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Comfortox Lidocaine

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
November 3, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
November 3, 2023
Manufacturer
Sambria Pharmaceuticals
Registration number
M017
NDC root
54723-998
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from pain and itching caused by minor skin irritations. Whether you're dealing with a small cut, scrape, or other minor skin issues, this product can help soothe discomfort and promote a sense of relief. It's important to use it as directed to ensure the best results for your skin.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor skin irritations. It’s designed to help soothe discomfort and make your skin feel better.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it’s considered safe in that regard.

Dosage and Administration

You can use this medication for treating affected areas on your skin if you are an adult or a child aged two years or older. Simply apply it to the area that needs treatment, but make sure not to do this more than three or four times a day. If your child is under two years old, it's important to consult a physician (doctor) before using the medication.

When applying the medication, use a circular motion for about 50 to 60 seconds. This helps ensure that the medication is evenly distributed and absorbed into the skin for the best results.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, always follow your healthcare provider's guidance to ensure safe and effective use. If you have any questions or concerns, don't hesitate to reach out to your healthcare professional for more information.

Side Effects

When using this product, it's important to remember that it is for external use only and should not come into contact with your eyes. Avoid applying it in large amounts, especially on raw or blistered skin.

If your condition worsens, or if symptoms last longer than 7 days or return shortly after improvement, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it in large amounts, especially on raw or blistered skin. Keep it out of reach of children, and if someone accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. It's important to take these precautions seriously to ensure your safety and well-being.

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, if you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is generally not recommended for use in pregnant women due to potential risks to the fetus. Before considering this medication, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

If your healthcare provider does suggest using this medication, be aware that dosage adjustments may be needed. Always prioritize open communication with your provider to ensure that the potential benefits outweigh any risks to your fetus. Use this medication only if it is clearly needed and justified.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Comfortox Lidocaine for nursing mothers. Additionally, there is no information available about whether this medication is passed into breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged two years and older, you can apply it to the affected area no more than three or four times a day. However, if your child is under two years old, it's important to consult a physician (doctor) before using the medication. This ensures that you get the best advice for your child's specific needs. Always follow these guidelines to help keep your child safe and healthy.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even in the absence of specific guidelines, your healthcare team can provide valuable insights and monitor for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your doctor about your health and any concerns you may have.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place. Protect it from excessive heat and direct sunlight, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help ensure that your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching due to minor skin irritation.

Who can use this drug?

It is intended for adults and children two years or older. For children under 2 years, consult a physician.

How should I apply this drug?

Apply to the affected area in a circular motion for 50 to 60 seconds, not more than 3 or 4 times daily.

Are there any contraindications for this drug?

There are no specific contraindications mentioned, but it is not recommended for use in pregnant women due to potential risks.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or recur within a few days.

What precautions should I take when using this drug?

For external use only, avoid contact with eyes, and do not use in large quantities, especially over raw surfaces or blistered areas.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and there may be risks to the fetus; consult a healthcare provider before use.

What should I do if I swallow this drug?

If the product is swallowed, get medical help or contact a Poison Control Center right away.

Are there any known drug interactions?

No specific drug interactions are mentioned for this drug.

How should I store this drug?

Protect this product from excessive heat and direct sunlight.

Packaging Info

Below are the non-prescription pack sizes of Comfortox Lidocaine (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Comfortox Lidocaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by the SPL code 34089-3 and is packaged in a packet format. The media type of the packet is image/jpeg.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritation.

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

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

When applying the product, it should be administered in a circular motion for a duration of 50 to 60 seconds to ensure proper absorption and effectiveness.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects in these conditions. No other contraindications have been specified in the provided data.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be applied in large quantities, especially over raw surfaces or blistered areas, to prevent potential adverse effects.

General precautions must be observed to ensure safety. The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is essential to monitor the patient's response to treatment and adjust the management plan accordingly.

Side Effects

Patients should be aware that the product is intended for external use only and must be kept away from the eyes to prevent irritation. It is important to avoid using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. These precautions are essential to ensure the safety and well-being of patients using this product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Comfortox Lidocaine (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Comfortox Lidocaine.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under the age of 2 years, it is advised to consult a physician 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

Safety during pregnancy has not been established for this medication. It is not recommended for use in pregnant women due to potential risks to the fetus. There may be risks associated with fetal outcomes; therefore, it is essential for healthcare providers to be consulted prior to use.

Dosage adjustments may be necessary for pregnant patients, and medical advice should be sought to determine the appropriate use during pregnancy. Special precautions should be taken, and the medication should only be used if clearly needed, with a careful consideration of whether the potential benefits justify the potential risks to the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of Comfortox Lidocaine in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include airway management, monitoring of vital signs, and intravenous fluid administration as necessary. The use of specific antidotes or treatments should be guided by the clinical scenario and the substances involved.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for further guidance on the management of overdose cases. Documentation of the incident and any interventions performed is crucial for ongoing patient care and safety.

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

Reports of adverse reactions associated with the use of lidocaine hydrochloride cream have been received through voluntary reporting and surveillance programs. These reactions include allergic reactions, skin irritation, erythema, rash, pruritus, and a burning sensation at the application site. Additionally, systemic effects such as seizures and cardiac arrest have been documented in cases of overdose or misuse.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center for assistance. This information is essential for ensuring patient safety and promoting appropriate responses in case of accidental exposure.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity.

Storage conditions should ensure that the product is kept in a cool, dry place, away from sources of heat and light. Special handling precautions should be taken to avoid exposure to extreme temperatures, which may compromise the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Comfortox Lidocaine, 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 Comfortox Lidocaine, 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.