Just Cbd Roll-on Cooling

Description

No description information is available for the drug.

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

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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 no specific data available regarding the excretion of this medication in 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section, nor is there any data available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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)