FDA.reportPublic FDA data

PURELL Healthcare HEALTHY SP 0.5pct PCMX Antimicrobial Foam

Manufacturer
GOJO Industries, Inc.
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:47:07

Label at a glance#

ProductPURELL Healthcare HEALTHY SP 0.5pct PCMX Antimicrobial Foam
Active ingredientCHLOROXYLENOL
Label structure7 sections

Dosage and administration

Wet hands Apply a small amount of product and work into a lather Rinse well and dry hands completely

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.5%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • Handwash to help reduce bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

Wwhen using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands
  • Apply a small amount of product and work into a lather
  • Rinse well and dry hands completely

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Alcohol, Lauric Acid, Ethanolamine, Dipropylene Glycol, Lactic Acid, Poloxamer 124, Isopropyl Alcohol, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Methylparaben, Propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21749-522PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]2Legacy NDC20241211_bd4682ce-6cc3-4e4c-9e64-b8ffb4ec7835.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21749-52221749-522-53, 21749-522-89, 21749-522-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
LAURIC ACID1160N9NU9UIACT
MONOETHANOLAMINE5KV86114PTIACT
DIPROPYLENE GLYCOLE107L85C40IACT
LACTIC ACID33X04XA5ATIACT
POLOXAMER 1241S66E28KXAIACT
ISOPROPYL ALCOHOLND2M416302IACT
SODIUM METABISULFITE4VON5FNS3CIACT
SODIUM SULFITEVTK01UQK3GIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM SULFATE0YPR65R21JIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
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
4654f5d3-0ac1-7c5e-e063-6294a90a3debbd4682ce-6cc3-4e4c-9e64-b8ffb4ec78352025-12-19WarningsExact identifier
spl set id: bd4682ce-6cc3-4e4c-9e64-b8ffb4ec7835

Reported adverse events (FAERS/openFDA)#

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