Cold/Hot Medicated Patches

Description

The product is identified by the National Drug Code (NDC) 67777-145-10.

Uses and Indications

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

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and over, the affected area should be cleaned and dried prior to application. One patch should be removed from its film and applied directly to the skin over the affected area. A maximum of 1 patch may be applied at a time, with a frequency of no more than 3 to 4 applications per day. Each patch should be worn for a maximum duration of 8 hours.

For children under 12 years of age, it is recommended 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 not recommended, 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 avoid its use to prevent 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 ingredients in this product 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 to prevent adverse reactions.

Healthcare professionals should advise patients to discontinue use and seek medical advice if excessive redness or irritation occurs, if the condition worsens, if symptoms persist beyond 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 contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad. Patients with known allergies to any ingredients in this product should refrain from use.

While using this product, it is crucial to follow the directions provided and to avoid contact with the eyes, mucous membranes, or rashes. If patients experience excessive redness or irritation, or if their condition worsens, they should discontinue use and consult a healthcare professional. Furthermore, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients are advised to seek medical advice.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this product. It is also essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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.

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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. 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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Patients should be made aware of the potential for allergic reactions and should refrain from using the product if they are allergic to any of its ingredients.

Patients should be instructed to discontinue use and consult a doctor if they experience excessive redness or irritation. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 7 days. If symptoms initially improve but then recur within a few days, patients should also be encouraged to consult a healthcare professional.

While using the product, patients must be reminded to follow the directions carefully, avoiding contact with the eyes, mucous membranes, or any rashes to prevent adverse effects.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from 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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)