Cbd Pain Relief

Description

This roll-on formulation contains 150 mg of cannabidiol (CBD) in a clinical strength menthol formula, designed for pain relief. The product is presented in a 3 fluid ounce (88 mL) container. It is distributed by HOTWORX® 24 Hour Infrared Fitness Studio and is associated with planet beach® spray & spa.

Uses and Indications

This drug is indicated for the temporary relief of foot, ankle, and leg pain associated with arthritis. It is also effective in alleviating muscle aches, muscle strains, muscle sprains, 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.

For application, the medication should be rolled onto the affected area, with a maximum frequency of four times daily. Prior to each use, it is essential to shake the container well to ensure proper mixing of the formulation.

Contraindications

Use is contraindicated in patients with wounds or irritated skin due to the potential for exacerbating the condition.

Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought by contacting a doctor or poison control center.

Discontinue use and consult a healthcare professional if the condition worsens, if pain persists for more than 7 days, or if symptoms resolve and then recur within a few days. It is also contraindicated to apply a tight bandage or use in conjunction with a heating pad.

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 anticoagulant medications.

When utilizing this product, it is imperative to adhere to the following precautions: the product should not be applied to wounds or irritated skin. Additionally, patients should avoid tightly bandaging the area of application or using a heating pad concurrently. It is recommended that individuals wash their hands thoroughly with cool water after application to prevent unintended contact with sensitive areas.

Pregnant or breastfeeding individuals should seek guidance from a healthcare professional before using this product to ensure safety for both mother and child.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical attention should be sought by contacting a doctor or poison control center.

Patients should discontinue use and consult a healthcare provider if their condition worsens, if pain persists for more than 7 days, or if symptoms resolve only to reoccur within a few days. Monitoring for these signs is essential to ensure appropriate management and care.

Side Effects

Patients should be aware that the product is for external use only and is flammable; 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.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking any anticoagulants. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions. Monitoring for signs of increased bleeding or bruising is advised, and dosage adjustments may be necessary based on clinical judgment.

Packaging & NDC

Below are the non-prescription pack sizes of Cbd 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 be administered this medication. Safety and efficacy have not been established in this population, and use in younger children is contraindicated. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients should be carefully considered when prescribing this medication. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should exercise caution when administering this medication to geriatric patients, as age-related physiological changes may affect drug metabolism and response. Monitoring for efficacy and safety is recommended, particularly in this population, to ensure appropriate therapeutic outcomes and to mitigate potential adverse effects.

Dosage adjustments may be necessary based on individual patient factors, including renal and hepatic function, which can be more variable in elderly patients. Regular assessment and adjustment of the treatment regimen may be warranted to optimize safety and effectiveness in this demographic.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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

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 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 prescribing information.

Overdosage

In the event of an overdosage, it is crucial to keep the product out of reach of children. Accidental ingestion may occur, and in such cases, immediate action is required. Healthcare professionals should advise caregivers to contact a physician or a poison control center without delay to ensure appropriate management and intervention.

Prompt medical attention is essential to mitigate potential risks associated with overdosage. The specific symptoms of overdosage may vary depending on the substance involved; therefore, a thorough assessment by a healthcare professional is recommended to determine the appropriate course of action.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 the product 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

The product is administered topically, with a recommended application of no more than four times daily to the affected area. Clinicians should advise patients to consult a doctor prior to use if they have sensitive skin or are taking blood thinners. Additionally, pregnant or breastfeeding patients should seek professional guidance before use. Patients are instructed to discontinue use and consult a doctor if their condition worsens, if pain persists for more than seven days, or if symptoms improve and then reoccur within a few days.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)