Cool and Heat Sore Muscle Roller

Description

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

Uses and Indications

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

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 applying a generous amount of the medication to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed 3 to 4 applications within a 24-hour period. In the event that the medication comes into contact with the hands, it is advised to wash the hands thoroughly with soap and water.

For children aged 12 years or younger, it is recommended to consult a physician prior to use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against tightly bandaging the treated area or using it in conjunction with a heating pad. It is imperative to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or any damaged, broken, or irritated skin. Patients may experience a transient burning sensation upon application; however, this typically resolves within several days. Should a severe burning sensation occur, patients are instructed to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

Patients should be instructed to stop using the product and contact their healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days.

In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted 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 indicate that the product is for external use only. Patients should adhere strictly to the directions provided, avoiding tight bandaging or the use of heating pads in conjunction with the product. Contact with eyes and mucous membranes should be avoided, and the product should not be applied to wounds or areas of damaged, broken, or irritated skin.

A common reaction noted among participants is a transient burning sensation upon application, which typically resolves within several days. However, if a severe burning sensation occurs, patients are advised to discontinue use immediately.

Patients should also be vigilant for signs that warrant discontinuation of the product. They should stop use and consult a healthcare professional if the condition worsens, if redness or irritation develops, or if symptoms persist for more than 7 days or recur shortly after resolution.

Additionally, the product is flammable, and patients are cautioned to keep it away from fire or flame. Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring 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 12 years of age or younger should consult a healthcare professional before 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 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

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 maternal health. 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

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the potential risks and benefits.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from fire or flame to maintain safety. Additionally, the product must be protected from light to preserve its integrity. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The product is intended for topical administration. Adults and children over 12 years should apply it generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of 3 to 4 times daily. For children under 12 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients that the product is for external use only. Patients must follow the directions carefully, avoiding tight bandaging or the use of heating pads, and should 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 be advised to stop use and consult a doctor if the condition worsens, redness or irritation develops, symptoms persist beyond 7 days, or if symptoms recur after clearing. Pregnant or breastfeeding individuals should seek professional advice before use, and the product should be kept out of reach of children. In case of ingestion, medical assistance 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)