Hot/Cold Medicated Patch

Description

Cold Hot Medicated Patch 1450 is a topical dosage form designed for the relief of pain. The patch is formulated to provide both cooling and warming sensations upon application. It is intended for external use and is characterized by its adhesive backing, which allows for secure placement on the skin. The product is designed to deliver active ingredients effectively to the targeted area, promoting localized relief.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints due to various conditions, including arthritis, simple backache, strains, sprains, and bruises.

Limitations of Use: There are no noted 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 prior to application. A single patch should be removed from its film and applied directly to the skin over the affected area. The recommended dosage is one patch at a time, with a maximum of 3 to 4 applications per day. Each patch should be worn for no longer than 8 hours.

For children under 12 years of age, it is advised to consult a healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse effects.

• Concurrent use with a heating pad is contraindicated as it may lead to excessive heat and increase the risk of burns or skin damage.

• Individuals with known allergies to any ingredients in this product should not use it, as this may result in allergic reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. Individuals with known allergies to any of the product's ingredients should refrain from use.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Care should be taken to avoid contact with the eyes, mucous membranes, or any rashes.

Users are advised to discontinue use and consult a healthcare professional if excessive redness or irritation occurs, if the condition worsens, or if symptoms persist beyond 7 days or reappear shortly after resolution.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on wounds or damaged skin and should not be used in conjunction with a heating pad. Individuals with known allergies to any ingredients in this product should refrain from use.

During the application of this product, it is essential to follow the directions provided. Patients should avoid contact with the eyes, mucous membranes, or any rashes.

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

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Hot/Cold Medicated Patch (hot cold patch). 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 dosage is to apply 1 patch at a time to the affected area, with a maximum of 3 to 4 applications daily. Each patch should be worn for no longer than 8 hours.

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 potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use 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 mothers.

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 patients 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 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 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

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin, as this may lead to adverse effects.

Patients should be informed that the product should not be used in conjunction with a heating pad, as this may increase the risk of side effects. Additionally, healthcare providers should ensure that patients are aware of any allergies they may have to the ingredients in the product, as this could lead to serious reactions.

Patients must be counseled to discontinue use and consult a doctor if they experience excessive redness or irritation. They should also be advised to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using the product, patients should be reminded to follow the directions carefully and to avoid contact with the eyes, mucous membranes, or rashes to prevent irritation or other complications.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, avoiding direct sunlight to maintain its integrity. Additionally, the product must be protected from excessive moisture to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's effectiveness.

Additional Clinical Information

The medication is administered topically, with a recommended application of one patch at a time to the affected area. Patients should not apply more than three to four patches daily, and each patch should be worn for a maximum of eight hours.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)