FDA.reportPublic FDA data

Simple Hygiene Antibacterial Foam Hand

Manufacturer
Fuller Industries, LLC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:11

Label at a glance#

ProductSimple Hygiene Antibacterial Foam Hand
Active ingredientCHLOROXYLENOL
Label structure8 sections

Indications and uses

For hand washing to decrease the bacteria on skin. Recommended for repeated use

Dosage and administration

Pump a small amount of foam into palm of hand Rub thoroughly over all surfaces of both hands Rub hands together to produce a thick lather Rinse and repeat

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.5%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand washing to decrease the bacteria on skin.
  • Recommended for repeated use

Warnings

WARNINGS SECTION

For external use only

Do not use 

OTC - DO NOT USE SECTION

in the eyes. In case of contact, flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritatation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Pump a small amount of foam into palm of hand
  • Rub thoroughly over all surfaces of both hands
  • Rub hands together to produce a thick lather
  • Rinse and repeat

Inactive Ingerdients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Yellow No. 6, D&C Red No. 33, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Oletin Sulfonate, Water

Package Labeling:60933-106-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:60933-106-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:60933-106-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
436367chloroxylenol 0.5 % Medicated Liquid SoapPSN2
436367chloroxylenol 5 MG/ML Medicated Liquid SoapSCD2
436367chloroxylenol 0.5 % Medicated Liquid SoapSY2

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
60933-106-01Simple Hygiene Antibacterial Foam Hand3790 mL in 1 BOTTLESOAP37902
60933-106-02Simple Hygiene Antibacterial Foam Hand1000 mL in 1 BAGSOAP10002
60933-106-02Simple Hygiene Antibacterial Foam Hand6 in 1 CASESOAP62
60933-106-03Simple Hygiene Antibacterial Foam Hand3790 mL in 1 BOTTLESOAP37902
60933-106-03Simple Hygiene Antibacterial Foam Hand4 in 1 CASESOAP42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60933-106SIMPLE HYGIENE ANTIBACTERIAL FOAM HAND (CHLOROXYLENOL) SOAP [FULLER INDUSTRIES, LLC]2Current NDC, Legacy NDC, 5 package rows20231030_184a8dd5-1586-4a24-9ed8-32a8a45bc9b7.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60933-10660933-106-01, 60933-106-02, 60933-106-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C RED NO. 339DBA0SBB0LIACT
ISOPROPYL ALCOHOLND2M416302IACT
LAURAMINE OXIDE4F6FC4MI8WIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
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
Simple Hygiene Antibacterial Foam HandCHLOROXYLENOLFuller Industries, LLC184a8dd5-1586-4a24-9ed8-32a8a45bc9b72023-10-28WarningsExact identifier
ndc (package): 60933-106-01
ndc (package): 60933-106-02
ndc (package): 60933-106-03
ndc (product): 60933-106
ndc11 (package): 60933010601
ndc11 (package): 60933010603
ndc11 (package): 60933010602
spl id: 08bff442-7d29-56d5-e063-6394a90a6477
spl set id: 184a8dd5-1586-4a24-9ed8-32a8a45bc9b7

Reported adverse events (FAERS/openFDA)#

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