Sombra Plus Cbd 500mg Cool Therapy

Description

The product is identified as Sombra Plus CBD 500mg Cool Therapy, with an SPL Code of 34089-3. It is packaged with a visual representation in the form of an image/jpeg.

Uses and Indications

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

Limitations of Use: This product is intended for the management of minor musculoskeletal discomfort and is not a substitute for professional medical evaluation or treatment of more serious conditions.

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 listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heat source. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use to ensure safety.

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

General precautions emphasize the importance of keeping the product away from children at all times to ensure their safety.

Side Effects

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

While using this product, patients should take precautions to avoid bandaging tightly and to prevent contact with the eyes. Additionally, it is important to keep the product out of reach of children to ensure safety.

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 Sombra Plus Cbd 500mg 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 intended 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 emphasize the importance of avoiding tight bandaging and contact with the eyes during application.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

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

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 and consider 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and follow-up care.

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 500MG COOL THERAPY.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from extreme temperatures, particularly freezing conditions, as freezing may compromise the integrity of the product.

Additionally, the product must be kept out of reach of children to prevent accidental ingestion. Once opened, the product should be discarded to maintain safety and efficacy. Proper handling and storage are crucial to ensure the product remains effective and safe for use.

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 500mg Cool Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)