Cool and Heat Sore Muscle Roller

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame. When utilizing this product, it is imperative to adhere strictly to the directions provided. Bandaging should not be applied tightly, nor should it be used in conjunction with a heating pad. Care should be taken to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or to skin that is damaged, broken, or irritated.

Users may experience a transient burning sensation upon application, which typically resolves within several days. However, if a severe burning sensation occurs, the use of the product should be discontinued immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

Healthcare professionals should advise patients to stop using the product and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized based on their seriousness and frequency.

Warnings associated with the use of this product include its flammability; therefore, it should be kept away from fire or flame. Patients are advised to use the product only as directed and to avoid bandaging tightly or using it in conjunction with a heating pad. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or damaged, broken, or irritated skin.

A transient burning sensation may occur upon application, which typically resolves within several days. However, if a severe burning sensation occurs, patients should discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

Patients are instructed to stop use 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.

For pregnant or breastfeeding patients, it is recommended to seek advice from a health professional before using this product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Cool and Heat Sore Muscle Roller (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3-4 times daily.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is accidentally ingested, they should seek medical help or contact a Poison Control Center immediately. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame. Additionally, the product must be protected from heat and direct sunlight to maintain its integrity. It is essential to keep the product out of reach of children. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3-4 times daily, while those under 2 years should consult a physician prior to use. Clinicians should counsel patients that the product is for external use only and is flammable; it should be kept away from fire or flame.

When using the product, patients must adhere to the following precautions: apply only as directed, avoid tight bandaging or use with heating pads, and prevent contact with eyes and mucous membranes. It should not be applied to wounds or damaged skin. A transient burning sensation may occur upon application, typically resolving within several days; however, if a severe burning sensation occurs, use should be discontinued immediately. Patients should stop use and consult a doctor if the condition worsens, symptoms persist beyond 7 days, or if symptoms clear and recur within a few days. Pregnant or breastfeeding individuals should seek advice from a health professional before use. The product should be kept out of reach of children, and in case of accidental ingestion, medical help or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Cool and Heat Sore Muscle Roller, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)