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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
24794-221
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 designed specifically 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

This medication is intended for use in the mouth, specifically as directed by your dentist. It can provide temporary relief from pain associated with minor dental procedures, helping to make your experience more comfortable.

Rest assured, there are no known teratogenic effects (which means it does not 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 of the product.

If you have a child under 2 years of age, please do not use this medication for them. Always consult with a healthcare professional if you have any questions or concerns about its use.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always follow the guidance provided to use it safely and effectively.

Side Effects

Using this product may lead to a serious condition called methemoglobinemia, which reduces the amount of oxygen in your blood. Symptoms to watch for 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 help.

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 assistance 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. Do not use it for more than 7 days unless your doctor advises otherwise. If your sore mouth symptoms do not 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 your 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 your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your physician regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your physician before using this medication. Your healthcare provider can help you understand any potential risks and ensure the safety of both you and your baby. Always prioritize open communication about your health and any medications you may be considering while nursing.

Pediatric Use

It’s important to be cautious when using this medication in children. You should not use it for children under 2 years of age. If you notice any symptoms of methemoglobinemia—a condition that can cause pale, gray, or blue skin (cyanosis), 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 vigilant about monitoring their health while using any medication.

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 for personalized advice. 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 kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

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, and your healthcare team is there to support you.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are taking, especially if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine. Using this product could trigger an allergic reaction in those cases.

Additionally, be aware that 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 the product before, so it's crucial to discuss any potential risks with your healthcare provider to ensure your safety.

Storage and Handling

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

When handling the device, always do so with care to maintain its integrity and effectiveness. Following these storage and handling guidelines will help ensure your product remains safe and functional 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 age restrictions for using this drug?

Do not use this drug in children under 2 years of age.

What should I do if I experience symptoms of methemoglobinemia?

Stop using the product and seek immediate medical attention if you or a child develops symptoms such as pale, gray, or blue colored skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue.

Can I use this drug if I have allergies to local anesthetics?

No, do not use this product if you have a history of allergies to local anesthetics like procaine, butacaine, or benzocaine.

How long can I use this drug?

You should not use this drug for more than 7 days unless directed by a physician. If symptoms do not improve, consult your 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.

Is it safe to use this drug during pregnancy or breastfeeding?

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

What precautions should I take when using this product?

Avoid contact with eyes; if contact occurs, flush with water. Also, keep the product out of reach of children.

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 identified by the SPL code 34089-3. No specific description details are provided in the text.

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.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with 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 note that this product is contraindicated for use in children under 2 years of age. Healthcare professionals should ensure that this age restriction is adhered to in order to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in individuals who are unable to keep it out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by pediatric patients. No other contraindications have been identified.

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.

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 crucial 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 prescribed 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 essential 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 aware that methemoglobinemia can occur even after prior use of the product. Immediate medical attention is required if 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 develop.

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 advised that the product 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 swelling, rash, or fever develops, patients should seek medical advice promptly.

The product is contraindicated for use in children under 2 years of age and should not be used for teething. Patients are also cautioned to avoid contact with the eyes; in the event of contact, the eyes should be flushed with water immediately.

It is critical not to exceed the recommended dosage. In cases where more than the advised 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 use this medication. In the event that a child develops symptoms of methemoglobinemia, such as pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, or fatigue, immediate medical attention should be sought. 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 currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when recommending this medication to lactating patients.

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, 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 currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

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 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 should be stored at a temperature range of 59° to 86°F (15° to 30°C). Care must be taken to protect the product from freezing to ensure its integrity and efficacy.

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. 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.