Xesso Neo

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Xesso Neo
Generic name
BENZOCAINE
Manufacturer
PREMIUM NATURAL COSMETICS INC
Product type
HUMAN OTC DRUG
SPL set ID
163f32cd-4e51-950a-e063-6394a90a4816
SPL ID
4162e790-93be-a4a8-e063-6294a90a6535
Version
5
Effective date
2025-10-17
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:25:20
Harmonized routes table
Harmonized routes
ORAL, TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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 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 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.

Reported adverse events (FAERS/openFDA)#

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