FDA.reportPublic FDA data

Simple Hygiene Antibacterial Hand

Manufacturer
FULLER INDUSTRIES, INC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:58:14

Label at a glance#

ProductSimple Hygiene Antibacterial Hand
Active ingredientCHLOROXYLENOL
Label structure6 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

  • irritation 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 ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, FD&C Blue No. 1, FD&C Yellow No. 5, Fragrance, Isopropanol, Lauramine Oxide, Propylene Glycol, Sodium Olefin Sulfonate, Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60933-210-00Simple Hygiene Antibacterial Hand1000 mL in 1 BAGAEROSOL, FOAM10005
60933-210-00Simple Hygiene Antibacterial Hand6 in 1 PACKAGEAEROSOL, FOAM65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60933-210SIMPLE HYGIENE ANTIBACTERIAL HAND (CHLOROXYLENOL) AEROSOL, FOAM [FULLER INDUSTRIES, INC]5Current NDC, Legacy NDC, 2 package rows20231030_a094c58d-5304-4132-8614-b9c0d5942e01.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
60933-21060933-210-00

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 BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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 HandCHLOROXYLENOLFULLER INDUSTRIES, INCa094c58d-5304-4132-8614-b9c0d5942e012023-10-28WarningsExact identifier
ndc (package): 60933-210-00
ndc (product): 60933-210
ndc11 (package): 60933021000
spl id: 08c07ef8-6cd5-bd48-e063-6294a90a51b9
spl set id: a094c58d-5304-4132-8614-b9c0d5942e01

Reported adverse events (FAERS/openFDA)#

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