Xesso Neo 5% Benzocaine Oral Spray

Manufacturer
PREMIUM NATURAL COSMETICS INC | Creative Essences Inc
Effective date
2025-10-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:39:47

Label at a glance#

ProductXesso Neo
Active ingredientBENZOCAINE
Label structure8 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Warning

WARNINGS SECTION

  • 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 throat symptoms do not improve within 7 days.
  • Do not exceed the recommended dosage.
  • Keep away from fire or flames.

Keep out of reach of children section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, FD&C RED NO. 40, Glycerin, Natural Flavors, PEG-40 Hydrogenated Castor Oil, Polyvinylpyrrolidone (PVP), Sucralose, Water.

Use Section

INDICATIONS & USAGE SECTION

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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 5%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Other Information

OTHER SAFETY INFORMATION

Tamper-Evident: Do not use if tamper evident seal on the outside of the container is broken or missing.
Store at room temperature 20 - 25 C (68 - 77 F)

PDP and Back Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codexesso.us/pages/sign-up-and-claimProduct Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81777-106-04Xesso Neo59 mL in 1 BOTTLE, SPRAYSPRAY595

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81777-10681777-106-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-03-26full-release2026-06-01 00:57:44

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xesso NeoBENZOCAINEPREMIUM NATURAL COSMETICS INC163f32cd-4e51-950a-e063-6394a90a48162025-10-17WarningsExact identifier
ndc (package): 81777-106-04
ndc (product): 81777-106
ndc11 (package): 81777010604
spl id: 4162e790-93be-a4a8-e063-6294a90a6535
spl set id: 163f32cd-4e51-950a-e063-6394a90a4816

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.