should be advised not to apply the product to wounds or damaged skin. Furthermore, patients should be informed that this product should not be used 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 86ºF (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 Cvs Health Cooling Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)