FDA.reportPublic FDA data

U HAND SANITIZER CLASSIC

Manufacturer
BLUE SEA AEROSOL & DAILY CARE CO., LTD
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:14

Label at a glance#

ProductU HAND SANITIZER CLASSIC
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and rub until dry without wiping For children under 6, use only under adult supervision Not recommended for infants

Storage and handling

Do not store above 105F May discolor some fabrics Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

For Hand Sanitizing

Warnings

WARNINGS SECTION

For external use only - Hands

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

OTC - STOP USE SECTION

Stop use and ask a doctor if skin irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and rub until dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN2
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD2
1049254benzalkonium chloride 0.13 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72119-004-012024-12-07C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-022024-12-07C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-032024-12-07C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-012022-01-28C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-022022-01-28C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004
72119-004-032022-01-28C16284748780-1d6a99b39-752c-a426-e053-dadaa90af4c272119-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72119-004-01U HAND SANITIZER CLASSIC100 mL in 1 BOTTLESOLUTION1002
72119-004-02U HAND SANITIZER CLASSIC200 mL in 1 BOTTLESOLUTION2002
72119-004-03U HAND SANITIZER CLASSIC473 mL in 1 BOTTLESOLUTION4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72119-004U HAND SANITIZER CLASSIC (BENZALKONIUM CHLORIDE) SOLUTION [BLUE SEA AEROSOL & DAILY CARE CO., LTD]2Current NDC, Legacy NDC, 3 package rows20241208_fbc27a24-0e81-4907-b24f-881c4fe0ec44.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72119-00472119-004-01, 72119-004-02, 72119-004-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
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
U HAND SANITIZER CLASSICBENZALKONIUM CHLORIDEBLUE SEA AEROSOL & DAILY CARE CO., LTDfbc27a24-0e81-4907-b24f-881c4fe0ec442024-12-06WarningsExact identifier
ndc (package): 72119-004-01
ndc (package): 72119-004-02
ndc (package): 72119-004-03
ndc (product): 72119-004
ndc11 (package): 72119000401
ndc11 (package): 72119000403
ndc11 (package): 72119000402
spl id: 289f021f-0aa6-af6b-e063-6394a90a15d2
spl set id: fbc27a24-0e81-4907-b24f-881c4fe0ec44

Reported adverse events (FAERS/openFDA)#

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