Just Cbd Roll-on Cooling

Description

JUST CBD Roll-On Cooling Gel +1500 is a topical formulation designed for localized application. The product is presented in a roll-on dosage form, facilitating ease of use. It is characterized by its cooling properties, which are intended to provide relief upon application. The effective time for this formulation is noted as May 9, 2024. The observation media associated with this product is labeled as COOLING 1500, and it is represented in an image/jpeg format. The reference value for this product is documented as FD-04269 JUST CBD - ROLL-ON COOLING GEL 1500 VER 2 73647-004-03.jpg.

Uses and Indications

This drug is indicated for the temporary local relief of minor pain in muscles and joints.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults over 21 years of age, a small amount of the product should be applied directly to the affected area. The application should be followed by a gentle massage in a circular motion until the product is fully absorbed. It is recommended to allow the product to set for a few seconds after application. This process may be repeated as necessary, but should not exceed 3 to 4 applications within a 24-hour period.

The product is intended for topical application only.

Contraindications

Application of this product is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin, as this may exacerbate the condition. Additionally, it is contraindicated for use on irritated skin or if excessive irritation develops, due to the potential for further skin damage.

Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury. Tight bandaging is not recommended, as it may lead to complications. The use of heating pads or devices in conjunction with this product is contraindicated, as it may increase the risk of adverse effects.

If the condition worsens, or if symptoms persist for more than 7 days, or clear up and recur within a few days, discontinue use and consult a healthcare professional.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a physician prior to use if there is any redness present over the affected area.

General precautions must be observed to ensure safe application. It is imperative to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Patients should be instructed not to bandage the area tightly and to refrain from using the product in conjunction with heating pads or devices.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and seek medical advice.

Emergency medical assistance should be sought immediately if the product is ingested. Patients should be advised to contact a Poison Control Center or seek medical help without delay.

Side Effects

Patients should be aware that the product is for external use only. It is advised that individuals consult a healthcare professional prior to use if there is any redness present over the affected area.

No additional serious or common adverse reactions have been reported in clinical trials or postmarketing experiences. However, it is essential for patients to monitor their condition and report any unexpected reactions to their healthcare provider.

Drug Interactions

The concomitant use of Cannabidiol (CBD) with other medications or in the presence of any medical conditions may pose potential risks. It is imperative that patients consult a healthcare professional prior to initiating CBD therapy to evaluate the safety and appropriateness of its use in their specific circumstances.

Healthcare providers should be vigilant in assessing the potential for drug interactions and the overall health status of the patient when considering CBD as part of a treatment regimen. Monitoring for adverse effects and therapeutic efficacy is recommended to ensure patient safety.

Packaging & NDC

Below are the non-prescription pack sizes of Just Cbd Roll-on Cooling (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is intended solely for use by healthy adults aged 21 years and older. There is no established safety or efficacy for pediatric patients, including infants, children, and adolescents. Therefore, its use in individuals under 21 years of age is not recommended.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, are not the intended population for this product, which is specifically formulated for healthy adults aged 21 years and older. Therefore, the safety and efficacy of this product in geriatric patients have not been established.

Healthcare providers should exercise caution when considering the use of this product in elderly patients, as the lack of clinical data may necessitate careful monitoring and evaluation of potential risks versus benefits. No dosage adjustments or specific recommendations for geriatric patients are provided, underscoring the importance of individualized assessment in this age group.

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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus or nursing 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any relevant nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to avoid contact with the eyes and mucous membranes to prevent irritation or injury.

Patients should be cautioned against applying the product to wounds or damaged skin, as well as to any areas of irritated skin. If excessive irritation develops, they should discontinue use and consult a healthcare professional. Additionally, patients should be informed not to bandage the area tightly after application, as this may exacerbate any potential side effects.

Healthcare providers should emphasize that the product should not be used in conjunction with heating pads or devices, as this may lead to increased risk of adverse effects. 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.

Storage and Handling

The product is supplied in a tightly closed container to ensure stability and integrity. It should be stored in a dry place at controlled room temperature, specifically between 59°-86° F (15°-30° C). Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Just Cbd Roll-on Cooling, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)