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Comfortcaine

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2004
Label revision date
November 11, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 2004
Label revision date
November 11, 2025
Manufacturer
QS Key West Aloe, LLC
Registration number
M017
NDC root
65008-005
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

If you're looking for relief from minor skin discomforts, this medication can help. It is designed to provide temporary relief from pain associated with minor burns, sunburn, scrapes, and other minor skin irritations.

Using this medication can make your experience more comfortable as it targets the pain caused by these common skin issues. Always consult with a healthcare professional for guidance on how to use it effectively.

Uses

If you're dealing with minor burns, sunburn, scrapes, or other minor skin irritations, this product can help provide temporary relief from the pain associated with these conditions. It's designed to soothe your skin and make you feel more comfortable as you heal.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product. You can use it with confidence for your minor skin issues.

Dosage and Administration

If you are an adult or a child aged 2 years or older, you can apply the medication to the affected area up to 3 or 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a physician (doctor) before using the medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding the use of any medication.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence, you should take caution.

If you accidentally ingest this medication, please contact a physician or the Poison Control Center right away for assistance. Your safety is the top priority, so don't hesitate to seek help if needed.

Side Effects

When using this product, it's important to be aware of potential side effects. You should only apply it externally and avoid getting it in your eyes. It's crucial not to use large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last more than a week or return shortly after improvement, stop using the product and consult your doctor.

Always prioritize your safety and well-being while using this product. If you experience any unusual reactions, seek medical advice promptly.

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. If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, stop using the product and consult your doctor.

If you accidentally swallow this product, seek emergency medical help right away by contacting a physician or Poison Control Center. Your safety is important, so please take these precautions seriously.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it’s better to err on the side of caution and get help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of using this medication during pregnancy has not been established. In fact, it is contraindicated, meaning it should not be used while pregnant due to potential risks to your developing baby. There may be specific risks associated with the use of lidocaine during pregnancy, so it’s crucial to consult your physician before considering its use.

Additionally, if you are prescribed this medication while pregnant, your healthcare provider may need to adjust the dosage to ensure safety. Always seek guidance from your healthcare provider to discuss any concerns and to receive personalized advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Comfortcaine while nursing. Currently, there is no information available about whether this medication is passed into breast milk or if it poses any risk to your infant.

As always, it's a good idea to discuss any medications you are considering with your healthcare provider to ensure they are safe for you and your baby.

Pediatric Use

If your child is 2 years old or older, you can apply the medication to the affected area up to 3 or 4 times a day. However, if your child is under 2 years of age, it’s important to consult a physician (doctor) before using this medication. Always follow these guidelines to ensure your child's safety and well-being.

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 wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your healthcare team are essential to ensure safety and effectiveness.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature, ideally between 15-30°C (59-86°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment and dispose of any components according to local regulations to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug provides temporary relief of pain associated with minor burns, sunburn, scrapes, or minor skin irritations.

How should I use the drug?

For adults and children 2 years of age or older, apply to the affected area not more than 3 or 4 times daily. For children under 2 years of age, consult a physician.

Are there any contraindications for using this drug?

There are no listed contraindications, but it should not be used in large quantities, particularly over raw surfaces or blistered areas.

What should I do if I accidentally ingest the drug?

If accidentally ingested, contact a physician or Poison Control Center immediately.

What should I do if my condition worsens or symptoms persist?

If your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Is it safe to use this drug during pregnancy?

Safety during pregnancy has not been established, and there may be risks associated with its use; consult a physician before use.

Can I use this drug while breastfeeding?

There are no specific warnings or recommendations regarding the use of this drug in nursing mothers.

What are the storage conditions for this drug?

Store the drug at room temperature between 15-30°C (59-86°F).

Packaging Info

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

Packaging configurations for Comfortcaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns, sunburn, scrapes, or minor skin irritations.

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 application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

There are no specific contraindications listed for this product. However, in the event of accidental ingestion, it is imperative to contact a physician or the Poison Control Center immediately for further guidance.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. It is imperative that the product not be applied in large quantities, especially on raw surfaces or blistered areas, as this may exacerbate adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought by contacting a physician or the Poison Control Center.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

Patients using this product may experience various side effects. It is important to note that this product is for external use only and should not come into contact with the eyes.

In terms of safety warnings, patients are advised not to use this product in large quantities, especially over raw surfaces or blistered areas. If 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 should discontinue use and consult a healthcare professional.

These precautions are essential to ensure the safe and effective use of the product.

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 Comfortcaine (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Comfortcaine.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, 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 potential 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. Use is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for healthcare providers to consult with a physician before use.

Dosage adjustments may be necessary for pregnant individuals, and it is recommended that healthcare providers offer guidance on appropriate dosing in this population.

Lactation

There are no specific warnings or recommendations regarding the use of Comfortcaine 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential risks associated with excessive administration of the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient's clinical status and initiate appropriate monitoring. Symptoms of overdosage may vary depending on the medication involved and the individual patient's response.

Management procedures should include supportive care, which may involve symptomatic treatment and monitoring of vital signs. In cases where the specific antidote or treatment protocol is known, it should be administered as per established guidelines.

Healthcare professionals are encouraged to consult relevant toxicology resources or poison control centers for guidance on managing suspected overdosage cases effectively.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion of the medication, it is crucial to contact a physician or the Poison Control Center immediately. This prompt action is essential to ensure the safety and well-being of the patient. Providers should emphasize the importance of not waiting for symptoms to appear before seeking help.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15-30°C (59-86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Comfortcaine, 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 Comfortcaine, 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.