Extra Large Cool and Heat Patch

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided.

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, muscle sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children over 12 years of age 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 applied in a 24-hour period. After opening, the pouch should be resealed to maintain the integrity of the remaining patches.

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

Contraindications

Use of this product is contraindicated in infants.

Application should not occur on wounds or damaged skin, and it is advised to avoid contact with eyes and mucous membranes. The product should not be used concurrently with other topical analgesics. Additionally, do not apply tightly bandaged or in conjunction with a heating pad, as this may exacerbate adverse effects.

If any of the following conditions occur, discontinue use and consult a healthcare professional: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, recurrence of symptoms after resolution, or signs of skin injury such as pain, swelling, or blistering at the application site.

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 800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician 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 initial improvement. Additionally, patients should seek medical attention if they experience signs of skin injury, including 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 healthcare professional 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 signs of increased local irritation or systemic effects is recommended if there is any uncertainty regarding the use of concomitant topical therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Large Cool and Heat Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children to prevent accidental ingestion. The use of this medication is not recommended for infants. For children aged 12 years or younger, it is advised to consult a physician prior to use to ensure safety and appropriateness of treatment.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before 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 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the implementation of specific antidotes or interventions may be warranted based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the appropriate management strategies tailored to the individual case.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients not to use this product on infants. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 800-222-1222.

Patients should be informed to monitor their condition closely. They should report to their healthcare provider if their condition worsens, if redness is present, or if irritation develops. Additionally, patients should be instructed to seek medical advice if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days. Signs of skin injury, such as pain, swelling, or blistering at the application site, should also prompt immediate consultation with a healthcare professional.

It is essential to emphasize that patients must use the product only as directed. They should be made aware of the rare but serious risk of burns associated with products of this type. Patients should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the product.

Healthcare providers should 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 be advised not to use this product simultaneously with other topical analgesics to prevent potential adverse effects.

Storage and Handling

The product is supplied in pouches that must be resealed after opening to maintain integrity. It is essential to discard any unused portion after opening to ensure safety and efficacy. The product should be stored at room temperature, away from direct sunlight and moisture, to preserve its quality.

Additional Clinical Information

The product is administered topically, with a recommended usage of one patch for adults and children over 12 years, applied for up to 8 hours. Patients may repeat this application as necessary, but should not exceed three applications in a single day.

Clinicians should counsel patients on the proper use of the product, emphasizing adherence to directions to minimize risks. Patients should be informed of rare but serious burn incidents associated with topical analgesics and advised against tight bandaging or the use of heating pads in conjunction with the patch. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. Patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, if redness or irritation occurs, if symptoms persist beyond 7 days, or if signs of skin injury develop. Pregnant or breastfeeding patients should seek advice from a healthcare provider prior to use.

Drug Information (PDF)

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

View product document (PDF)