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Walgreens

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This product has been discontinued

Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Liquid
Route
Oral
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
January 11, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 20 g/100 g
Other brand names
Dosage form
Liquid
Route
Oral
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
January 11, 2023
Manufacturer
Walgreens
Registration number
part356
NDC root
0363-5335
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

Benzocaine 20% is an oral anesthetic liquid designed to provide temporary relief from pain associated with mouth sores. It can help soothe discomfort caused by canker sores, minor irritation from dentures or orthodontic appliances, and minor injuries to the mouth or gums. This professional-strength formula is conveniently packaged in a 0.5 FL OZ (14.7 mL) container, making it easy to use when you need quick relief.

Uses

If you're dealing with discomfort from canker sores, this medication can provide temporary relief from the pain. It’s also helpful for soothing minor irritation in your mouth and gums, which can occur from wearing dentures or orthodontic appliances. Additionally, if you've experienced a minor injury to your mouth or gums, this product can assist in alleviating that discomfort as well.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

To use this medication effectively, start by drying the affected area thoroughly. Then, apply the medication directly from the applicator without diluting it. It's important to allow a few seconds for a protective film coating to form over the area.

You can use this medication up to four times a day, or follow the specific instructions given by your dentist or doctor. If you're supervising a child who is 12 years old or younger, make sure to assist them during application. For children under 2 years old, it's best to consult with a dentist or doctor before use.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not use it for more than 7 days unless your dentist or doctor specifically advises you to do so. Additionally, make sure not to exceed the recommended dosage, as doing so can lead to potential risks.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help you use it safely and effectively. Always consult with your healthcare provider if you have any questions or concerns.

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.

Be aware that if you experience a sore mouth that doesn’t improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens, you should contact your doctor or dentist. Additionally, seek medical attention if you develop swelling, a rash, or a fever.

Warnings and Precautions

This product is intended for oral use only. If you have a history of allergies to local anesthetics, such as procaine, butacaine, benzocaine, or other “caine” anesthetics, you should not use this product.

It's important to follow some precautions while using this medication. Do not use it for more than 7 days unless your dentist or doctor advises you to do so. If your sore mouth symptoms do not improve within that time, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, please contact your doctor or dentist right away. Always stick to the recommended dosage and do not exceed it.

If you accidentally swallow this product, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution and get help if you suspect an overdose has occurred. Your health and safety are the top priority.

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 generally not recommended for use 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 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 are no statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without concern for affecting your milk production or your baby's health. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

When using this product for children, it's important to keep a few guidelines in mind. If your child is 12 years old or younger, make sure they are supervised while using it. For children under 2 years of age, it's best to consult with a dentist or doctor before use to ensure safety and appropriateness.

By following these recommendations, you can help ensure that your child's experience with the product is safe and effective. Always prioritize their health and well-being by seeking professional advice when needed.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to be aware of potential interactions when using any medication. If you have a history of allergies to local anesthetics, such as procaine, butacaine, or benzocaine (often ending in “caine”), 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 talk to your healthcare provider about all medications and tests you are undergoing. This ensures your safety and helps prevent any unexpected issues.

Storage and Handling

To ensure the safety and effectiveness of your product, please follow these storage and handling guidelines. First, make sure not to purchase the product if the package has been opened, as this could compromise its integrity. Store the product in a cool, dry place at a temperature between 20 - 25°C (68-77°F). After each use, remember to close the cap tightly to prevent evaporation, which can affect the product's performance.

By adhering to these simple steps, you can help maintain the quality and safety of the product for your use.

Additional Information

You can take this medication orally, up to four times a day, or as directed by your dentist or doctor. However, do not use it for more than seven days unless advised by a healthcare professional. If your sore mouth symptoms do not improve within this time, or if you experience worsening irritation, pain, redness, swelling, rash, or fever, contact your doctor or dentist immediately.

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. Children aged 12 and under should be supervised while using this product, and for children under 2 years old, consult a dentist or doctor before use.

FAQ

What is Benzocaine 20% used for?

Benzocaine 20% is used for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, and minor injuries of the mouth or gums.

How should I use Benzocaine 20%?

To use Benzocaine 20%, dry the affected area and apply the medication undiluted with an applicator. Allow a few seconds for the coating to form, and use it up to 4 times daily or as directed by a dentist or doctor.

Are there any age restrictions for using Benzocaine 20%?

Children 12 years of age should be supervised while using this product, and for children under 2 years of age, you should consult a dentist or doctor.

What should I do if my symptoms do not improve?

If sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens, see your doctor or dentist promptly.

Can I use Benzocaine 20% if I am pregnant?

The safety of Benzocaine during pregnancy has not been established, and it is contraindicated in pregnancy due to potential risks to the fetus. Consult a healthcare provider before use.

What should I do if I accidentally swallow Benzocaine 20%?

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

How should I store Benzocaine 20%?

Store Benzocaine 20% at 20 - 25°C (68-77°F) and close the cap tightly after use to avoid evaporation.

Are there any allergy warnings for Benzocaine 20%?

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.

How long can I use Benzocaine 20%?

Do not use Benzocaine 20% for more than 7 days unless directed by a dentist or doctor.

Packaging Info

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

Packaging configurations for Walgreens.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Benzocaine 20% is an oral anesthetic liquid formulated for topical application. Each container holds 0.5 fluid ounces (14.7 mL) of the solution, which is designed to provide localized pain relief in the oral cavity.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with canker sores. It is also indicated for the alleviation of minor irritation of the mouth and gums resulting from dentures or orthodontic appliances. Additionally, this drug may be used for the relief of discomfort due to minor injuries of the mouth or gums.

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

Dosage and Administration

To ensure the formation of a long-lasting film coating, the affected area should be dried prior to application of the medication, which must be applied undiluted using an applicator. After application, it is important to allow a few seconds for the coating to form effectively.

The medication may be used up to four times daily, or as directed by a dentist or doctor. It is recommended that children aged 12 years and younger be supervised during the use of this product. For children under 2 years of age, consultation with a dentist or doctor is advised prior to use.

Contraindications

Use is contraindicated in patients who require treatment for longer than 7 days without the guidance of a dentist or doctor. Additionally, exceeding the recommended dosage is contraindicated due to the potential for adverse effects.

Warnings and Precautions

Oral use of this product is strictly indicated; it is not intended for any other route of administration. Healthcare professionals should be aware of the allergy alert associated with this product. It 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.

General precautions must be observed when administering this product. It should not be used for a duration exceeding 7 days unless specifically directed by a dentist or physician. In cases where symptoms of a sore mouth do not show improvement within this timeframe, or if there is a persistence or worsening of irritation, pain, or redness, it is imperative that the patient seeks prompt medical attention from a healthcare provider. Additionally, if any signs of swelling, rash, or fever develop, the patient should be advised to consult their doctor or dentist without delay. It is crucial to adhere to the recommended dosage and not exceed it.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals are reminded to monitor patients closely for any adverse reactions or lack of therapeutic response, particularly within the first week of treatment.

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 not use this product due to the risk of severe allergic responses.

In clinical practice, if patients experience sore mouth symptoms that do not improve within 7 days, or if they notice any irritation, pain, or redness that persists or worsens, it is crucial to seek medical attention promptly. Additionally, the development of swelling, rash, or fever should also prompt immediate consultation with a healthcare provider, such as a doctor or dentist, to ensure appropriate evaluation and management.

Drug Interactions

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should avoid the use of 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 Walgreens (benzocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Walgreens.
Details

Pediatric Use

Pediatric patients aged 12 years and older 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 dentist or doctor prior to use to assess appropriateness and safety.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants 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 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 an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include monitoring vital signs and providing supportive care as necessary. In cases where the specific substance is known, appropriate antidotes or treatments should be administered as per established protocols.

It is vital for healthcare providers to remain vigilant and act swiftly to mitigate potential complications 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 limits the assessment of potential risks associated with the compound in these areas.

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. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the medication for more than 7 days unless directed by a dentist or doctor. It is important to communicate that if symptoms of a sore mouth do not improve within this timeframe, or if they experience persistent or worsening irritation, pain, or redness, they should promptly consult their doctor or dentist. Additionally, patients should be cautioned to watch for any signs of swelling, rash, or fever, and to seek medical attention if these occur.

Finally, healthcare providers should emphasize the importance of not exceeding the recommended dosage to ensure patient safety and efficacy of the treatment.

Storage and Handling

The product is supplied in a secure package that should not be purchased if the package has been opened. It is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F) to maintain its integrity. After each use, the cap must be closed tightly to prevent evaporation and ensure optimal performance.

Additional Clinical Information

The product is administered orally and may be used up to four times daily, or as directed by a dentist or doctor. Patients are advised not to use the product for more than seven days unless instructed by a healthcare professional. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, patients should seek prompt medical attention.

Clinicians should counsel patients to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended. Children aged 12 years and younger should be supervised during use, and consultation with a dentist or doctor is advised for children under 2 years of age.

Drug Information (PDF)

This file contains official product information for Walgreens, 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 Walgreens, 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.