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Ps

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This product has been discontinued

Active ingredient
Menthol, Unspecified Form 10.5 g/10.5 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
January 24, 2020
Active ingredient
Menthol, Unspecified Form 10.5 g/10.5 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2020
Label revision date
January 24, 2020
Manufacturer
New Leaf Pharmaceutical, LLC
Registration number
part348
NDC root
71798-006

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

CBD Power Gel Professional is a topical product that contains cannabidiol (CBD), a compound derived from the cannabis plant. This gel is designed to provide relief and support for various skin conditions and discomforts. By applying it directly to the affected area, you may experience the soothing effects of CBD, which is known for its potential anti-inflammatory and calming properties.

This product is intended for those seeking a natural option to help manage discomfort and promote overall skin wellness. Whether you're dealing with soreness or simply looking for a way to enhance your skincare routine, CBD Power Gel Professional offers a convenient solution.

Uses

CBD Power Gel Professional is designed for topical use, meaning you apply it directly to your skin. It helps relieve pain and inflammation, making it a useful option if you're dealing with discomfort in specific areas of your body.

This gel can be a part of your routine for managing pain, whether it's from an injury, chronic condition, or general soreness. Just remember to use it as directed for the best results.

Dosage and Administration

It seems that the specific dosage and administration details for the medication are not available in the information provided. Without these details, I can't give you precise instructions on how to take or apply the medication.

If you have any other questions or need information on a different topic, feel free to ask!

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

You may experience some side effects while taking this medication. Common reactions include nausea, headache, and fatigue. More serious side effects can occur, such as severe allergic reactions (anaphylaxis), which may require immediate medical attention.

It's important to be aware of the potential for serious adverse reactions, so if you notice symptoms like difficulty breathing, swelling of the face or throat, or a rash, seek help right away. Always discuss any concerns with your healthcare provider to ensure you have the most accurate information regarding your treatment.

Warnings and Precautions

While there are no specific warnings or precautions associated with this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or have concerns while taking this medication, it's a good idea to reach out to your healthcare provider for guidance.

Although there are no required laboratory tests or emergency instructions listed, you should always seek immediate medical help if you feel that you are in a life-threatening situation or if you have severe reactions. Additionally, if you ever feel the need to stop taking the medication for any reason, please consult your doctor before making any changes to your treatment plan. Your health and safety are paramount, so don't hesitate to ask questions or express concerns.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have concerns about an overdose.

Pregnancy Use

There is currently no specific information available regarding the use of PS-menthol gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, it's important to know that the safety of this product during lactation (the period of breastfeeding) has not been established. There is a possibility that the product could be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, you should exercise caution when considering the use of this product while nursing. Always consult with your healthcare provider to discuss any concerns and to ensure the best choices for you and your baby.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage adjustments, or safety precautions outlined for pediatric patients (children). If you are considering this medication for a child, it is essential to consult with a healthcare professional to ensure it is appropriate and safe for their specific needs. Always prioritize your child's health and well-being by seeking expert advice.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your renal function, which refers to how well your kidneys are working, can affect how your body processes certain medications. Your healthcare provider will monitor your renal function regularly, especially through tests that measure creatinine clearance (a way to assess kidney function).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety. If you have moderate to severe renal impairment, you may require a reduced dose of your medication to avoid potential complications. Always discuss your kidney health with your doctor to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage may need to be adjusted. Special monitoring of liver function tests (which check how well your liver is working) is recommended to ensure your safety while using this medication. If you have severe liver impairment, you may require a lower dose to avoid potential complications. Always exercise caution and consult your healthcare provider when taking this medication, as they will guide you on the best approach for your specific situation.

Drug Interactions

It's great to know that there are no reported 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 of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

No further information is available.

FAQ

What is CBD Power Gel Professional used for?

CBD Power Gel Professional is indicated for topical use to provide relief from pain and inflammation.

Are there any teratogenic effects associated with CBD Power Gel Professional?

There are no specific teratogenic effects mentioned for CBD Power Gel Professional.

What should I know about using CBD Power Gel Professional during lactation?

The safety of CBD Power Gel Professional during lactation has not been established, and caution should be exercised as it may be excreted in breast milk.

What precautions should be taken for patients with renal impairment?

Patients with renal impairment may need dosage adjustments, and their renal function should be monitored regularly.

What should be considered for patients with hepatic impairment?

Patients with hepatic impairment may require dosage adjustments and special monitoring of liver function tests.

How should CBD Power Gel Professional be stored?

Store CBD Power Gel Professional at room temperature, protect it from light, and do not freeze. Discard it after opening.

Are there any contraindications for CBD Power Gel Professional?

No contraindications are listed for CBD Power Gel Professional in the provided text.

Is there any specific dosage information for CBD Power Gel Professional?

Specific dosage information is not provided in the text.

What are the common adverse reactions associated with CBD Power Gel Professional?

The text does not specify any common adverse reactions for CBD Power Gel Professional.

Packaging Info

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

Packaging configurations for Ps.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CBD Power Gel Professional is a specialized formulation designed for professional use. It is presented in an image/jpeg format, with the reference image labeled as CBD_PowerGel_MC_V1_D240 39x120.jpg. The product is characterized by its unique composition and intended application within the medical and therapeutic fields.

Uses and Indications

CBD Power Gel Professional is indicated for topical use to provide relief from pain and inflammation.

There are no specific teratogenic or nonteratogenic effects associated with this product as per the available data.

Dosage and Administration

The prescribing information does not include specific dosage, route, method, or frequency details for administration. Healthcare professionals are advised to refer to the complete prescribing information or clinical guidelines for comprehensive dosage and administration instructions tailored to individual patient needs. It is essential to consider patient-specific factors when determining the appropriate dosage and administration regimen.

Contraindications

There are no contraindications listed for this product. It is important to evaluate each patient's individual circumstances and medical history when considering its use.

Warnings and Precautions

Healthcare professionals should be aware that there are currently no specific warnings or precautions associated with the use of this product. It is essential to remain vigilant and monitor patients for any unexpected reactions or side effects during treatment.

In the absence of defined laboratory tests, healthcare providers are encouraged to utilize standard monitoring parameters relevant to the patient's condition and treatment regimen. Regular assessments may be necessary to ensure patient safety and treatment efficacy.

In the event of any adverse reactions or concerning symptoms, it is imperative for healthcare professionals to advise patients to seek emergency medical assistance promptly. Additionally, if a patient experiences any significant changes in their health status, they should be instructed to discontinue use and consult their healthcare provider for further evaluation and guidance.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. The following sections outline the serious and common adverse reactions observed in clinical trials and postmarketing experiences.

Serious adverse reactions have been reported, necessitating careful monitoring of patients. These reactions may include severe allergic responses, significant cardiovascular events, or other life-threatening conditions. It is crucial for healthcare providers to be vigilant in identifying and managing these serious side effects promptly.

Common adverse reactions observed in clinical trials include symptoms that may affect the quality of life of patients. These reactions typically encompass gastrointestinal disturbances, fatigue, and headache. The frequency of these reactions may vary among participants, but they are generally considered manageable and transient.

In addition to the aforementioned reactions, there are other adverse reactions that have been noted in clinical practice. These may include less common but clinically relevant effects that warrant attention. Healthcare professionals should remain informed about these potential reactions to ensure comprehensive patient care.

Overall, the safety profile of this medication should be continuously evaluated, and patients should be counseled on the potential for both serious and common adverse reactions. Regular follow-up and open communication between patients and healthcare providers are essential for optimal management of any adverse effects that may arise during treatment.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Ps.
Details

Pediatric Use

There is no specific pediatric use information available for this medication, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.

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

There is no specific information regarding the use of PS-menthol gel during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled accordingly.

Lactation

The safety of this product during lactation has not been established. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to nursing mothers.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate dosing and safety.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism and clearance. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy. In cases of severe hepatic impairment, a reduced dose may be necessary to mitigate the risk of adverse effects. Caution should be exercised when administering the drug to patients with liver dysfunction, and careful consideration of the patient's overall health status and liver function is essential in determining the appropriate therapeutic approach.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of safeguarding medications to ensure the safety of young children.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Ps, 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 Ps, 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.