Drugplain

Xesso Neo 5 g/100mL

Benzocaine · SPRAY · PREMIUM NATURAL COSMETICS INC

No Recall History
Plain English

Xesso Neo is an over-the-counter oral spray containing benzocaine, a local anesthetic used to numb pain in the mouth and throat. This spray is available without a prescription for temporary relief of minor mouth and throat discomfort.

Key Facts

Brand Name
Xesso Neo
Generic Name
Benzocaine
NDC Code (Product)
81777-106
Manufacturer
PREMIUM NATURAL COSMETICS INC
Strength
5 g/100mL
Dosage Form
SPRAY
Route
ORAL, TOPICAL
Marketing Status
Application #
M013
Drug Class
Standardized Chemical Allergen [EPC]
Marketing Start
04/16/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

methaemoglobinaemia124 reports
drug ineffective89 reports
drug hypersensitivity61 reports
off label use59 reports
asthenia48 reports
nausea47 reports
dyspnoea38 reports
arthralgia36 reports
anxiety35 reports
amnesia33 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use Section For temporary relief of minor throat irritation, pain, and sore throat.

Dosage & Administration

Directions Apply to the affected area (one spray). Allow to remain in place for at least 15 seconds then spit out. May be repeated every two hours as needed or as directed by a health care professional.

Warnings

Warning METHEMOGLOBINEMIA WARNING: Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue-colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue, or lack of energy. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor promptly. For adult use only. Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other ‘caine’ anesthetics. Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away. As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product. Stop use and consult a doctor if difficulty in breathing occurs, swelling or fever develops, or if sore mouth or

Frequently Asked Questions

What is Xesso Neo used for?

Xesso Neo is an over-the-counter oral spray containing benzocaine, a local anesthetic used to numb pain in the mouth and throat. This spray is available without a prescription for temporary relief of minor mouth and throat discomfort.

Is Xesso Neo a controlled substance?

Xesso Neo is not classified as a controlled substance by the DEA.

What is the generic name for Xesso Neo?

The generic name for Xesso Neo is Benzocaine. There are 12 other brand versions of Benzocaine.

What is the NDC code for Xesso Neo 5 g/100mL?

The NDC (National Drug Code) for Xesso Neo 5 g/100mL is 81777-106, listed by PREMIUM NATURAL COSMETICS INC.