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Benz O Sthetic

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This product has been discontinued

Active ingredient
Benzocaine 11.8 g/59 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
September 28, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 11.8 g/59 mL
Other brand names
Dosage form
Spray
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 2017
Label revision date
September 28, 2017
Manufacturer
Geritrex LLC
Registration number
part348
NDC root
54162-929
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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Drug Overview

It seems that the information provided does not include any specific details about a drug, such as its name, purpose, or mechanism of action. Without these key facts, I am unable to create a summary that describes what the drug is or what it is used for. If you have more information or a specific drug in mind, please share it, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

Additionally, there are no details regarding any potential teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

You can use this medication to help numb the mouth or throat, making it easier to undergo certain procedures. If you’re an adult or a child aged 2 years and older, you can apply the spray by pumping it 2 to 3 times, up to a maximum of 4 times. If you need to numb a larger area, feel free to repeat the application as necessary. The numbing effect usually kicks in within 15 to 30 seconds, so you won’t have to wait long to feel relief.

If you’re using this medication for a child under 12 years old, it’s important that they are supervised and that you follow the instructions provided by their dentist or doctor. You may also use an extension tube for a more precise application if needed.

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

You should avoid using this product if you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics. If you experience sore mouth symptoms that do not improve within 5 days, or if you notice any irritation, pain, or redness that persists or worsens, it’s important to stop using the product and consult a physician. Additionally, seek medical advice if you develop swelling, a rash, or a fever.

Be cautious about accidental or excessive ingestion of the product. If you take more than the recommended dosage, contact a physician immediately or call a Poison Control Center for guidance.

Warnings and Precautions

You should avoid using this product if you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other “caine” anesthetics. It’s important not to spray the product into or near your eyes, and you should never inhale it. If you are using an extension tube, only spray in the back of your throat if your dentist or doctor has specifically instructed you to do so.

Make sure to follow the recommended dosage and do not use the product for more than 7 days unless your doctor or dentist advises you otherwise. If your sore mouth symptoms do not improve within 5 days, or if you experience any irritation, pain, or redness that worsens, or if you develop swelling, a rash, or a fever, stop using the product and consult your physician. In case of accidental or excessive ingestion, which means taking more than the recommended dosage, seek immediate advice from a physician or contact a Poison Control Center.

Overdose

If you accidentally take too much of this medication or exceed the recommended dosage, it’s important to act quickly. Contact your physician for immediate advice or call a Poison Control Center. They can provide you with the necessary guidance based on your situation.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms you may experience. If you notice anything concerning, don’t hesitate to seek help right away. Your health and safety are the top priority, so getting prompt medical attention is essential.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of Benz-O-Sthetic Spray has not been established. Benzocaine, the active ingredient in this spray, is not recommended for use during pregnancy due to potential risks to your developing baby. There may be associated risks with using benzocaine while pregnant, so it's crucial to consult your healthcare provider before considering this product.

While there are no specific dosage adjustments for pregnant individuals, caution is advised. It is best to avoid using Benz-O-Sthetic Spray unless your healthcare provider specifically directs you to do so. Always prioritize your health and the health of your baby by discussing any medications with your doctor.

Lactation Use

If you are a nursing mother, you can use Benz-O-Sthetic Spray without specific warnings or recommendations against it. Currently, there is no information indicating that this spray is excreted in breast milk or that it poses any risk to your infant while you are breastfeeding. Always feel free to consult with your healthcare provider if you have any concerns about medications while nursing.

Pediatric Use

When using this anesthetic spray for children aged 2 years and older, you should pump the spray 2-3 times, and this can be done up to 4 times as needed. However, if your child is under 12 years old, it's important that they are supervised while using the spray and that it is used exactly as directed by a dentist or doctor. This ensures their safety and the effectiveness of the treatment. Always consult with a healthcare professional if you have any questions or concerns about its use in your child.

Geriatric Use

While there is no specific information about the use of Benz-O-Sthetic (benzocaine spray) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide guidance tailored to your individual health needs and any potential interactions with other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to be aware that if you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or any other "caine" anesthetics, you should avoid using this product. Allergic reactions can be serious, so discussing your medical history with your healthcare provider is crucial.

Additionally, while there are no specific interactions with other drugs or laboratory tests noted, it's always a good practice to inform your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps your provider make the best decisions for your care.

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, be sure to do so with clean hands and 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 can use this medication topically, applying the pump spray 2-3 times, up to 4 times as needed for larger areas. It typically takes 15-30 seconds to feel the anesthetic effect. If you are using an extension tube, avoid spraying it in the back of your throat unless specifically instructed by your dentist or doctor.

If your sore mouth symptoms do not improve within 5 days, or if you experience any irritation, pain, or redness that worsens, or if you develop swelling, a rash, or a fever, you should stop using the product and consult a physician.

FAQ

What should I do if I have a history of allergy to local anesthetics?

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other 'caine' anesthetics.

How should I use the spray for anesthetic purposes?

For adults and children 2 years and older, pump the spray 2-3 times up to 4 times. You can repeat if needed for larger areas, and the anesthetic effect is reached in 15-30 seconds.

What precautions should I take when using this product?

Avoid spraying into or near your eyes, do not inhale, and do not exceed the recommended dosage. If you experience irritation, pain, or redness that persists or worsens, discontinue use and consult a physician.

Is it safe to use this product during pregnancy?

The safety of this product during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult your physician before use.

What should I do if sore mouth symptoms do not improve?

If sore mouth symptoms do not improve in 5 days, or if you experience swelling, rash, or fever, discontinue use and consult a physician.

Can children use this product?

Children under 12 years of age should be supervised and use the product as directed by a dentist or doctor.

What should I do in case of accidental or excessive ingestion?

If accidental or excessive ingestion occurs, contact a physician for immediate advice or call a Poison Control Center.

How should I store this product?

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

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 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 the administration of the anesthetic in adults and children aged 2 years and older, the product may be applied using an extension tube for more precise direct application. The recommended dosage involves delivering 2 to 3 pumps of the spray, which may be repeated up to 4 times as necessary for larger areas. The onset of the anesthetic effect typically occurs within 15 to 30 seconds following application.

It is essential that children under 12 years of age are supervised during use and that the product is administered strictly according to the directions provided by a dentist or physician.

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

Patients with a known history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other “caine” anesthetics, should not use this product.

Care should be taken to avoid contact with the eyes; the product must not be sprayed into or near the eyes. Inhalation of the product is also contraindicated. When utilizing the extension tube, it is imperative to refrain from spraying in the back of the throat unless specifically directed to do so by a dentist or physician.

The recommended dosage should not be exceeded, and the duration of use must not surpass 7 days unless otherwise instructed by a healthcare professional.

Patients are advised to discontinue use and seek medical consultation if any of the following occur: sore mouth symptoms do not improve within 5 days; there is a persistence or worsening of irritation, pain, or redness; or if swelling, rash, or fever develops.

In the event of accidental or excessive ingestion that exceeds the recommended dosage, immediate medical advice should be sought by contacting a physician or calling a Poison Control Center.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics. In such cases, the use of this product is contraindicated.

Patients are advised to discontinue use and consult a physician if any of the following occur: sore mouth symptoms do not improve within 5 days; irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops. These symptoms may indicate a more serious condition requiring medical attention.

Additionally, caution is warranted regarding the potential for accidental or excessive ingestion of the product. If ingestion exceeds the recommended dosage, patients should contact a physician for immediate advice or call a Poison Control Center. This precaution is essential to ensure patient safety and mitigate any risks associated with overdose.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product due to the potential for severe allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

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 aged 2 years and older may use the anesthetic in the mouth or throat by administering 2-3 pumps, up to a maximum of 4 times. It is essential that children under 12 years of age are supervised during use and that the product is administered as directed by a dentist or doctor to ensure safety and efficacy.

Geriatric Use

There is no specific information regarding the use of Benz-O-Sthetic (benzocaine spray) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for adverse effects is advisable, given the lack of established guidelines for this population.

Pregnancy

The safety of Benz-O-Sthetic Spray during pregnancy has not been established. Benzocaine, the active ingredient, is contraindicated in pregnancy due to potential risks to the fetus. There may be associated risks with the use of benzocaine during this period; therefore, it is essential for pregnant patients to consult a physician before use.

No specific dosage modifications for pregnant individuals are provided; however, caution is advised. Pregnant women should avoid using this product unless directed by a healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of Benz-O-Sthetic Spray in lactating mothers. Additionally, there are no statements concerning the potential for excretion of Benz-O-Sthetic Spray 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 event of accidental or excessive ingestion of the medication, which exceeds the recommended dosage, it is imperative to seek immediate medical advice. Healthcare professionals should instruct patients or caregivers to contact a physician without delay or reach out to a Poison Control Center for guidance.

Prompt intervention is crucial in managing potential overdosage situations. Symptoms may vary depending on the specific medication involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and established protocols.

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 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 their home environment.

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

The product is administered topically, with a recommended dosage for adults and children aged 2 years and older being 2-3 sprays, up to a maximum of 4 times. For larger areas, the application can be repeated as needed, with the anesthetic effect typically achieved within 15-30 seconds.

Patients should be counseled to avoid spraying the product in the back of the throat unless specifically directed by a dentist or physician. They are advised to discontinue use and seek medical consultation if sore mouth symptoms do not improve within 5 days, or if they experience persistent or worsening irritation, pain, or redness, as well as any signs of swelling, rash, or fever.

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.

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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.