Soundbody 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 administration involves the following steps:

First, the healthcare professional should instruct the patient to remove the backing from the patch by grasping both ends firmly and gently pulling until the backing separates in the middle. Once the backing is removed, the patch should be carefully applied to the affected area. The patch may be reapplied as necessary, but it is important to limit the application to no more than four times daily.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

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: do not bandage tightly, do not use a heating pad, and avoid contact with eyes and mucous membranes. This product should not be applied to wounds or damaged skin.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients against bandaging the area tightly or using a heating pad in conjunction with this product, as these practices may lead to adverse effects.

It is imperative to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds or damaged skin. Patients should be cautioned not to use this product if they have a known allergy to any of its ingredients.

In the event that the patient's condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is essential to discontinue use and consult a physician. Additionally, if redness or irritation develops, medical advice should be sought promptly.

This product should be stored out of reach of children. In cases of accidental ingestion, immediate medical assistance should be obtained, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it 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 the product should refrain from use.

In clinical practice, patients are advised to stop using the product and consult a doctor 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.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no known drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Soundbody 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 category. Caution is advised when considering treatment for pediatric patients.

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 potential 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. 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 prescribing information 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 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. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from 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 use of the compound in these contexts.

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 noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

Patients should be advised that the product is for external use only and must be applied topically. For adults and children over 12 years, one patch should be applied to the affected area, with a maximum of four applications per day as needed. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to follow the directions carefully, avoiding tight bandaging, heating pads, and contact with eyes or mucous membranes. The product should not be applied to wounds or damaged skin, and individuals should refrain from use if they are allergic to any of its ingredients. Patients are instructed to discontinue use and consult a doctor if their condition worsens, symptoms persist beyond seven days, or if irritation or redness occurs. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before use. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

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

View product document (PDF)