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Coldsore Bomb

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This product has been discontinued

Active ingredient
Menthol 1 g/100 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
October 2, 2020
Active ingredient
Menthol 1 g/100 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
October 2, 2020
Manufacturer
Envisionate PSJ LLC
Registration number
part346
NDC root
72883-020

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Drug Overview

Menthol is a compound commonly used for its soothing properties. It is often found in various over-the-counter products, such as topical ointments and cough drops, where it provides a cooling sensation that can help relieve minor aches and pains or soothe throat irritation.

You may encounter menthol in products designed to ease discomfort, as it works by stimulating the skin's cold receptors, which can create a refreshing feeling. This makes it a popular choice for those seeking relief from minor discomforts.

Uses

It seems that there are no specific uses or indications provided for this medication. Additionally, there are no mentions of teratogenic effects (which refer to substances that can cause developmental abnormalities in a fetus) or nonteratogenic effects. If you have any questions or need further information about this medication, please consult your healthcare provider for personalized advice.

Dosage and Administration

If you or your child is 2 years old or older and need to use this medication, you should apply it directly to the affected area. Make sure not to apply it more than 5 times in a single day. This helps ensure that you get the best results while minimizing the risk of side effects. Always follow the recommended application frequency for safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

There are no specific side effects or warnings associated with this medication. It is important to keep it out of reach of children to ensure their safety. If you have any concerns or experience unusual symptoms while using this product, please consult your healthcare provider for guidance.

Warnings and Precautions

You can feel reassured that there are no specific warnings or precautions associated with this medication. It is also important to note that no laboratory tests are required for safe use, which simplifies your experience.

Since there are no instructions for emergency medical help or for stopping the medication and contacting your doctor, you can use this medication without the added concern of these factors. However, always stay attentive to how you feel while taking any medication and consult your healthcare provider if you have any questions or concerns.

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, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

There is no specific information available about the use of COLDSORE BOMB - menthol ointment during pregnancy. This means that the drug insert does not provide guidance on whether it is safe or unsafe for you to use while pregnant. Additionally, there are no warnings about potential risks to your baby or any necessary changes to how you should use the product during this time.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any new products, including topical ointments like COLDSORE BOMB. They can help you make informed decisions based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

Pediatric Use

When using this medication for children aged 2 years and older, you should apply it to the affected area no more than five times a day. It's important to follow this guideline to ensure safety and effectiveness. Always monitor your child for any unusual reactions and consult your healthcare provider if you have any concerns.

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

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health.

Make sure to keep your doctor informed about your liver condition, as they may want to monitor your liver function regularly to ensure everything is working well. Your health and safety are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions reported. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 68 to 77°F (20 to 25ºC). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is the recommended application frequency for menthol?

For adults and children 2 years of age and older, apply menthol to the affected area no more than 5 times daily.

Are there any contraindications for using menthol?

No contraindications are listed for menthol.

Is menthol safe to use during pregnancy?

The insert does not provide specific information regarding the use of menthol during pregnancy.

Can nursing mothers use menthol?

There is no specific information provided regarding the use of menthol by nursing mothers.

What are the storage conditions for menthol?

Store menthol at room temperature between 68 to 77°F (20 to 25ºC).

Packaging Info

Below are the non-prescription pack sizes of Coldsore Bomb (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Coldsore Bomb.
Details

Drug Information (PDF)

This file contains official product information for Coldsore Bomb, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Menthol is a cyclic monoterpene alcohol with the chemical formula C10H20O. It has a molecular weight of 156.27 g/mol. Menthol appears as a colorless to pale yellow crystalline solid at room temperature. It is commonly used in various pharmaceutical formulations for its cooling and soothing properties.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area, not exceeding five times daily. Care should be taken to ensure that the application is evenly distributed over the affected area to maximize therapeutic effect.

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

There are no specific warnings or precautions associated with the use of this product as outlined in the insert. Healthcare professionals should be aware that no general precautions have been provided, and there are no recommended laboratory tests necessary for the safe use of this medication. Additionally, the insert does not include instructions for seeking emergency medical help or directives to discontinue use and consult a physician. It is essential for healthcare providers to remain vigilant and monitor patients as appropriate, despite the absence of explicit warnings or precautions in the product information.

Side Effects

There are no specific side effects or warnings associated with the use of this product. In clinical trials and postmarketing experiences, no adverse reactions have been reported. As a precaution, it is advised to keep this product out of reach of children.

Drug Interactions

There are no reported drug interactions associated with this medication. Additionally, there is no information regarding interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Coldsore Bomb (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Coldsore Bomb.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 5 times daily. There are no specific dosage adjustments indicated for this age group. Care should be taken to ensure that the application does not exceed the recommended frequency.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of COLDSORE BOMB - menthol ointment in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy, nor does it provide any data on potential risks to the fetus. Additionally, there are no recommendations for dosage modifications or special precautions for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the benefits against any potential risks when recommending this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist is recommended for 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 the 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. Patients should be encouraged to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 68 to 77°F (20 to 25ºC). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Coldsore Bomb, 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 Coldsore Bomb, 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.

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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.