Elevate Heating Therapy Twist up

Description

Elevate is presented in a 2-ounce cream stick dosage form. The product is designed for topical application, providing a convenient and portable option for users. The cream stick format allows for precise application to targeted areas.

Uses and Indications

This drug is indicated for external use on muscles and joints to relieve soreness.

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

Dosage and Administration

Healthcare professionals should instruct patients to massage the desired amount of the medication into the affected skin area. This application should not exceed 10 times daily unless otherwise directed by a physician. It is important to ensure that the medication is applied gently and evenly to maximize absorption and effectiveness.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

The product is intended for external use only. It is imperative that users do not apply a tight bandage when using this product, as this may lead to adverse effects. Care should be taken to avoid contact with the eyes, as exposure may result in irritation or injury. The product must not be applied to wounds or damaged skin, as this could exacerbate the condition or lead to complications. Additionally, the use of heating pads or other heating devices in conjunction with this product is contraindicated, as it may increase the risk of adverse reactions.

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

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring of the condition is essential to ensure appropriate management and to prevent potential complications.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid bandaging tightly when using this product, as well as to prevent contact with the eyes. The product should not be applied to wounds or damaged skin, and it is contraindicated for use with heating pads or other heating devices.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or clear up and then occur again within a few days, patients are advised to stop use and consult a doctor. No specific adverse reactions or side effects have been reported in clinical trials or postmarketing experiences.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Elevate Heating Therapy Twist up (menthol cream). 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. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in efficacy and safety profiles compared to older populations.

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 elderly patients closely for any potential adverse effects or changes in therapeutic response, given the lack of detailed guidance in the prescribing information. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this medication for elderly patients.

Pregnancy

There is no information available regarding the use of ELEVATE HEATING THERAPY TWIST UP menthol cream during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and discuss potential risks with their patients.

Lactation

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

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 the use of 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 available information.

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 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 the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control center immediately.

Additionally, healthcare providers should inform patients to discontinue use and consult a doctor if their condition worsens, or if symptoms persist for more than 7 days. Patients should also be made aware that if their symptoms improve and then recur within a few days, they should seek medical advice.

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.

For optimal storage conditions, it is recommended to keep the product in a cool, dry place, away from sources of heat and moisture. Special handling precautions should be observed to ensure that the product remains within the specified temperature range and is not exposed to adverse environmental conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)