FDA.reportPublic FDA data

Hand Sanitizer

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
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, stearic acid, cetostearyl alcohol, mineral oil, propylene glycol, trietanolamine, benzophenone-3, polysorbate 60, PEG 12-
dimethicone, glyceryl stearate, fragance, imidazolidinyl urea, propyl paraben, carbomer, tocopheryl acetate, tetrasodium EDTA, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1 , FD&C Red No. 40.

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1102185benzalkonium chloride 0.1 % Topical LotionPSN3
1102185benzalkonium chloride 1 MG/ML Topical LotionSCD3
1102185benzalkonium chloride 0.1 % Topical LotionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73360-001-012024-01-30C16284748780-11030e365-0072-111a-e063-dadaa90a10e2Drug Facts
73360-001-022024-01-30C16284748780-11030e365-0072-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73360-001-01Hand Sanitizer4 in 1 CARTONLOTION43
73360-001-01Hand Sanitizer28 mL in 1 BOTTLELOTION283
73360-001-02Hand Sanitizer28 mL in 1 BOTTLELOTION283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73360-001HAND SANITIZER (BENZALKONIUM CHLORIDE) LOTION [HARMONIA DE VENEZUELA CA]3Legacy NDC, 3 package rows20221231_7fd35605-3904-4cd2-b30c-7e5ce269de1a.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73360-00173360-001-01, 73360-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
OXYBENZONE95OOS7VE0YIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
IMIDUREAM629807ATLIACT
PROPYLPARABENZ8IX2SC1OHIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
EDETATE SODIUMMP1J8420LUIACT
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
f10cadcf-e797-9e4c-e053-2a95a90a2f367fd35605-3904-4cd2-b30c-7e5ce269de1a2022-12-30WarningsExact identifier
spl id: f10cadcf-e797-9e4c-e053-2a95a90a2f36
spl set id: 7fd35605-3904-4cd2-b30c-7e5ce269de1a

Reported adverse events (FAERS/openFDA)#

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