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Gumnumb Topical Anesthetic

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This product has been discontinued

Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
January 21, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 200 mg/1 g
Other brand names
Dosage form
Gel
Route
Dental
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 2013
Label revision date
January 21, 2022
Manufacturer
Crosstex International Inc.
Registration number
part356
NDC root
24794-220
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 specifically designed for use in the oral mucosa, which is the moist tissue lining the mouth. It is typically used as directed by a dentist to provide temporary relief from pain associated with minor dental procedures. By targeting the affected area, it helps to alleviate discomfort, making your dental experience more manageable.

Uses

You can use this medication for your oral mucosa, but only as directed by your dentist. It is specifically designed to provide temporary relief from pain associated with minor dental procedures.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always follow your dentist's instructions for the best results.

Dosage and Administration

When using this medication, apply only the amount needed directly to the oral mucosa (the moist tissue lining the mouth) to help prevent or relieve pain. It's important to use just the right amount to ensure effectiveness without wasting any product.

Please note that this medication is not suitable for children under 2 years of age, so if you have a young child, be sure to consult with a healthcare professional for appropriate alternatives. Always follow the instructions provided to ensure safe and effective use.

What to Avoid

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

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. Symptoms can include pale, gray, or blue skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness, and fatigue. If you or a child experiences any of these symptoms, stop using the product immediately and seek medical attention.

Additionally, if you have a history of allergies to local anesthetics like procaine or benzocaine, you should not use this product. It is also important to avoid using it for more than 7 days unless directed by a doctor, and it should not be used for teething or in children under 2 years old. Always avoid contact with your eyes, and if you accidentally swallow more than the recommended dose, seek medical help right away. If you are pregnant or breastfeeding, consult your physician before use.

Warnings and Precautions

Using this product may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. This can happen even if you've used it before. If you or a child experiences symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the product immediately and seek emergency medical help.

Be cautious if you have a history of allergies to local anesthetics, such as procaine or benzocaine, as this product may not be safe for you. Avoid using it for more than 7 days unless your doctor advises otherwise. If your sore mouth symptoms don’t improve, or if you notice any irritation, pain, redness, swelling, rash, or fever, contact your physician right away. This product should not be used for teething or in children under 2 years of age. Always avoid contact with your eyes, and if it happens, rinse them with water. If you accidentally take more than the recommended dose, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, consult your doctor before using this product.

Overdose

It's important to always follow the recommended dosage for any medication. If you accidentally take more than the prescribed amount, especially if it's more than what you need for pain relief, you should seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your physician regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you and your baby remain safe while breastfeeding. Always prioritize open communication with your physician regarding any medications you may consider during this time.

Pediatric Use

It’s important to be cautious when using this medication in children. You should not give it to children under 2 years of age. If your child shows any signs of methemoglobinemia (a condition where the blood can't carry oxygen properly), such as pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue, stop using the medication immediately and seek medical help.

Always keep this medication out of reach of children to prevent accidental ingestion. Your child's safety is a priority, so be sure to follow these guidelines closely.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware of potential interactions when using certain medications. 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. Additionally, this medication may lead to a serious condition called methemoglobinemia, which reduces the oxygen in your blood. This can happen even if you've used the product safely in the past.

Always discuss any medications or tests with your healthcare provider to ensure your safety and well-being. They can help you understand the risks and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at temperatures between 59°F and 86°F (15°C to 30°C). It's important to keep the product protected from freezing, as extreme cold can damage it.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help ensure that your product remains safe and effective for use.

Additional Information

The medication is administered through a dental route, meaning it is specifically used in dental settings. If you are pregnant or breastfeeding, it’s important to consult your physician before using this medication. Additionally, make sure to keep it out of reach of children to ensure their safety.

FAQ

What is the primary use of this drug?

This drug is for oral mucosa use only, as directed by your dentist, and provides temporary relief of pain due to minor dental procedures.

Are there any warnings associated with this drug?

Yes, it may cause methemoglobinemia, a serious condition that reduces oxygen in the blood. Seek immediate medical attention if you or a child develops symptoms like pale skin, headache, or shortness of breath.

Who should not use this drug?

Do not use this drug in children under 2 years of age, for teething, or for more than 7 days unless directed by a physician.

What should I do if I accidentally swallow more than the recommended dosage?

If more than the recommended amount is swallowed, seek medical help or contact a Poison Control Center immediately.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult your physician before using this drug.

Is there an allergy alert for this drug?

Yes, do not use this drug if you have a history of allergies to local anesthetics such as procaine, butacaine, or benzocaine.

How should I store this drug?

Store the drug at 59° - 86°F (15°-30°C) and protect it from freezing.

What should I do if the drug comes into contact with my eyes?

If the drug contacts your eyes, flush them with water immediately.

Packaging Info

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

Packaging configurations for Gumnumb Topical Anesthetic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a topical anesthetic formulated as a cherry-flavored gel. It contains Benzocaine as the active ingredient, which is intended for the temporary relief of pain and discomfort associated with minor oral irritations. The formulation includes several inactive ingredients: Glycerin, Propylene Glycol, Sodium Saccharin, Purified Water, Flavor, and a Color Additive (Red 40). The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for oral mucosa use only, as directed by a dentist. It is intended for the temporary relief of pain associated with minor dental procedures.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The recommended dosage involves applying only the amount necessary to the oral mucosa to effectively prevent or relieve pain. It is important to ensure that the application is limited to the affected area to achieve optimal results.

For pediatric patients, the use of this product is contraindicated in children under 2 years of age. Healthcare professionals should exercise caution and adhere to this guideline to ensure patient safety.

Contraindications

There are no contraindications listed for this product. It is important to evaluate each patient's individual circumstances and medical history before prescribing.

Warnings and Precautions

Use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This risk exists even in individuals who have previously used the product without issue. Healthcare professionals should advise patients to discontinue use and seek immediate medical attention if they or a child in their care exhibit any of the following symptoms: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue and lack of energy.

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

The product should not be used for more than 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within this timeframe, or if irritation, pain, or redness persists or worsens, or if any swelling, rash, or fever develops, patients should be advised to consult their physician promptly. Additionally, this product is contraindicated for teething and should not be administered to children under 2 years of age.

While using this product, it is essential to avoid contact with the eyes. In the event of accidental contact, the affected area should be flushed with water immediately.

Patients must not exceed the recommended dosage. In cases where an overdose occurs, such as swallowing more than the recommended amount for pain relief, immediate medical assistance should be sought or the Poison Control Center contacted.

For individuals who are pregnant or breastfeeding, it is crucial to consult a physician prior to use to ensure safety for both the mother and child.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a condition that significantly reduces the oxygen-carrying capacity of the blood. Patients should be advised to discontinue use and seek immediate medical attention if they or a child in their care experience symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue or lack of energy.

Patients with a known history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product. Additionally, it is contraindicated for use in children under 2 years of age, for teething, and for durations exceeding 7 days unless directed by a physician. If symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, patients should promptly consult their physician.

While using this product, patients should avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately. It is crucial not to exceed the recommended dosage, and if more than the intended amount is accidentally ingested, medical assistance or contact with a Poison Control Center should be sought without delay. Pregnant or breastfeeding patients are advised to consult a physician prior to use.

Drug Interactions

Patients with a history of allergies to local anesthetics, including procaine, butacaine, benzocaine, or other "caine" anesthetics, should not use this product due to the risk of allergic reactions.

The use of this product may lead to methemoglobinemia, a serious condition characterized by reduced oxygen transport in the blood. This adverse effect can occur even in patients who have previously used the product without incident. Prompt treatment is essential if methemoglobinemia is suspected. Monitoring for signs and symptoms of this condition is advised, particularly in patients with risk factors or those receiving higher doses.

Packaging & NDC

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

Packaging configurations for Gumnumb Topical Anesthetic.
Details

Pediatric Use

Pediatric patients under 2 years of age should not be administered this medication. Caution is advised due to the risk of methemoglobinemia; caregivers must seek immediate medical attention if a child exhibits symptoms such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue, or lack of energy. Additionally, this medication should be kept out of reach of children to prevent accidental ingestion.

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

Pregnant patients and those who are breastfeeding should consult a physician prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare professionals are advised to consider the individual circumstances of each patient when making recommendations regarding the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. There is no specific data available regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this medication to lactating patients.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Exceeding the prescribed amount can lead to serious health complications.

Should an individual accidentally ingest more than the recommended dosage intended for pain management, immediate medical assistance is necessary. Healthcare professionals should advise contacting a Poison Control Center or seeking emergency medical help without delay. Prompt intervention is essential to mitigate potential risks associated with overdosage.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. It is advised that individuals who are pregnant or breastfeeding consult a physician prior to use. Additionally, no data has been provided concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for methemoglobinemia associated with the use of this product. Methemoglobinemia is a serious condition that can reduce the amount of oxygen carried in the blood and requires prompt treatment. Reports indicate that this condition may occur even in individuals who have previously used the product without incident.

In cases where symptoms develop, it is advised to discontinue use and seek immediate medical attention. Symptoms to be aware of include pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, and fatigue or lack of energy.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at temperatures ranging from 59°F to 86°F (15°C to 30°C). Care should be taken to protect the product from freezing to ensure its integrity and efficacy. Proper handling and storage conditions are crucial for maintaining the quality of the product.

Additional Clinical Information

The route of administration for the product is dental. Clinicians should advise patients who are pregnant or breastfeeding to consult a physician prior to use. Additionally, it is important to keep the product out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Gumnumb Topical Anesthetic, 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 Gumnumb Topical Anesthetic, 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.