Elevate Heating Therapy

Description

The product is presented in a 2 oz. cream formulation, contained within a tube designed for heating therapy. This dosage form is intended for topical application. The cream is specifically formulated to provide therapeutic heat to the affected area.

Uses and Indications

This drug is indicated for external use on muscles and joints to alleviate stiffness. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Healthcare professionals should instruct patients to massage the desired amount of the medication into the affected skin area. This application may be performed no more than 10 times daily, or as directed by a physician.

For pediatric patients under 12 years of age, it is essential to consult a physician prior to use to ensure appropriate dosing and administration.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid applying the product to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. It is crucial to instruct patients not to bandage the area tightly when using this product, as this could impede proper healing and increase the risk of irritation.

Care should be taken to prevent contact with the eyes. In the event of accidental contact, patients should be instructed to rinse the eyes thoroughly with water and seek medical attention if irritation persists.

Patients should be monitored for any worsening of their condition. If symptoms do not improve within 7 days, or if they resolve and then recur within a few days, it is recommended that they discontinue use and consult a healthcare professional for further evaluation.

To ensure safety, this product should be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only. It is advised that patients do not bandage the area tightly when using this product and should avoid contact with the eyes. Additionally, the product should not be applied to wounds or damaged skin.

Patients are instructed to discontinue 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. It is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Elevate Heating Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult their physician prior to 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 options 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 adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Use is contraindicated in pregnancy due to potential risks to the fetus. Pregnant women are advised to consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact the Poison Control Center without delay.

Prompt action 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 management strategy.

Healthcare providers should be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management 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 medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with swallowing the medication. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control center immediately. This guidance is crucial for ensuring patient safety and minimizing the risk of adverse effects.

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 in a manner that protects it from direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Elevate Heating Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)