Equate Cool and Heat

Description

The product is a medicated patch indicated for the relief of pain. It is formulated for topical application and contains active ingredients that contribute to its analgesic properties. The patch is composed of various polymers and adhesives as inactive ingredients, ensuring effective adhesion and stability. It is available in a specific size and shape, facilitating ease of use for patients. The SPL Code for this product is 34089-3.

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 alleviating discomfort due to arthritis, simple backache, strains, sprains, bursitis, tendonitis, bruises, and cramps.

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

Dosage and Administration

Adults and children aged 12 years and older may apply the patch to the affected area as needed, with a maximum frequency of four applications per day. For children under 12 years of age, it is advised to consult a physician prior to use.

For optimal application, healthcare professionals should instruct patients to grasp both ends of the pad firmly and pull at both ends to stretch the pad until the backing separates. The protective film should be removed while applying the pad directly to the site of pain.

Contraindications

The product is contraindicated for application on wounds, damaged skin, 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 heating pads, as these practices may exacerbate skin irritation or lead to other complications.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should be used only as directed by a healthcare professional. Care should be taken to avoid contact with the eyes and mucous membranes, as exposure may lead to irritation. It is contraindicated to apply the product to wounds, damaged skin, or areas of very sensitive skin. Additionally, users should refrain from tightly bandaging the area of application or using a heating pad, as these practices may exacerbate adverse effects.

Patients are advised to discontinue use and consult a healthcare provider if they experience excessive redness or irritation, if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve only to recur within a few days.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or very sensitive areas, and it is advised not to bandage tightly or use a heating pad in conjunction with the application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience excessive redness or irritation, if their condition worsens, if 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.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Equate Cool and Heat (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 aged 12 years and older, the recommended application is to place the patch on the affected area as needed, with a maximum frequency of four times daily.

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

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 on 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 not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

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, 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 and management procedures.

Healthcare providers should ensure that patients are monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

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

No postmarketing experience details are available in the insert text.

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 they experience excessive redness or irritation. Additionally, they should be informed to discontinue use and seek medical advice if their condition worsens or if pain persists for more than 7 days. If symptoms resolve and then recur within a few days, patients should also stop using the product and consult a healthcare professional.

It is important for patients to use the product only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes. Furthermore, patients should not apply the product to wounds, damaged skin, or very sensitive areas. They should also be advised against tightly bandaging the area or using a heating pad while using this product.

Storage and Handling

The product is supplied in packaging that includes 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. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, the patch should be applied to the affected area as needed, with a maximum frequency of four times daily. For children under 12 years, it is advised to consult a doctor before use.

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

Drug Information (PDF)

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

View product document (PDF)