FDA.reportPublic FDA data

Hygiene Clean Clean Cotton Hand Sanitizer

Manufacturer
USA Broom LLC
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:15

Label at a glance#

ProductHygiene Clean Clean Cotton Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 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

Benzalkonium Chloride 0.13%

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, Propylene Glycol, Lauramine Oxide, Undecth-7, Disodium EDTA; Aloe Barbadensis Gel, Glycereth-2-Cocoate; DMDM Hydantoin; Fragrance, Citric Acid

Package Labeling:237 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:5.68l

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:50ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

Package Labeling:1.2L

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box2Box2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN4
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD4
1049254benzalkonium chloride 0.13 % Topical SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80499-001-01Hygiene Clean Clean Cotton Hand Sanitizer237 mL in 1 BOTTLE, PLASTICLIQUID2374
80499-001-02Hygiene Clean Clean Cotton Hand Sanitizer24 in 1 BOXLIQUID244
80499-001-03Hygiene Clean Clean Cotton Hand Sanitizer50 mL in 1 BOTTLE, PLASTICLIQUID504
80499-001-04Hygiene Clean Clean Cotton Hand Sanitizer24 in 1 BOXLIQUID244
80499-001-04Hygiene Clean Clean Cotton Hand Sanitizer50 mL in 1 BOTTLE, PLASTICLIQUID504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80499-001HYGIENE CLEAN CLEAN COTTON HAND SANITIZER (BENZALKONIUM CHLORIDE) LIQUID [USA BROOM LLC]4Current NDC, Legacy NDC, 5 package rows20231030_affb0061-4347-7cd9-e053-2995a90ac114.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80499-00180499-001-01, 80499-001-02, 80499-001-03, 80499-001-04

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
UNDECETH-7R6B5PCO2JNIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LAURAMINE OXIDE4F6FC4MI8WIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
DMDM HYDANTOINBYR0546TOWIACT
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
Hygiene Clean Clean Cotton Hand SanitizerBENZALKONIUM CHLORIDEUSA Broom LLCaffb0061-4347-7cd9-e053-2995a90ac1142023-10-28WarningsExact identifier
ndc (package): 80499-001-04
ndc (package): 80499-001-03
ndc (package): 80499-001-02
ndc (package): 80499-001-01
ndc (product): 80499-001
ndc11 (package): 80499000102
ndc11 (package): 80499000101
ndc11 (package): 80499000103
ndc11 (package): 80499000104
spl id: 08c08704-4e9c-4151-e063-6394a90abe3a
spl set id: affb0061-4347-7cd9-e053-2995a90ac114

Reported adverse events (FAERS/openFDA)#

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