FDA.reportPublic FDA data

Hand Sanitizer Fresh

Manufacturer
Harmonia de Venezuela CA
Effective date
2022-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:48

Label at a glance#

ProductHand Sanitizer Fresh
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin.

Dosage and administration

Apply a small amount into palm of hands and rub hands together briskly until dry.

Label contents#

Full prescribing information#

Active Ingredient                                                        Purpose

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride (0.1 %)--------------------- Antimicrobial

Uses

INDICATIONS & USAGE SECTION

For hand sanitizing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external uses only. / When using this products avoid contact of eyes. In case of eye contact, flush eyes with water. / Stop use and ask  a doctor if irritation or redness develops, or if conditions persists for more than 72 hours. /Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a small amount into palm of hands and rub hands together briskly until dry.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, hydroxypropyl methylcellulose, PEG-12 dimethicone, fragance, DMDM hydantoin, FD&C Blue No. 1 

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049228benzalkonium chloride 0.1 % Topical GelPSN3
1049228benzalkonium chloride 0.001 MG/MG Topical GelSCD3
1049228benzalkonium chloride 0.1 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73360-003-012024-01-30C16284748780-11030e364-fdcc-111a-e063-dadaa90a10e2Drug Facts
73360-003-022024-01-30C16284748780-11030e364-fdcc-111a-e063-dadaa90a10e2Drug Facts
73360-003-032024-01-30C16284748780-11030e364-fdcc-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73360-003-01Hand Sanitizer Fresh4 in 1 CARTONGEL43
73360-003-01Hand Sanitizer Fresh28 mL in 1 BOTTLEGEL283
73360-003-02Hand Sanitizer Fresh3 mL in 1 POUCHGEL33
73360-003-02Hand Sanitizer Fresh100 in 1 CARTONGEL1003
73360-003-03Hand Sanitizer Fresh28 mL in 1 BOTTLEGEL283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73360-003HAND SANITIZER FRESH (BENZALKONIUM CHLORIDE) GEL [HARMONIA DE VENEZUELA CA]3Legacy NDC, 5 package rows20221231_3ff28d6a-4ab5-433e-9bed-669a015e6156.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73360-00373360-003-01, 73360-003-02, 73360-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
DMDM HYDANTOINBYR0546TOWIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
f10c9f3c-c0fd-8574-e053-2a95a90a3a633ff28d6a-4ab5-433e-9bed-669a015e61562022-12-30WarningsExact identifier
spl id: f10c9f3c-c0fd-8574-e053-2a95a90a3a63
spl set id: 3ff28d6a-4ab5-433e-9bed-669a015e6156

Reported adverse events (FAERS/openFDA)#

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