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Comfortox Benzocaine

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This product has been discontinued

Active ingredient
Benzocaine 20 mg/100 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
Benzocaine 20 mg/100 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, Inc.
Registration number
M017
NDC root
54723-999
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, insect bite, or other minor skin issues, this product can help soothe your discomfort. It's important to use it as directed to ensure you get the best results.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor skin irritations. Whether it's a small rash, insect bite, or other minor skin issues, this treatment can help soothe your discomfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

You can use this medication for treating affected areas on your skin. If you are an adult or a child who is two years old or older, apply it to the affected area no 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 this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be mindful of your health when using this medication. If your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, you should stop using the medication and consult your doctor. This ensures that you receive the appropriate care and guidance for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

This product is intended for external use only, so be sure to avoid contact with your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days or improve and then return within a few days, it's important to stop using the product and consult your doctor.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes. If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then return within a few days. It's important to take these precautions 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, 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.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your health and circumstances.

Since there are no special precautions mentioned regarding use during pregnancy, maintaining open communication with your doctor about any medications you are considering is essential for ensuring the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your physician before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Since the effects on infants who are breastfed have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When using this product 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 (a medical doctor) before use. Always keep the product out of reach of children to prevent accidental ingestion. If the product is swallowed, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

When considering Comfortox Benzocaine for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are caring for an older adult, it’s always a good idea to consult with a healthcare professional before starting any new medication. They can help ensure that the treatment is appropriate and safe based on individual health needs.

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 for patients with 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 detailed guidelines available regarding how the medication may affect you or how your liver health might influence the treatment.

Since liver function can impact how medications work in your body, it's always a good idea to discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure that you are monitored appropriately.

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 best performance of your product, it's important to store it in a cool, dry place, away from excessive heat and direct sunlight. This will help maintain its effectiveness and safety.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

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 of age, you should consult a physician.

How often can I apply this drug?

You can apply it to the affected area not more than 3 or 4 times daily.

Are there any warnings I should be aware of?

Yes, this product is for external use only, and you should avoid contact with eyes.

What should I do if the condition worsens?

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

What should I do if the product is swallowed?

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

Is this drug safe to use during pregnancy?

The insert does not provide specific information regarding use during pregnancy, so consult your physician for advice.

Can nursing mothers use this drug?

Nursing mothers should consult a physician before using this product, as there is a potential for excretion in breast milk.

Are there any contraindications for this drug?

No contraindications are specified in the provided text.

How should I store this product?

You should protect this product from excessive heat or direct sun.

Packaging Info

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

Packaging configurations for Comfortox Benzocaine.
Details

Drug Information (PDF)

This file contains official product information for Comfortox Benzocaine, 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 provided in a packet form.

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 reported for 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. It is essential to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two 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 identified for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

In the event of accidental ingestion, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to stop the use of the product and seek medical advice.

Side Effects

Patients should be aware that the product is intended for external use only and should avoid contact with the eyes.

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

Packaging & NDC

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

Packaging configurations for Comfortox Benzocaine.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the product to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use. Care should be taken to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Comfortox Benzocaine. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the lack of targeted clinical findings or recommendations for this population. It is advisable to monitor elderly patients closely for any adverse effects or unusual responses to treatment, considering their potential for altered pharmacokinetics and increased sensitivity to medications.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential.

Lactation

Nursing mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

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

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should also be informed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is important for patients to understand the significance of these actions to ensure their safety and well-being.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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