Cold and Hot Pain Relief

Description

The Cold and Hot Pain Relief Patch is designed for the temporary relief of minor aches and pains. This topical dosage form provides dual-action therapy through the application of cold and heat. The patch is formulated to adhere securely to the skin, ensuring localized treatment. Its appearance is characterized by a flexible, skin-friendly material that allows for comfortable wear during daily activities.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, muscle strains, simple backache, bursitis, cramps, tendonitis, muscle sprains, and bruises.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage involves the application of one patch to the affected area. The backing of the patch should be removed by grasping both ends firmly and carefully peeling it away. This process may be repeated as necessary, with a maximum frequency of four applications per day.

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

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the following precautions should be observed:

• Tight bandaging is not recommended.

• The application of a heating pad is contraindicated.

• Contact with eyes and mucous membranes should be avoided.

• Application to wounds or damaged skin is prohibited.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging the area tightly and to refrain from using a heating pad in conjunction with this product. Care should be taken to prevent contact with the eyes and mucous membranes, as exposure may lead to irritation. Application to wounds or damaged skin is contraindicated. Individuals with known allergies to any ingredients in this formulation should not use the product.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness appears, or irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product only as directed, avoiding tight bandaging and the use of heating pads. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged skin. Patients with known allergies to any ingredients in this product should refrain from use.

In clinical practice, patients are advised to stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. The presence of redness or the development of irritation also warrants discontinuation and medical consultation.

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 should be made.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, 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 Pain Relief (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. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this age range. Caution is advised when considering treatment for pediatric patients.

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, 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 drug 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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, it is essential to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and improve outcomes.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and implement appropriate measures based on the severity of symptoms and the specific circumstances of the overdosage.

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 in the insert text.

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 their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, if redness is present, or if irritation develops.

When using this product, patients must be reminded to use it only as directed. They should not bandage the area tightly or use a heating pad in conjunction with the product. It is important to avoid contact with the eyes and mucous membranes, and patients should not apply the product to wounds or damaged skin. Additionally, patients should be cautioned against using the product if they are allergic to any of its ingredients.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product is administered topically, with one patch applied to the affected area as needed, not exceeding four applications per day. Clinicians should advise patients that the product is for external use only and must be used strictly as directed. Patients should avoid bandaging tightly, using heating pads, and contact with eyes or mucous membranes. It is contraindicated for application on wounds or damaged skin, and individuals with known allergies to any ingredients should refrain from use.

Patients are instructed to discontinue use and consult a healthcare professional if their condition worsens, symptoms persist beyond seven days, or if redness or irritation occurs. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use. The product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)