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Xesso Neo

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Active ingredient
Benzocaine 5 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Spray
Routes
  • Oral
  • Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
October 17, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Benzocaine 5 g/100 mL
Other brand names
Drug class
Standardized Chemical Allergen
Dosage form
Spray
Routes
  • Oral
  • 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 2024
Label revision date
October 17, 2025
Manufacturer
PREMIUM NATURAL COSMETICS INC
Registration number
M013
NDC root
81777-106
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 find this medication helpful for the temporary relief of minor throat irritation, pain, and sore throat. It is designed to soothe discomfort and provide a sense of relief when you are experiencing these symptoms. If you have any questions about how it works or its specific uses, feel free to ask your healthcare provider for more information.

Uses

You can use this medication for the temporary relief of minor throat irritation, pain, and sore throat. It’s designed to help soothe discomfort in your throat, making it easier for you to go about your day. If you're experiencing these symptoms, this medication may provide the relief you need.

Dosage and Administration

To use this medication, start by applying one spray directly to the affected area. After spraying, it's important to let the medication sit for at least 15 seconds before you spit it out. This allows the medication to work effectively on the area.

You can repeat this process every two hours if needed, or follow the instructions given by your healthcare professional. Always make sure to follow their guidance for the best results.

What to Avoid

It's important to keep this medication and all other drugs out of reach of children. If you suspect an accidental overdose, please seek medical help immediately or contact a Poison Control Center. This precaution helps ensure the safety of everyone in your household.

Side Effects

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

Additionally, if you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor right away. It's important to avoid this product if you have a known allergy to local anesthetics, such as procaine or benzocaine. If you experience difficulty breathing, swelling, fever, or if your sore throat symptoms do not improve within a week, stop using the product and contact your doctor.

Warnings and Precautions

Using this product comes with some important warnings and precautions. One serious risk is methemoglobinemia, a condition that can reduce the oxygen in your blood. If you or a child experiences symptoms like pale, gray, or blue skin, headache, rapid heart rate, shortness of breath, dizziness, fatigue, or lack of energy, stop using the product immediately and seek emergency medical help.

If you have a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor right away. It's also crucial to avoid this product if you have a known allergy to local anesthetics, such as procaine or benzocaine. Always keep medications out of reach of children, and in case of an accidental overdose, contact a medical professional or Poison Control Center immediately. If you are pregnant or nursing, consult your healthcare provider before use, and do not exceed the recommended dosage. If you experience difficulty breathing, swelling, fever, or if sore throat symptoms do not improve within a week, stop using the product and consult your doctor.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or call a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Don’t wait to see if symptoms improve; getting prompt assistance can be crucial. Always prioritize your health and safety by reaching out for help right away.

Pregnancy Use

If you are pregnant or nursing, it’s important to consult with your healthcare professional before taking any medication. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your healthcare professional before taking any medication. This is crucial because some drugs can affect your milk production or may be passed to your baby through breast milk. Always prioritize your health and your baby's well-being by seeking professional advice.

Pediatric Use

This product is intended for adult use only and should not be given to children. It's important to keep all medications out of reach of children to prevent accidental ingestion. If you suspect that a child has taken this medication, seek medical help or contact a Poison Control Center immediately.

Be aware that this product may cause a serious condition called methemoglobinemia, which can reduce the amount of oxygen in the blood. If you notice any signs in yourself or a child, such as pale, gray, or blue skin (known as cyanosis), headache, rapid heart rate, shortness of breath, dizziness, fatigue, or lack of energy, stop using the product and seek medical attention right away.

Geriatric Use

It's important to note that this medication is intended for adult use only, which means it may not be suitable for older adults. If you are caring for an older adult, be aware that their specific health needs and conditions should be considered when discussing treatment options. Always consult with a healthcare professional to ensure that any medication is appropriate and safe for their use.

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 the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20 - 25°C (68 - 77°F). It's important to check the container before use; do not use the product if the tamper-evident seal on the outside is broken or missing, as this indicates that the product may have been compromised.

By following these simple storage and handling guidelines, you can help maintain the quality and safety of the product. Always handle it with care to ensure it remains in optimal condition for your use.

Additional Information

No further information is available.

FAQ

What is this drug used for?

This drug is used for temporary relief of minor throat irritation, pain, and sore throat.

How should I use this product?

Apply one spray to the affected area, allow it to remain for at least 15 seconds, then spit it out. You may repeat this every two hours as needed or as directed by a healthcare professional.

Are there any warnings I should be aware of?

Yes, this product may cause methemoglobinemia, a serious condition that reduces oxygen in the blood. Seek immediate medical attention if you experience symptoms like pale or blue-colored skin, headache, or shortness of breath.

What should I do if my sore throat persists?

If your sore throat is severe, lasts more than 2 days, or is accompanied by fever, headache, or other symptoms, consult a doctor promptly.

Who should not use this product?

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

What should I do in case of accidental overdose?

Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center immediately.

Is this product safe to use during pregnancy or nursing?

As with any drug, consult a healthcare professional if you are pregnant or nursing before using this product.

How should I store this product?

Store at room temperature between 20 - 25°C (68 - 77°F) and do not use if the tamper evident seal is broken or missing.

Packaging Info

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

Packaging configurations for Xesso Neo.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available.

Uses and Indications

This drug is indicated for the temporary relief of minor throat irritation, pain, and sore throat. There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The medication should be applied to the affected area using one spray. After application, it is essential to allow the spray to remain in place for a minimum of 15 seconds before spitting it out. This process may be repeated every two hours as needed or as directed by a healthcare professional.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep this and all medications out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted.

Warnings and Precautions

Use of this product may lead to methemoglobinemia, a rare but serious condition characterized by reduced oxygen transport in the blood. Healthcare professionals should be vigilant for 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. If these symptoms occur, it is imperative to discontinue use immediately and seek urgent medical attention.

In cases of severe sore throat that persists for more than two days, or if accompanied by fever, headache, rash, swelling, nausea, or vomiting, patients should be advised to consult a physician promptly. This product is intended for adult use only.

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other ‘caine’ anesthetics, should not use this product.

It is essential to keep this and all medications out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

As with any medication, it is advisable for individuals who are pregnant or nursing to consult a healthcare professional prior to use. Additionally, patients should be instructed to seek medical advice before using this product.

If difficulty in breathing occurs, or if swelling or fever develops, or if symptoms of a sore mouth or throat do not improve within seven days, patients should discontinue use and consult a physician.

Healthcare professionals should emphasize the importance of adhering to the recommended dosage and advise patients to avoid exposure to fire or flames while using this product.

Side Effects

The use of this product may lead to serious adverse reactions, including methemoglobinemia, a rare but significant condition that can diminish 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 exhibit 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, patients should be aware of the potential for severe sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. This product is intended for adult use only.

Patients with a known history of allergy to local anesthetics, including procaine, butacaine, benzocaine, or other ‘caine’ anesthetics, should not use this product. Furthermore, individuals should discontinue use and seek medical advice if they experience difficulty in breathing, swelling, or fever, or if symptoms of a sore mouth or throat do not improve within 7 days.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Xesso Neo.
Details

Pediatric Use

The use of this product is contraindicated in pediatric patients, as it is intended for adult use only. Caution is warranted due to the potential risk of methemoglobinemia, a rare but serious condition that can occur with this medication. Methemoglobinemia reduces the oxygen-carrying capacity of the blood and requires prompt treatment. Healthcare professionals should advise caregivers to 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, it is crucial to keep this and all medications out of reach of children. In the event of an accidental overdose, caregivers should seek medical help or contact a Poison Control Center immediately.

Geriatric Use

Elderly patients are not the intended population for this medication, as it is indicated for adult use only. Therefore, the safety and efficacy of this medication in geriatric patients have not been established. Healthcare providers should exercise caution when considering the use of this medication in elderly patients, as the lack of specific data may necessitate careful monitoring and evaluation of potential risks versus benefits.

Pregnancy

Pregnant patients and those who are nursing should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this drug in breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended for nursing mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified cases of methemoglobinemia associated with the use of benzocaine products. Methemoglobinemia is a rare but serious condition that reduces the amount of oxygen carried in the blood. These cases were reported voluntarily or through surveillance programs, highlighting the importance of monitoring for this adverse event in patients using benzocaine-containing products.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of reach of children. It is important to emphasize the potential risks associated with accidental overdose. Patients should be instructed to seek medical help or contact a Poison Control Center immediately in the event of an overdose. This information is crucial for ensuring the safety and well-being of both patients and their families.

Storage and Handling

The product is supplied in a container that must be stored at room temperature, specifically within the range of 20 to 25°C (68 to 77°F). It is imperative that the tamper-evident seal on the outside of the container remains intact; the product should not be used if this seal is broken or missing.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Xesso Neo, 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 Xesso Neo, 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

Last AI update:

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.