Cbd Menthol Pain Relief

Description

This formulation contains 150 mg of cannabidiol (CBD) and menthol, designed as a fast-acting pain relief roller. The product is presented in a dosage form of a topical roller, with a net weight of 3 fluid ounces (88 ml).

Uses and Indications

This drug is indicated for the temporary relief of muscle and joint pain associated with arthritis, as well as for the alleviation of muscle aches, muscle strains, and joint pain.

Limitations of Use: This medication is intended for short-term use and should not be used as a substitute for comprehensive treatment of underlying conditions.

Dosage and Administration

Healthcare professionals are advised to administer the medication strictly as directed. It is contraindicated for use in children under 12 years of age. The medication should be applied by rolling it onto the affected area, with a maximum frequency of four times daily. Prior to each application, it is essential to shake the container well to ensure proper mixing of the formulation.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or irritated skin is prohibited due to the potential for exacerbating the condition. Additionally, tight bandaging or concurrent use with a heating pad is not recommended, as this may lead to adverse effects. If symptoms worsen, pain persists for more than 7 days, or if the condition resolves and then recurs within a few days, discontinue use and consult a healthcare professional.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin or are currently taking any blood thinners. It is imperative that the product is not applied to wounds or irritated skin. Additionally, patients should be instructed not to bandage the area tightly or use it in conjunction with a heating pad. After application, hands should be washed thoroughly with cool water to prevent unintended contact with other areas of the body.

For individuals who are pregnant or breastfeeding, it is recommended to seek guidance from a health professional before using this product. Furthermore, it is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate contact with a doctor or poison control center is necessary.

Patients should be advised to discontinue use and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve only to reoccur within a few days.

Side Effects

Patients using this product should be aware of several important safety considerations. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if pain persists for more than 7 days, or if the condition clears up and then reoccurs within a few days.

Additionally, it is recommended that patients seek medical advice before using the product if they have sensitive skin or are currently taking any blood thinners. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking any anticoagulants or blood thinners. The combination may increase the risk of bleeding or other adverse effects. Monitoring of coagulation parameters may be warranted, and dosage adjustments of the anticoagulant may be necessary based on clinical judgment.

Packaging & NDC

Below are the non-prescription pack sizes of Cbd Menthol Pain Relief (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and the use of this product in children younger than 12 years is contraindicated.

Geriatric Use

There is no specific information available 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and breastfeeding infants are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical attention. If the medication is accidentally swallowed, healthcare professionals should be contacted without delay. This may involve reaching out to a physician or a poison control center for guidance on the appropriate course of action.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement necessary management procedures based on the severity of the situation and the specific symptoms presented.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children and to contact a doctor or poison control center immediately if the product is accidentally swallowed.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if the condition clears up and then reoccurs within a few days.

When using this product, patients must be cautioned against applying it to wounds or irritated skin. They should also be informed not to bandage the area tightly or use it in conjunction with a heating pad.

It is important for patients to wash their hands with cool water after using the product to prevent any unintended exposure.

Additionally, healthcare providers should recommend that patients consult a doctor before using the product if they have sensitive skin or are currently taking any blood thinners.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the cap is tightly closed to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

Patients should apply the product by rolling it onto the affected area no more than four times daily. Clinicians are advised to counsel patients to consult a doctor prior to use if they have sensitive skin or are taking any blood thinners. Additionally, pregnant or breastfeeding patients should seek advice from a health professional before using the product.

Patients are instructed to discontinue use and consult a doctor if their condition worsens, if pain persists for more than 7 days, or if the condition improves and then recurs within a few days.

Drug Information (PDF)

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

View product document (PDF)