FDA.reportPublic FDA data

Simple Hygiene Alcohol Free Foam Hand Sanitizer

Manufacturer
FULLER INDUSTRIES, INC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:18

Label at a glance#

ProductSimple Hygiene Alcohol Free Foam Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

• For hand sanitizing to decrease bacteria on the 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 briskly together until dry.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

• For hand sanitizing to decrease bacteria on the skin.

• Recommended for repeated use.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or redness develops, or if 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 briskly together until dry.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water; Lauramine Oxide; Undeceth-7; DisodiumEDTA; DMDM Hydantoin; Fragrance; Citric Acid; FD&C Red #33; FD&C Blue #1.

Package Labeling:237ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling: 237ml 24 bottles

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:1 gal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Package Labeling:1 gal 4 bottles

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle4Bottle4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN3
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD3
1038799benzalkonium chloride 0.1 % Topical FoamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60933-018-01Simple Hygiene Alcohol Free Foam Hand Sanitizer237 mL in 1 BOTTLELIQUID2373
60933-018-02Simple Hygiene Alcohol Free Foam Hand Sanitizer24 in 1 BOXLIQUID243
60933-018-02Simple Hygiene Alcohol Free Foam Hand Sanitizer237 mL in 1 BOTTLELIQUID2373
60933-018-03Simple Hygiene Alcohol Free Foam Hand Sanitizer3790 mL in 1 BOTTLELIQUID37903
60933-018-04Simple Hygiene Alcohol Free Foam Hand Sanitizer3790 mL in 1 BOTTLELIQUID37903
60933-018-04Simple Hygiene Alcohol Free Foam Hand Sanitizer4 in 1 BOXLIQUID43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60933-018SIMPLE HYGIENE ALCOHOL FREE FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [FULLER INDUSTRIES, INC]3Current NDC, Legacy NDC, 6 package rows20231030_b6fdf78f-4b9b-aca7-e053-2995a90a991c.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
60933-01860933-018-01, 60933-018-02, 60933-018-03, 60933-018-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECETH-7R6B5PCO2JNIACT
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DMDM HYDANTOINBYR0546TOWIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
Simple Hygiene Alcohol Free Foam Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INCb6fdf78f-4b9b-aca7-e053-2995a90a991c2023-10-28WarningsExact identifier
ndc (package): 60933-018-02
ndc (package): 60933-018-04
ndc (package): 60933-018-03
ndc (package): 60933-018-01
ndc (product): 60933-018
ndc11 (package): 60933001802
ndc11 (package): 60933001803
ndc11 (package): 60933001804
ndc11 (package): 60933001801
spl id: 08c02640-add8-7579-e063-6294a90a30fe
spl set id: b6fdf78f-4b9b-aca7-e053-2995a90a991c

Reported adverse events (FAERS/openFDA)#

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