Sombra Plus Cbd 2000mg Cool Therapy

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including those resulting from strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the gel to the affected area no more than 3 to 4 times daily. The gel should be rubbed in thoroughly until fully absorbed.

For children under 2 years of age, it is advised to consult a healthcare professional before use.

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. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

The product is intended for external use only and should not be applied to wounds or damaged skin. Additionally, it should not be used in conjunction with any heat sources. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use to ensure safety.

When utilizing this product, it is crucial to avoid tightly bandaging the area of application and to prevent contact with the eyes. Furthermore, the product must be kept out of reach of children to prevent accidental ingestion or misuse.

No specific laboratory tests or emergency medical procedures are outlined in the available information. Healthcare professionals should remain vigilant and monitor for any adverse reactions or complications associated with the use of this product. In the event of any concerning symptoms or reactions, it is recommended to discontinue use and consult a healthcare provider for further guidance.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. The use of this product in conjunction with a heat source is contraindicated. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

When utilizing this product, it is important to avoid bandaging tightly and to prevent contact with the eyes. Additionally, the product should be kept out of reach of children to ensure safety.

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 Sombra Plus Cbd 2000mg Cool Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. It is for external use only and should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heat source.

For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily, ensuring thorough rubbing in until the gel is fully absorbed. For children under 2 years of age, consultation with a doctor is necessary prior to use.

Healthcare professionals should also instruct caregivers to avoid bandaging tightly and to prevent contact with the eyes during application.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when making recommendations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 for SOMBRA PLUS CBD 2000MG COOL THERAPY.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability while adhering to safety standards. It is essential to store the product at room temperature to maintain its efficacy.

To ensure safety, the product should be kept out of reach of children and is intended for external use only. It must not be applied to wounds or damaged skin, and care should be taken to avoid contact with the eyes.

Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily. Patients should rub the gel into the affected area thoroughly until it is fully absorbed. For children under 2 years of age, consultation with a doctor is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sombra Plus Cbd 2000mg Cool Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)