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Benz O Sthetic

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This product has been discontinued

Active ingredient
Benzocaine 20 g/100 g
Other brand names
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 2015
Label revision date
August 10, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 g
Other brand names
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 2015
Label revision date
August 10, 2016
Manufacturer
Geritrex LLC
Registration number
part356
NDC root
54162-926
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 be applied directly to the affected area of your gums using a cotton applicator or your fingertip. It is typically used to help manage gum issues, and you may apply it up to four times a day or as directed by your dentist.

While the specific name of the drug isn't mentioned, its purpose is to provide targeted relief for gum discomfort. If you have any questions about how to use it or its effectiveness, be sure to consult with your dentist for personalized advice.

Uses

You can use this medication to help treat specific issues in your gums. Simply apply it with a cotton applicator or your fingertip to the affected area up to four times a day, or follow your dentist's instructions for use.

It's important to note that this medication has not been shown to cause any teratogenic effects (which means it doesn't harm fetal development) or nonteratogenic effects (which refers to effects that don't cause birth defects). Always consult with your dentist if you have any questions or concerns about its use.

Dosage and Administration

When using this medication, it's important to follow the guidelines carefully. You should not use it for more than 7 days. This limit helps ensure your safety and the effectiveness of the treatment. If you find that you still need relief after this period, be sure to consult your healthcare provider for further advice. Always prioritize your health and well-being by adhering to these instructions.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

If you have a history of allergies to local anesthetics like Procaine, Benzocaine, or other “Caines,” it’s important not to use this product, as it could trigger a serious allergic reaction. Additionally, this product is not recommended for children under the age of 2. Please keep these warnings in mind to ensure your safety.

Warnings and Precautions

You should avoid using this product if you have ever had an allergic reaction to local anesthetics, such as Procaine, Benzocaine, or any other medications that end with “Caine.” Additionally, this product is not recommended for children under the age of 2, so please consult your healthcare provider if you have any concerns about its use in young children.

If you experience any unusual symptoms or reactions while using this product, stop using it immediately and contact your doctor for further guidance. It's important to prioritize your health and safety, so don't hesitate to seek medical help if needed.

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 intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the drug insert for Benz-O-Sthetic (benzocaine gel) does not provide specific warnings, precautions, or dosage changes related to its use during pregnancy. Additionally, it does not state whether the product is contraindicated (not recommended) for pregnant individuals or if there are any potential risks to your baby.

While there are no explicit concerns mentioned, it's always best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your developing baby.

Lactation Use

If you are breastfeeding, it's important to be aware that the information regarding the effects of certain medications on nursing mothers and lactation (the process of producing breast milk) is not specifically addressed in the available guidelines. This means that there may not be clear recommendations or data on how these medications could affect your milk production or your baby.

As a breastfeeding mother, it's always best to consult with your healthcare provider about any medications you are considering. They can help you understand any potential risks and make informed decisions that prioritize both your health and your baby's well-being.

Pediatric Use

It's important to know that this medication is not recommended for children under the age of 2. If you have a child in this age group, it's best to consult with your healthcare provider for alternative options. Always prioritize your child's safety and well-being when considering any medication.

Geriatric Use

When considering medication for older adults, it's important to note that there is no specific information available regarding its use in this age group. This means that there are no established guidelines for dosage adjustments or safety precautions tailored for elderly patients. As a caregiver or someone looking out for an older adult, you should be aware that the absence of this information suggests a cautious approach.

Additionally, this medication is not recommended for children under the age of 2, which highlights the need for careful consideration of age when it comes to medication use. Always consult with a healthcare professional to ensure that any treatment is appropriate and safe for older adults.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to be aware of potential interactions when considering any medication. If you have a history of allergies to local anesthetics, such as Procaine, Benzocaine, or other medications that end with “Caine,” you should avoid using this product. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

Additionally, there are no specific interactions noted with other drugs or laboratory tests. However, it's always a good practice to talk to your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20-25°C (68-77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should apply the medication to the affected gum area using a cotton applicator or your fingertip. You can do this up to four times a day or as directed by your dentist. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

How should I apply the drug?

You should apply the drug with a cotton applicator or your fingertip to the affected gum area.

How often can I use this drug?

You can use the drug up to 4 times a day or as directed by your dentist.

Are there any age restrictions for using this drug?

This drug is not recommended for children under the age of 2.

What should I do if I have an allergy to local anesthetics?

Do not use this product if you have a history of allergy to local anesthetics such as Procaine, Benzocaine, or other 'Caines'.

How long can I use this drug?

You should not use this product for more than 7 days.

What are the storage conditions for this drug?

Store the drug at controlled room temperature between 20-25°C (68-77°F).

Are there any known drug interactions?

No specific drug interactions are mentioned in the provided text.

Is this drug safe to use during pregnancy?

The insert does not indicate whether the product is contraindicated in pregnancy or if there are any risks to the fetus.

What about nursing mothers?

The insert does not specifically address the use of this drug in nursing mothers.

Packaging Info

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

Packaging configurations for Benz O Sthetic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the topical treatment of affected gum areas. It should be applied with a cotton applicator or fingertip up to four times a day, or as directed by a dentist.

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

Dosage and Administration

The recommended duration of treatment should not exceed 7 days. Healthcare professionals are advised to monitor the patient's response to therapy closely during this period. If symptoms persist beyond this timeframe, reevaluation of the patient's condition and consideration of alternative therapies is recommended.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

The use of this product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to Procaine, Benzocaine, or other agents within the “Caine” class. Healthcare professionals should exercise caution and ensure that patients are screened for such allergies prior to administration.

Additionally, this product is not recommended for use in children under the age of 2. The safety and efficacy of this product in this age group have not been established, and alternative treatment options should be considered for this population.

Monitoring for adverse reactions and ensuring appropriate patient selection are critical components of safe administration.

Side Effects

Patients with a history of allergy to local anesthetics, such as Procaine, Benzocaine, or other "Caines," should not use this product due to the potential for serious allergic reactions. Additionally, the use of this product is not recommended for children under the age of 2, as safety and efficacy have not been established in this population.

Careful consideration should be given to these warnings to ensure patient safety and to minimize the risk of adverse reactions.

Drug Interactions

The use of this product is contraindicated in individuals with a known history of allergy to local anesthetics, including but not limited to Procaine, Benzocaine, or other agents within the "Caine" class.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, no additional monitoring or dosage adjustments are recommended based on drug interactions.

Packaging & NDC

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

Packaging configurations for Benz O Sthetic.
Details

Pediatric Use

Pediatric patients under the age of 2 are not recommended to use this medication. Safety and efficacy have not been established in this age group, and caution should be exercised when considering treatment options for infants and toddlers.

Geriatric Use

Elderly patients may not have specific dosage adjustments or safety considerations outlined in the prescribing information. As there is no available data regarding the use of this medication in geriatric populations, healthcare providers should exercise caution when prescribing to elderly patients.

It is important to monitor these patients closely for any adverse effects or changes in response to treatment, given the lack of targeted clinical findings for this demographic. Additionally, while the medication is not recommended for children under the age of 2, the absence of information for elderly patients necessitates a careful assessment of individual patient needs and potential risks.

Pregnancy

Benz-O-Sthetic (benzocaine gel) has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus.

Healthcare professionals should consider the lack of data regarding the safety of benzocaine gel in pregnant patients when making treatment decisions. As with any medication, the potential benefits must be weighed against any unknown risks. Women of childbearing potential should be counseled accordingly, and alternative therapies may be considered if there are concerns regarding the use of this product during pregnancy.

Lactation

Lactating mothers and the effects of this medication during breastfeeding have not been specifically addressed in the prescribing information. There is no available data regarding the excretion of this medication in human breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 available in the insert text.

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 potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in a secure location.

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 a controlled room temperature, maintaining a range of 20-25°C (68-77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should apply the medication with a cotton applicator or fingertip to the affected gum area, up to four times a day or as directed by their dentist. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Benz O Sthetic, 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 Benz O Sthetic, 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.