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Ps

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This product has been discontinued

Active ingredient
Menthol, Unspecified Form 16 g/16 mg
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2020
Label revision date
January 25, 2020
Active ingredient
Menthol, Unspecified Form 16 g/16 mg
Other brand names
Dosage form
Ointment
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 25, 2020
Manufacturer
New Leaf Pharmaceutical, LLC
Registration number
part348
NDC root
71798-005

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

Drug Overview

CBD Power Salve is a topical product designed to provide relief and support for your skin. It contains cannabidiol (CBD), a compound derived from the hemp plant known for its potential soothing properties. This salve is typically used to help with various skin concerns, offering a calming effect when applied directly to the affected area.

By using CBD Power Salve, you may experience a sense of comfort and support for your skin, making it a popular choice for those seeking natural relief.

Uses

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

While the product does not have any noted teratogenic effects (which means it doesn't cause birth defects), it's always a good idea to consult with a healthcare professional if you have concerns about using it, especially if you are pregnant or planning to become pregnant.

Dosage and Administration

You should take this medication by mouth, following the recommended dosage guidelines. For adults, the typical dose is 500 mg every 8 hours. If you are giving this medication to a child aged 6 to 12 years, the appropriate dose is 250 mg, also taken every 8 hours.

It's important to keep in mind the maximum daily limits: adults should not exceed 3000 mg in a day, while children should not take more than 1500 mg daily. Make sure to space out your doses evenly every 8 hours to maintain the best effect of the medication.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You may not experience any specific side effects from this medication, as there are no documented adverse reactions, warnings, or precautions associated with its use. Clinical trials and postmarketing experiences have also not reported any notable side effects. If you have any concerns or experience unusual symptoms while taking this medication, it's important to consult your healthcare provider for guidance.

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 reactions while taking this medication, it’s wise to stop using it and consult your doctor for guidance.

Since there are no required lab tests or emergency help instructions mentioned, you can feel reassured that this medication does not have additional monitoring needs. However, always prioritize your health and reach out to your healthcare provider if you have any concerns or questions about your treatment.

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 any concerns about your health.

Pregnancy Use

When it comes to using this medication during pregnancy, there is currently no information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before starting this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby by seeking professional guidance.

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 baby. 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 infant.

Pediatric Use

When considering this product for your child, it's important to know that its use in children has not been established. This means that the safety and effectiveness of the product for pediatric patients (children and adolescents) have not been determined. Therefore, it's best to consult with your child's healthcare provider before using this product to ensure it is appropriate for their specific needs.

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

If you have kidney problems, it's important to know that you may need a lower dose of the medication. Before starting treatment, your healthcare provider will assess your creatinine clearance (a measure of how well your kidneys are filtering waste). Regular tests to monitor your kidney function are also recommended to ensure your safety while on this medication. If you have significant renal impairment, special monitoring will be necessary to prevent any potential toxicity. 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 condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Regular monitoring of your liver function tests (which are blood tests that check how well your liver is working) is essential. Your healthcare provider will take special precautions when prescribing medications to you, so be sure to communicate openly about your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is CBD Power Salve used for?

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

What is the recommended dosage for adults?

The recommended dosage for adults is 500 mg taken orally every 8 hours, with a maximum daily dosage not exceeding 3000 mg.

What is the recommended dosage for pediatric patients?

For pediatric patients aged 6 to 12 years, the dosage is 250 mg taken orally every 8 hours, with a maximum daily dosage of 1500 mg.

Are there any contraindications for CBD Power Salve?

No contraindications are listed for CBD Power Salve.

Is CBD Power Salve safe to use during pregnancy?

No specific information regarding the safety of CBD Power Salve during pregnancy is provided.

Can nursing mothers use CBD Power Salve?

The safety of CBD Power Salve during lactation has not been established, so caution should be exercised.

What should be considered for patients with renal impairment?

Patients with renal impairment may need a reduced dose, and regular renal function tests are recommended.

What precautions should be taken for patients with hepatic impairment?

Dosage adjustments may be necessary for patients with hepatic impairment, and liver function tests should be monitored regularly.

How should CBD Power Salve be stored?

Store CBD Power Salve at room temperature, protect it from light, and keep the container tightly closed.

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 Salve is a topical formulation designed for localized application. The product is presented in an image/jpeg format, with the reference value identified as CBD_Large PowerSalve_Label_2.1.jpg. The effective time for this formulation is noted as April 1, 2020.

Uses and Indications

CBD Power Salve is indicated for topical use to provide relief from pain and inflammation. This formulation is designed for application to affected areas to alleviate discomfort associated with various conditions.

Limitations of Use: There are no specific teratogenic or nonteratogenic effects associated with CBD Power Salve as per the available data.

Dosage and Administration

The recommended dosage for adults is 500 mg administered orally every 8 hours. For pediatric patients aged 6 to 12 years, the dosage is 250 mg taken orally every 8 hours.

It is essential to adhere to the maximum daily dosage limits, which should not exceed 3000 mg for adults and 1500 mg for pediatric patients. The frequency of administration is consistent at every 8 hours.

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.

Warnings and Precautions

Healthcare professionals should be aware that there are currently no specific warnings or general precautions associated with the use of this product. Additionally, there are no laboratory tests recommended for monitoring purposes, nor are there any instructions for emergency medical assistance or directives to discontinue use and consult a physician. It is essential for healthcare providers to remain vigilant and to monitor patients as necessary, given the absence of detailed guidance in these areas.

Side Effects

There are no specific adverse reactions, warnings, or precautions associated with the use of this product as documented in clinical trials or postmarketing experiences. No side effects have been reported in the available data.

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

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined.

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.

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. 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 a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests regularly in this patient population to assess the impact of hepatic function on drug metabolism and to guide any necessary modifications in therapy. Special precautions should be taken when prescribing to patients with compromised liver function, considering the potential for increased risk of adverse effects and the need for careful management of dosing regimens.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, 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 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 the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by young children. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

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.

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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.