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Sombra Plus Cbd 1000mg Cool Therapy

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 0.06 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
May 20, 2022
Active ingredient
Menthol 0.06 g/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
May 20, 2022
Manufacturer
Sombra Cosmetics Inc.
Registration number
part348
NDC root
61577-7100

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Drug Overview

Sombra CT Plus is a topical product designed to temporarily relieve minor aches and pains in muscles and joints. It can be particularly helpful for discomfort associated with strains, bruises, and sprains. This means that if you're dealing with soreness from physical activity or minor injuries, Sombra CT Plus may provide you with some relief.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's particularly effective for discomfort caused by strains, bruises, and sprains. Whether you've overexerted yourself during exercise or have a minor injury, this treatment can ease your discomfort and help you get back to your daily activities.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the gel to the affected area of your skin. Make sure to do this no more than 3 to 4 times a day. After applying, rub the gel in thoroughly until it is fully absorbed into your skin.

If your child is under 2 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the best course of action for your child's specific needs.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should only use it externally and avoid applying it to wounds or damaged skin. Additionally, do not use it near a heat source. If you are pregnant or breastfeeding, consult your healthcare professional before using this product.

While using it, make sure to avoid tightly bandaging the area and keep it away from your eyes. Always keep the product out of reach of children to ensure their safety.

Warnings and Precautions

This product is intended for external use only, so please do not apply it to wounds or damaged skin. It's important to avoid using it near heat sources, and if you are pregnant or breastfeeding, make sure to consult a healthcare professional before using it.

While using this product, be cautious not to bandage tightly and avoid contact with your eyes. Always keep it out of reach of children to ensure their safety. If you experience any unusual reactions or have concerns, stop using the product and contact your doctor for further advice.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using this medication. This ensures that you receive personalized advice and understand any potential risks to you or your baby. Always prioritize your health and the health of your child by seeking guidance from a qualified expert.

Lactation Use

If you are pregnant or breastfeeding, it’s important to talk to your healthcare professional before using this medication. They can help you understand any potential risks and ensure that you make the best choice for your health and your baby’s well-being. Always prioritize open communication with your doctor regarding any medications you may consider while nursing.

Pediatric Use

It's important to keep this product out of reach of children to ensure their safety. For children aged 2 years and older, you can apply the gel to the affected area up to 3 to 4 times a day, making sure to rub it in thoroughly until it is fully absorbed. However, if your child is under 2 years old, you should consult a doctor before using this product. Always prioritize your child's safety and follow these guidelines carefully.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the safety and effectiveness of the product, store it at room temperature, away from direct sunlight and moisture. It's important to keep it out of reach of children to prevent accidental ingestion or misuse. Remember, this product is for external use only, so avoid applying it to wounds or damaged skin, and take care to prevent contact with your eyes.

Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. Make sure to rub it in thoroughly until the gel is fully absorbed. If you are using it for a child under 2 years old, it's important to consult a doctor first for guidance.

FAQ

What is Sombra CT Plus used for?

Sombra CT Plus temporarily relieves minor aches and pains of muscles and joints associated with strains, bruises, and sprains.

How should I use Sombra CT Plus?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily and rub in thoroughly until the gel is absorbed. For children under 2 years of age, consult a doctor.

Are there any warnings for using Sombra CT Plus?

Yes, it is for external use only. Do not use on wounds or damaged skin, and avoid contact with eyes. If you are pregnant or breastfeeding, consult a healthcare professional before use.

What should I do if I accidentally get Sombra CT Plus in my eyes?

Avoid contact with eyes. If contact occurs, rinse thoroughly with water and seek medical attention if irritation persists.

How should I store Sombra CT Plus?

Store Sombra CT Plus at room temperature and keep it out of reach of children. Discard after opening.

Is there any information on drug interactions with Sombra CT Plus?

No drug interactions information is available for Sombra CT Plus.

Can I use Sombra CT Plus if I have kidney or liver problems?

There is no specific information regarding dosage adjustments or safety considerations for patients with kidney or liver problems provided in the insert.

Packaging Info

Below are the non-prescription pack sizes of Sombra Plus Cbd 1000mg Cool Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sombra Plus Cbd 1000mg Cool Therapy.
Details

Drug Information (PDF)

This file contains official product information for Sombra Plus Cbd 1000mg Cool Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

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

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 medication is intended for short-term use and should not be used for chronic pain conditions without consulting a healthcare professional.

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

This product is intended for external use only. It is imperative that it not be applied to wounds or damaged skin, nor should it be used in conjunction with any heat sources. Healthcare professionals should be consulted prior to use by individuals who are pregnant or breastfeeding to ensure safety and appropriateness.

While utilizing this product, it is essential to avoid tight bandaging and to prevent contact with the eyes. These precautions are critical to minimize the risk of adverse effects. Additionally, this product should be kept out of reach of children to prevent accidental ingestion or misuse.

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

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.

Packaging & NDC

Below are the non-prescription pack sizes of Sombra Plus Cbd 1000mg Cool Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sombra Plus Cbd 1000mg Cool Therapy.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. 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 in until the gel is fully absorbed. For children under 2 years of age, consultation with a doctor is required 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 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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate 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 provided in the insert for SOMBRA PLUS CBD 1000MG 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 must be kept out of reach of children. It is intended for external use only and should not be applied to wounds or damaged skin. 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 a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. 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 1000mg Cool Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Sombra Plus Cbd 1000mg Cool Therapy, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.