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Oral Analgesic

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 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 2010
Label revision date
August 17, 2010
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 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 2010
Label revision date
August 17, 2010
Manufacturer
LIFElabs, a Division of Atico International USA, INC.
Registration number
part356
NDC root
51852-101
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

You may be looking for an oral analgesic gel, which is a type of medication designed to relieve pain when taken by mouth. This gel can be used to help manage discomfort, but it's important to follow the recommended usage guidelines. Typically, you should not use it for more than seven days unless advised by a healthcare professional, and you should limit your doses to no more than four times in a 24-hour period unless directed otherwise. Always consult with your doctor or dentist if you have any questions about its use.

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 for or how it can help you is not available. If you have questions about this medication or its potential benefits, it's best to consult with a healthcare professional who can provide you with the necessary information tailored to your needs.

Dosage and Administration

To use the Oral Analgesic Gel, start by removing the cap and cutting the tip of the tube at the score mark. For adults and children aged 2 years and older, apply a small amount of the gel directly to the cavity and around the gums surrounding the teeth. You can use this gel up to four times a day, or as your doctor or dentist advises.

If you are using this product for children under 12 years old, make sure they are supervised during application. For children under 2 years of age, it’s important to consult with a doctor or dentist before use to ensure safety.

What to Avoid

If you experience a sore mouth, it's important to monitor your symptoms closely. You should stop using the product and consult a doctor if your sore mouth does not improve within 7 days. Additionally, if you notice any irritation, pain, or redness that persists or worsens, seek medical advice. It's also crucial to stop use and contact a healthcare professional if you develop swelling, a rash, or a fever. Your health and safety are paramount, so don’t hesitate to reach out for help if needed.

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 a doctor if your sore mouth symptoms do not improve within 7 days, or if you experience ongoing irritation, pain, or redness. Additionally, seek medical advice if you notice any swelling, rash, or fever.

Warnings and Precautions

You should only use this product temporarily until you can see a dentist. If you have a history of allergies to local anesthetics like procaine, butacaine, benzocaine, or other "caine" anesthetics, do not use this product.

If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately. Additionally, stop using the product and call your doctor if your sore mouth symptoms do not improve within 7 days, if you experience ongoing irritation, pain, or redness, or if you develop swelling, a rash, or a fever.

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 safety of benzocaine, a common topical anesthetic, has not been established. Due to potential risks to the fetus, benzocaine is contraindicated, meaning it should not be used during pregnancy.

Before using any product containing benzocaine, you should consult your healthcare provider to discuss your specific situation and any potential risks. Your health and the health of your baby are the top priority, so it's always best to seek professional advice.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

Pediatric Use

When using this product for children, it's important to follow specific guidelines to ensure their safety. For children under 12 years of age, you should supervise their use of the product. If your child is under 2 years old, it's best to consult with a doctor or dentist before using it.

For children aged 2 years and older, you can apply a small amount of the Oral Analgesic Gel to the cavity and the gums around the teeth. This can be done up to four times a day or as directed by a healthcare professional. Always make sure to follow these recommendations to keep your child safe and comfortable.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about your kidney health. They can provide guidance based on your individual situation.

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 medication's effectiveness or safety.

Before starting any new medication, it's crucial to discuss your liver condition with your healthcare provider. They can help determine the best approach for your treatment and ensure that you are monitored appropriately. Always keep your doctor informed about any changes in your health or liver function.

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.

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 them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15°C to 25°C (50°F to 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 the Oral Analgesic Gel by applying a small amount to the cavity and the gum area surrounding the teeth. This is suitable for adults and children aged 2 years and older, and you can use it up to four times a day or as directed by your doctor or dentist. If you are supervising a child under 12, make sure to guide them in using the product. For children under 2 years old, it's important to consult a doctor or dentist before use.

FAQ

What is the recommended usage for adults and children 2 years and older?

You should apply a small amount of Oral Analgesic Gel to the cavity and around the gum surrounding the teeth, using it up to 4 times daily or as directed by a doctor or dentist.

How long can I use this product?

Do not use this product for more than 7 days unless directed by a doctor or dentist.

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

Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days.

Are there any allergy warnings for this product?

Yes, 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 I experience irritation or pain?

Stop use and ask a doctor if irritation, pain, or redness persists or worsens.

Is this product safe for children under 12 years of age?

Children under 12 years of age should be supervised when using this product.

What should I do if I have a child under 2 years of age?

You should ask a doctor or dentist before using this product on a child under 2 years of age.

What are the storage conditions for this product?

Store the product at 15°C to 25°C (50°F to 77°F).

What should I do in case of overdose?

In cases of overdose, get medical help or contact a Poison Control Center right away.

Is this product safe to use during pregnancy?

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

Packaging Info

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

Packaging configurations for Oral Analgesic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines to determine appropriate applications for this drug. There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

To prepare the Oral Analgesic Gel for administration, the cap should be removed, and the tip of the tube should be cut at the score mark.

For adults and children aged 2 years and older, a small amount of the gel should be applied directly to the cavity and around the gums surrounding the affected teeth. This application may be performed up to four times daily or as directed by a healthcare professional.

Children under 12 years of age should be supervised during the use of this product to ensure safe and effective application. For children under 2 years of age, it is recommended to consult a doctor or dentist prior to use.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional under the following circumstances:

  • If symptoms of a sore mouth do not improve within 7 days.

  • If irritation, pain, or redness persists or worsens.

  • If swelling, rash, or fever develops.

These precautions are essential to ensure patient safety and appropriate management of potential adverse reactions.

Warnings and Precautions

Temporary use of this product is advised solely until a dental consultation can be arranged. It is imperative to note that individuals with a history of allergy to local anesthetics, including but not limited to procaine, butacaine, benzocaine, or other "caine" anesthetics, should refrain from using this product due to the risk of allergic reactions.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended without delay.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following conditions occur: sore mouth symptoms that do not show improvement within 7 days; persistent or worsening irritation, pain, or redness; or the development of swelling, rash, or fever. These symptoms may indicate a need for further evaluation and management.

Side Effects

Patients should be aware of the potential for serious allergic reactions associated with the use of this product. Specifically, individuals with a history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should refrain from using this product due to the risk of an allergic response.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if sore mouth symptoms do not improve within 7 days. Additionally, if any irritation, pain, or redness persists or worsens, or if symptoms such as swelling, rash, or fever develop, it is imperative to seek medical advice promptly. These recommendations are crucial for ensuring patient safety and addressing any adverse reactions that may arise during treatment.

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, butacaine, benzocaine, or other "caine" anesthetics.

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 Oral Analgesic (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Oral Analgesic.
Details

Pediatric Use

Pediatric patients under 12 years of age should be supervised during the use of this product. For children under 2 years of age, it is advised to consult a doctor or dentist prior to use.

For adults and children aged 2 years and older, a small amount of Oral Analgesic Gel may be applied to the cavity and around the gums surrounding the teeth. This can be done up to 4 times daily or as directed by a healthcare professional.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of benzocaine during pregnancy has not been established. Benzocaine is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants from the use of this product during lactation.

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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if sore mouth symptoms do not improve within 7 days. Additionally, they should be made aware that if irritation, pain, or redness persists or worsens, or if they experience swelling, rash, or fever, they should seek medical attention promptly.

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 temperature range of 15°C to 25°C (50°F to 77°F) to maintain its efficacy and stability. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment. Special handling needs must be observed to prevent any compromise to the product's integrity during storage and transportation.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children aged 2 years and older are advised to apply a small amount of Oral Analgesic Gel to the cavity and the surrounding gum area, with a maximum frequency of four times daily or as directed by a healthcare professional. For children under 12 years of age, supervision during application is recommended, while those under 2 years should consult a doctor or dentist before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Oral Analgesic, 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 Oral Analgesic, 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

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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.