Hot and Cold Medicated Patch

Description

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

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including 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 four 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 the following situations:

Tight bandaging or application with a heating pad is not recommended, as this may lead to adverse effects. Additionally, contact with the eyes and mucous membranes should be strictly avoided to prevent irritation or injury. The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or hinder healing.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

In the event of accidental ingestion, patients should be instructed to seek emergency medical help or contact a Poison Control Center immediately.

General precautions must be emphasized to ensure safe use. Patients should use the product only as directed and avoid tightly bandaging the area or using it in conjunction with a heating pad. It is crucial to prevent contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin.

No specific laboratory tests are recommended for monitoring in relation to this product.

Side Effects

Patients should be aware that the product is for external use only. In clinical practice, it is advised that patients discontinue use and consult a healthcare professional under certain circumstances. Specifically, patients should seek medical advice if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days. These recommendations are based on clinical observations and are intended to ensure patient safety and effective management of their condition.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Hot and Cold Medicated Patch (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 12 years of age or younger should be evaluated by a physician prior to use. It is essential to consider the specific needs and potential risks associated with this age group when determining treatment options.

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 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 to weigh the benefits and risks associated with the use of this medication 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. 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. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to use the medication only as directed. It is important to emphasize that patients should not bandage the area tightly or use the medication in conjunction with a heating pad, as this may lead to adverse effects.

Patients should be informed to avoid contact with the eyes and mucous membranes to prevent irritation or injury. Additionally, healthcare providers should instruct patients not to apply the medication to wounds or damaged skin, as this could compromise healing or exacerbate the condition.

Storage and Handling

The product is supplied in a resealable pouch, which should be securely resealed after each use to maintain product integrity. It is essential to keep the product out of reach of children to ensure safety during storage and handling.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children over 12 years. Patients should carefully remove the backing from the patch and apply the sticky side to the affected area, wearing the patch for up to 8 hours. It may be repeated as necessary, but no more than four times daily. For children aged 12 years or younger, consultation with a physician is advised.

Clinicians should counsel patients to use the product only as directed, avoiding tight bandaging or use with heating pads, and to prevent contact with eyes and mucous membranes. The product should not be applied to wounds or damaged skin. Patients are advised to discontinue use and consult a doctor if the condition worsens, if redness or irritation occurs, or if symptoms persist beyond 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek advice from a health professional prior to use.

Drug Information (PDF)

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

View product document (PDF)