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Benz O Sthetic

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This product has been discontinued

Active ingredient
Benzocaine 20 mL/100 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 2012
Label revision date
February 13, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 mL/100 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 2012
Label revision date
February 13, 2012
Manufacturer
Geritrex Corp.
Registration number
part348
NDC root
54162-925
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 an anesthetic that is commonly used to numb areas in the mouth or throat. When applied as a spray, it can provide relief from discomfort by blocking sensation in the targeted area. You can expect the anesthetic effect to occur within 15 to 30 seconds after application, making it a quick option for managing pain or discomfort.

For more precise application, especially in smaller areas, the drug can be used with an extension tube. This versatility allows for effective treatment in various situations where localized numbing is needed.

Uses

You can use this product for specific applications, especially in the mouth or throat. If you need to numb these areas, simply pump the spray 2-3 times or as needed. If you're treating larger areas, you can repeat the application. The numbing effect typically starts within 15 to 30 seconds, allowing for quick relief.

Additionally, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects, making it a safe option for use in the indicated areas. If you have any questions about how to use it effectively, feel free to ask your healthcare provider.

Dosage and Administration

If you have a child under 6 years old, it's important to follow the guidance of their dentist or doctor when using this medication. Always ensure that you are using it exactly as directed by a healthcare professional to ensure safety and effectiveness. If you have any questions or concerns about the dosage or administration, don't hesitate to reach out to their healthcare provider for clarification.

What to Avoid

It's important to be aware of certain considerations when using this medication. While there are no specific contraindications or "do not take" instructions provided, it's always wise to consult with your healthcare provider about your individual health circumstances.

Additionally, be mindful of the potential for misuse or dependence (which means relying on a substance in a way that can be harmful). If you have any concerns about how this medication may affect you, please discuss them with your doctor to ensure safe and effective use.

Side Effects

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

Warnings and Precautions

It's important to be cautious when using this product. If you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine, you should not use this product. Avoid spraying it into or near your eyes, and do not inhale the spray. If you're 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 immediately.

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, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you feel something is wrong, don’t hesitate to get help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of Benz-O-Sthetic has not been established. This product is contraindicated during pregnancy, meaning it should not be used due to potential risks to your developing baby. There may be specific risks associated with benzocaine, a key ingredient in this product, so it's crucial to consult your physician before considering its use.

If you are advised to use Benz-O-Sthetic, be aware that dosage modifications may be necessary, and you should only use it under the guidance of a healthcare provider. To ensure the safety of both you and your baby, avoid using this product unless specifically directed by a medical professional.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Benz-O-Sthetic while nursing. Additionally, there is no information suggesting that this medication is passed into breast milk or poses any risk to your infant. Always consult with your healthcare provider if you have any concerns about medications while breastfeeding.

Pediatric Use

When it comes to using this medication for children, it's important to follow specific guidelines. If your child is under 6 years old, make sure to use it only as directed by their dentist or doctor. This ensures that the treatment is safe and appropriate for their age and health needs. Always consult with a healthcare professional if you have any questions or concerns about your child's medication.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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, butacaine, benzocaine, or 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 health.

Storage and Handling

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

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should use this medication topically, applying a pump spray 2-3 times to the mouth or throat as needed. The anesthetic effect typically occurs within 15-30 seconds. It's important to avoid using this product near your eyes and not to exceed the recommended dosage. Limit your use to no more than 7 days unless your doctor or dentist advises 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, you should stop using the product and consult a physician.

FAQ

How should I use this drug for anesthetic purposes in the mouth or throat?

For anesthetic use, pump the spray 2-3 times or as needed. You can repeat it for larger areas.

How quickly does the anesthetic effect occur?

The anesthetic effect is reached in 15-30 seconds.

Are there any contraindications for using this drug?

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

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

Discontinue use and consult a physician if sore mouth symptoms do not improve in 5 days.

Can children use this drug?

Children under 6 years of age should use this product as directed by a dentist or doctor.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What precautions should I take when using this drug?

Avoid using it near your eyes, do not spray into or near the eyes, and do not inhale. Do not exceed the recommended dosage or use it for more than 7 days unless directed by a healthcare professional.

What should I do if I experience irritation or redness after using this drug?

If irritation, pain, or redness persists or worsens, discontinue use and consult a physician.

How should I store this drug?

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

The product is identified by the SPL code 34089-3. Further details regarding its chemical composition, structural formula, inactive ingredients, and other specific characteristics are not provided in the extracted facts.

Uses and Indications

This drug is indicated for anesthetic use in the mouth or throat. It may be administered via a pump spray, delivering 2-3 sprays as needed, with the option to repeat for larger areas. The onset of anesthetic effect occurs within 15-30 seconds.

The use of an extension tube is recommended for finer direct application to enhance precision in targeted areas.

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

Dosage and Administration

Children under 6 years of age should use the medication only as directed by a dentist or physician. It is essential that healthcare professionals assess the individual needs of each child and provide specific dosing instructions based on their clinical judgment.

Contraindications

There are no specific contraindications identified for this product. It is essential to evaluate each patient's individual health status and medical history before prescribing.

Warnings and Precautions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. The potential for severe allergic reactions necessitates careful screening for such allergies prior to administration.

This product is contraindicated for use in or near the eyes. Care should be taken to avoid contact with the ocular region, as exposure may lead to significant irritation or injury. Additionally, inhalation of the product is strictly prohibited, as it may cause respiratory complications.

When utilizing the extension tube, it is imperative to follow the guidance of a dentist or physician regarding the application in the back of the throat. Unauthorized use in this area may lead to adverse effects.

Patients must adhere to the recommended dosage and should not exceed the specified amount. Prolonged use beyond 7 days is not advised unless explicitly directed by a healthcare professional.

If symptoms of a sore mouth do not show improvement within 5 days, or if any irritation, pain, or redness persists or worsens, patients are advised to discontinue use immediately and consult a physician. Furthermore, any development of swelling, rash, or fever warrants prompt medical attention. Regular monitoring of symptoms and adherence to these precautions is essential for safe use of the product.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. It is contraindicated in individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other “caine” anesthetics.

In clinical practice, 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 reactions warrant immediate medical attention to ensure patient safety and appropriate management.

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 under 6 years of age should use this medication only as directed by a dentist or doctor. It is essential to follow professional guidance to ensure safety and efficacy in this age group.

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 prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for adverse effects may be prudent in this population, given the lack of established guidelines for geriatric use.

Pregnancy

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

Dosage modifications may be necessary for pregnant patients, and it is advised that they seek guidance from a healthcare provider regarding appropriate use. Pregnant women should avoid using this product unless directed by a healthcare professional.

Lactation

There are no specific warnings or recommendations regarding the use of Benz-O-Sthetic in lactating mothers. Additionally, there are no statements concerning the potential for excretion of Benz-O-Sthetic in breast milk or any associated risks to breastfed infants.

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 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 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 question.

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, specifically as a pump spray for anesthetic use in the mouth or throat, with a recommended application of 2-3 sprays as needed. Anesthetic effects typically occur within 15-30 seconds, and clinicians may repeat the application for larger areas if necessary.

Patients should be counseled to avoid using the product near the eyes and to adhere strictly to the recommended dosage. Usage should not exceed 7 days unless directed by a healthcare professional. Patients are advised to discontinue use and seek medical advice 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.