ADD CONDITION

items per page

Elevate Cbd Heating Therapy

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 5.6 g/112 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
January 13, 2022
Active ingredient
Menthol 5.6 g/112 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
January 13, 2022
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-455

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Elevate Topical Cream is a specially formulated cream designed to support your well-being by unlocking the body's endocannabinoid system (ECS) receptors. This cream contains menthol and magnesium, which work together to provide relief, particularly for sore muscles and joints.

Pharmaceutically produced and lab tested for purity, quality, and safety, Elevate Topical Cream is intended for external use, helping you feel more comfortable and at ease in your daily activities.

Uses

You can use this product externally on your muscles and joints to help relieve soreness. It's designed to provide targeted relief where you need it most, making it a convenient option for managing discomfort. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, so it can be used safely in that regard.

Dosage and Administration

To use this medication, you should massage the desired amount into the affected area of your skin. You can do this up to 10 times a day, but it's important to follow your doctor's instructions if they provide specific guidance.

If you are considering this treatment for a child under 12 years old, make sure to consult with your doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should stop using it and consult your doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days. While using this product, make sure not to bandage the area tightly, and avoid contact with your eyes. Additionally, do not apply it to wounds or damaged skin, and refrain from using it with heating pads or other heating devices.

By following these guidelines, you can help ensure a safer experience with the product.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to wounds or damaged skin, and do not use it with heating pads or other heating devices. Make sure to keep it away from your eyes and do not bandage the area tightly. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, you should stop using the product and consult your doctor.

Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin, and do not use it with heating pads or other heating devices. When using this product, do not bandage the area tightly, and be careful to keep it away from your eyes. Always keep it out of reach of children.

If your condition worsens, or if your symptoms last more than 7 days or improve and then come back within a few days, stop using the product and consult your doctor. If the product is swallowed, seek medical help immediately or contact a Poison Control Center.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for assistance. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek immediate medical help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

While there are no specific warnings or precautions regarding the use of ELEVATE CBD HEATING THERAPY during pregnancy mentioned in the information provided, it’s important to approach any product with caution. The insert does not indicate whether the product is contraindicated (not recommended) during pregnancy or if there are any potential risks to the fetus.

Since there are no dosage modifications or special precautions outlined for pregnant individuals, it’s always best to consult with your healthcare provider before using any new product during pregnancy. They can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no statements about the product being present in breast milk or any potential risks to your infant. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your baby’s health.

Pediatric Use

If you have a child under 12 years old, it's important to consult your doctor before using this medication. Your healthcare provider can give you the best advice tailored to your child's specific needs and ensure their safety. Always prioritize professional guidance when it comes to treating younger children.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place, away from direct sunlight. Exposure to sunlight can affect its effectiveness, so it's important to keep it protected.

When handling the product, make sure to follow any specific instructions provided to maintain its integrity. Always ensure that your hands and any surfaces are clean to avoid contamination. If you have any questions about disposal or further safety measures, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically, which means you will be putting it directly on your skin. Massage the recommended amount into the affected area, but do not exceed 10 applications in a day unless your doctor advises otherwise. Always follow your healthcare provider's instructions for the best results.

FAQ

What is Elevate Topical Cream used for?

Elevate Topical Cream is for external use on muscles and joints where you feel soreness.

How should I use Elevate Topical Cream?

Massage a desired amount into the affected skin area no more than 10 times daily or as directed by your doctor.

Are there any warnings I should be aware of?

Yes, do not bandage tightly, avoid contact with eyes, and do not apply to wounds or damaged skin. Also, do not use with heating pads or other heating devices.

What should I do if my condition worsens?

Stop use and ask your doctor if your condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is Elevate Topical Cream safe for children?

Consult your doctor before using Elevate Topical Cream on children under 12 years of age.

Can I use Elevate Topical Cream during pregnancy?

There are no specific warnings or precautions regarding the use of Elevate Topical Cream during pregnancy mentioned in the provided information.

What should I do if I accidentally swallow Elevate Topical Cream?

If swallowed, get medical help or contact a Poison Control Center right away.

Are there any known side effects of Elevate Topical Cream?

No specific side effects are mentioned, but you should stop use and consult a doctor if symptoms persist.

Is there any information about drug interactions?

No drug interactions information is found for Elevate Topical Cream.

How should I store Elevate Topical Cream?

Keep Elevate Topical Cream out of direct sunlight and out of reach of children.

Packaging Info

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

Packaging configurations for Elevate Cbd Heating Therapy.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Elevate Topical Cream is a pharmaceutical formulation designed to interact with the body's endocannabinoid system (ECS) receptors, promoting overall well-being. The cream is specifically formulated by medical professionals and contains active ingredients such as menthol and magnesium, which contribute to its efficacy in providing relief. This product undergoes rigorous laboratory testing to ensure its purity, quality, and safety, adhering to high standards of pharmaceutical production.

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 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 should not exceed 10 times daily unless otherwise directed by a physician.

For pediatric patients under 12 years of age, it is essential to consult a healthcare provider prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in the following situations:

  • Discontinue use and consult a healthcare professional if the condition worsens or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

  • Avoid tight bandaging while using this product.

  • Contact with the eyes must be avoided.

  • Application to wounds or damaged skin is contraindicated.

  • The use of heating pads or other heating devices in conjunction with this product is not recommended.

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 this 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.

Users should refrain from using this product in conjunction with heating pads or other heating devices, as this may increase the risk of skin irritation or burns. If the condition worsens, or if 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 healthcare professional.

It is crucial to keep this product out of reach of children. 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 should be aware of several important warnings and precautions. The product is intended for external use only. It is advised that patients do not bandage the area tightly while using the product, and they should avoid contact with the eyes. Application to wounds or damaged skin is contraindicated. Additionally, the product should not be used in conjunction with heating pads or other heating devices.

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 resolve 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, medical assistance should be sought immediately, or contact with a Poison Control Center is recommended.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Elevate Cbd Heating Therapy.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional 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 age range. 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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There are no specific warnings or precautions regarding the use of ELEVATE CBD HEATING THERAPY during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any associated risks to the fetus. Additionally, no dosage modifications or special precautions for individuals who are pregnant are provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk, risks to breastfed infants, or any other lactation-related considerations.

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 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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion or misuse. Patients should be instructed 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.

While using the product, patients must be cautioned against bandaging tightly, as this may lead to complications. It is important to emphasize the need to avoid contact with the eyes, as this could result in irritation or injury. Additionally, patients should be informed not to apply the product to wounds or damaged skin to prevent adverse reactions. Lastly, healthcare providers should advise against the use of heating pads or other heating devices in conjunction with this product, as this may increase the risk of side 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

The product is administered topically, with the recommended application being to massage the desired amount into the affected skin area no more than 10 times daily, or as directed by a healthcare professional. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Elevate Cbd Heating Therapy, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.