FDA.reportPublic FDA data

Premium Antibacterial Hand

Manufacturer
Insolcorp, LLC
Effective date
2020-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:02

Label at a glance#

ProductPremium Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Pump into dry hands and forearms, lather for atleast 15 seconds, rinse and dry.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

PURPOSE

OTC - PURPOSE SECTION

Antibacterial

USE

INDICATIONS & USAGE SECTION

For washing to decrease bacteria on the skin

WARNINGS

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. Incase of eye contact flush with water.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF irritation and redness develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, get medical help or contact a poision control
center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Pump into dry hands and forearms, lather for atleast 15 seconds, rinse and dry.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Caprylyl / Capryl Glucosides, Laurtrimonium Chloride, Cocamidoprpylamine Oxide, Citric Acid, Fragrance

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREMIUM ANTIBACTERIAL HAND SOAP

LEMON BLOSSOM

12 FL. OZ. (354 mL)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74811-002-022022-01-28C16284748780-1d6a99b3a-00dd-a426-e053-dadaa90af4c2Premium Antibacterial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74811-002-02Premium Antibacterial Hand354 mL in 1 BOTTLE, PUMPSOAP3541

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74811-002PREMIUM ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [INSOLCORP, LLC]1Legacy NDC, 1 package rows20201211_bf1dd923-9ec0-4e09-b935-32397cbf3b3e.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74811-00274811-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
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
b6212379-7311-e3e7-e053-2995a90a43bebf1dd923-9ec0-4e09-b935-32397cbf3b3e2020-12-10WarningsExact identifier
spl id: b6212379-7311-e3e7-e053-2995a90a43be
spl set id: bf1dd923-9ec0-4e09-b935-32397cbf3b3e

Reported adverse events (FAERS/openFDA)#

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