FDA.reportPublic FDA data

PureFoam Antibacterial Hand Wash

Manufacturer
Economy Polymers and Chemicals
Effective date
2020-11-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:34:16

Label at a glance#

ProductPureFoam Antibacterial Hand Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

For hand washing to decrease bacteria on the skin

Dosage and administration

• Wet hands and desired area. • Apply product to adequately cover the surface. • Scrub thoroughly for atleast 30 seconds. • Rinse

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.12%

Purpose

OTC - PURPOSE SECTION

Antibacterial Hand Cleaner

Uses

INDICATIONS & USAGE SECTION

  • For hand washing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

Keep away from fire and flame.

For external use only

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash appears and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Wet hands and desired area.
• Apply product to adequately cover the surface.
• Scrub thoroughly for atleast 30 seconds.
• Rinse

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), glycerin, lauramine oxide, cocamidopropyl hydroxysultaine and cocamide MIPA, cocamidpropyl PG-Dimonium Chloride Phosphate, Fragrance, Benzl Alcohol, Ethylhexylglycerin, Tocopherol, Citric Acid

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• Store between (15-20C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapPSN1
1053188benzalkonium chloride 1.2 MG/ML Medicated Liquid SoapSCD1
1053188benzalkonium chloride 0.12 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74830-547-012023-01-30C16284748780-1f386c649-dc84-0266-e053-dadaa90a7c1aPureFoam Antibacterial Hand Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74830-547-01PureFoam Antibacterial Hand Wash59.1 mL in 1 BOTTLELIQUID59.11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74830-547PUREFOAM ANTIBACTERIAL HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [ECONOMY POLYMERS AND CHEMICALS]1Legacy NDC, 1 package rows20201126_b4ef14e3-517f-223d-e053-2a95a90a926a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74830-54774830-547-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
COCAMIDE3YXD33R71GIACT
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
b4eee2c9-02de-c536-e053-2995a90ad92cb4ef14e3-517f-223d-e053-2a95a90a926a2020-11-25WarningsExact identifier
spl id: b4eee2c9-02de-c536-e053-2995a90ad92c
spl set id: b4ef14e3-517f-223d-e053-2a95a90a926a

Reported adverse events (FAERS/openFDA)#

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