FDA.reportPublic FDA data

Prestige

Manufacturer
Sunburst Chemicals, Inc.
Effective date
2024-03-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:08

Label at a glance#

ProductPrestige
Active ingredientCHLOROXYLENOL
Label structure7 sections

Dosage and administration

Wet hands and forearms. Apply a small amount (5 mL) or palmful to hands and forearms. Scrub thoroughly for at least fifteen seconds. Rinse completely and dry.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 1% w/w

Purpose

OTC - PURPOSE SECTION

Skin Antimicrobial

Use

INDICATIONS & USAGE SECTION

reduces amount of bacteria on hands

Warnings

WARNINGS SECTION

For external use only. Do not use in eyes.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Not for use on children under 6 months of age.

For institutional and professional use only.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands and forearms.
  • Apply a small amount (5 mL) or palmful to hands and forearms.
  • Scrub thoroughly for at least fifteen seconds.
  • Rinse completely and dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene/Acrylates Copolymer, Tetrasodium EDTA, Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product Label - 1 Gallon ShortNeck BottleProduct Label - 1 Gallon ShortNeck Bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413257chloroxylenol 1 % Medicated Liquid SoapPSN4
413257chloroxylenol 10 MG/ML Medicated Liquid SoapSCD4
413257chloroxylenol 1 % Medicated Liquid SoapSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63621-335-14Prestige3785 mL in 1 BOTTLE, PLASTICSOAP37854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63621-335PRESTIGE (CHLOROXYLENOL) SOAP [SUNBURST CHEMICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240322_2e4bb97c-9c16-43d1-aea3-54723c7afc45.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63621-33563621-335-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
EDETATE SODIUMMP1J8420LUIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
CHLOROXYLENOL0F32U78V2QACTIB

Source Document#

Source XML

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
PrestigeCHLOROXYLENOLSunburst Chemicals, Inc.2e4bb97c-9c16-43d1-aea3-54723c7afc452024-03-21WarningsExact identifier
ndc (package): 63621-335-14
ndc (product): 63621-335
ndc11 (package): 63621033514
spl id: 14308390-5ca6-80b4-e063-6294a90a02ee
spl set id: 2e4bb97c-9c16-43d1-aea3-54723c7afc45

Reported adverse events (FAERS/openFDA)#

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