Sombra Cool Therapy

Description

No specific details regarding the Description section for SPL code 34089-3 are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with conditions such as simple backaches, 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 physician prior to use.

The gel is intended for topical application exclusively to the affected area. It is essential to adhere to the specified frequency of application to ensure safety and efficacy.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The product is intended for external use only and must not be applied to wounds or damaged skin. Healthcare professionals should advise patients to avoid tightly bandaging the area where the product is applied and to prevent contact with the eyes. It is essential to keep the product out of reach of children to avoid accidental ingestion or misuse.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. These guidelines are crucial for ensuring patient safety and effective management of their condition.

No specific emergency medical help instructions or general precautions have been provided. Additionally, there are no laboratory tests recommended for monitoring the use of this product.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. When using 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.

In the event that the condition worsens, symptoms persist for more than 7 days, or if the condition clears up and then recurs within a few days, patients are advised to stop use and consult a doctor. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Sombra 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. When using this product, caregivers must avoid bandaging tightly and ensure that it does not come into contact with the eyes.

For children aged 2 years and older, the recommended dosage is to apply the product to the affected area no more than 3 to 4 times daily, ensuring thorough rubbing until the gel is fully absorbed. For children under 2 years of age, consultation with a doctor is necessary prior to use.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of Sombra Cool Therapy during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

The safety of this product has not been established in nursing mothers. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to lactating mothers.

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

If available, the use of antidotes or specific treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 available in the insert text.

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 improper access to the medication, ensuring that patients understand the necessity of safeguarding it in a secure location.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

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 apply the gel to the affected area and rub it in thoroughly until fully absorbed. For children under 2 years of age, it is advised to consult a doctor 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 Cool Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)