FDA.reportPublic FDA data

PRIME SOURCE E2 Foam So ap

Manufacturer
BUNZL
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:33

Label at a glance#

ProductPRIME SOURCE E2 Foam So ap
Active ingredientCHLOROXYLENOL
Label structure7 sections

Dosage and administration

Wet hands. Apply product and thoroughly cover hands with 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 decrease bacteria on the skin
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productdo 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 ifirritation 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 product and thoroughly cover hands with 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, Methylparaben, Propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66294-523-42PRIME SOURCE E2 Foam So ap1250 mL in 1 BOTTLELIQUID12503
66294-523-67PRIME SOURCE E2 Foam So ap2000 mL in 1 BOTTLELIQUID20003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66294-523PRIME SOURCE E2 FOAM SO AP (CHLOROXYLENOL) LIQUID [BUNZL]3Current NDC, Legacy NDC, 2 package rows20241222_739bf5fb-a1a9-4f22-9041-7fd80a9eef2e.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
66294-52366294-523-42, 66294-523-67

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 ACID, UNSPECIFIED FORM33X04XA5ATIACT
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
PRIME SOURCE E2 Foam So apCHLOROXYLENOLBUNZL739bf5fb-a1a9-4f22-9041-7fd80a9eef2e2024-12-19WarningsExact identifier
ndc (package): 66294-523-42
ndc (package): 66294-523-67
ndc (product): 66294-523
ndc11 (package): 66294052367
ndc11 (package): 66294052342
spl id: 29a572bb-8fb2-a7b0-e063-6294a90a5f8c
spl set id: 739bf5fb-a1a9-4f22-9041-7fd80a9eef2e

Reported adverse events (FAERS/openFDA)#

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