FDA.reportPublic FDA data

Alcohol Free Hand Sanitizer

Manufacturer
FULLER INDUSTRIES, INC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:11

Label at a glance#

ProductAlcohol Free Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

- For hand sanitizing 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 briskly until dry

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonoium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

- For hand sanitizing to decrease the bacteria on 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

OTC - STOP USE SECTION

if 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 together briskly until dry

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN4
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD4
1038799benzalkonium chloride 0.1 % Topical FoamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60933-200-00Alcohol Free Hand Sanitizer1000 mL in 1 BAGAEROSOL, FOAM10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60933-200ALCOHOL FREE HAND SANITIZER (BENZALKONIUM CHLORIDE) AEROSOL, FOAM [FULLER INDUSTRIES, INC]4Current NDC, Legacy NDC, 1 package rows20231030_0ebf85c5-21ee-4d14-b88f-d8c078791aef.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
60933-20060933-200-00

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
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
UNDECETH-7R6B5PCO2JNIACT
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
Alcohol Free Hand SanitizerBENZALKONIUM CHLORIDEFULLER INDUSTRIES, INC0ebf85c5-21ee-4d14-b88f-d8c078791aef2023-10-28WarningsExact identifier
ndc (package): 60933-200-00
ndc (product): 60933-200
ndc11 (package): 60933020000
spl id: 08c07ef8-6cc8-bd48-e063-6294a90a51b9
spl set id: 0ebf85c5-21ee-4d14-b88f-d8c078791aef

Reported adverse events (FAERS/openFDA)#

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