Cold and Hot Medicated

Description

The product is a Cold and Hot Medicated Patch designed for topical application. It provides localized relief through the application of heat or cold, depending on the intended use. The patch is formulated to adhere securely to the skin, ensuring effective delivery of its therapeutic properties.

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 are instructed to 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 recommended to consult a physician prior to use.

For optimal application, the healthcare professional should advise patients to partially peel back the protective film of the patch and apply the exposed portion directly to the site of pain. The remaining film should be carefully removed while ensuring that the patch adheres firmly to the skin.

Contraindications

The product should not be applied to wounds, damaged skin, or very sensitive skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly or use in conjunction with a heating pad, as this may increase the risk of skin irritation or other complications.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed to ensure safety and efficacy.

General precautions must be observed to prevent adverse effects. Users should avoid contact with the eyes and mucous membranes. The product should not be applied to wounds, damaged skin, or areas of very sensitive skin. Additionally, it is advised not to bandage the area tightly or use the product in conjunction with a heating pad, as this may exacerbate irritation or cause other complications.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: excessive redness or irritation at the application site, worsening of the condition, persistent pain lasting 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 the individual should contact a Poison Control Center without delay.

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 in conjunction with a heating pad.

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 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.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Cold and Hot Medicated (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 and children aged 12 years and older, the patch may be applied to the affected area as needed, with a maximum frequency of four applications per day.

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 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 drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor 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.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and they should not apply the product to wounds or to damaged or very sensitive skin. Additionally, patients should be cautioned against tightly bandaging the area or using the product in conjunction with a heating pad.

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. Additionally, 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 of age, it is advised to consult a doctor before use.

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

Drug Information (PDF)

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

View product document (PDF)