FDA.reportPublic FDA data

ANTIBACTERIAL

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:36:44

Label at a glance#

ProductANTIBACTERIAL
Active ingredientBENZALKONIUM CHLORIDE
Label structure13 sections

Dosage and administration

wet hands apply palmful to hands scrub thoroughly rinse thoroughly

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 handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only: hands only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • 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

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, lauramine oxide, cocamidopropyl betaine, lauramidopropylamine oxide, sodium chloride, myristamidopropylamine oxide, glycerin, fragrance, disteareth-75 IPDI, PEG-150 distearate, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, red 33, red 40, yellow 5

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ITASCA, IL 60143 ©TOPCO 

QUESTIONS? 1-888-423-0139

topcare@topco.com www.topcarebrands.com

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Colgate-Palmolive Company, distributor of Softsoap ®Antibacterial Hand Soap Crisp Clean Scent.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO SOFTSOAP ®ANTIBACTERIAL HAND SOAP CRISP CLEAN SCENT*

Top Care™

everyday

antibacterial

LIQUID HAND SOAP 

paraben free & formulated without phthalates

7.5 FL OZ (221 mL)

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-279-03ANTIBACTERIAL1478 mL in 1 BOTTLE, PLASTICLIQUID14782
76162-279-96ANTIBACTERIAL221 mL in 1 BOTTLE, PLASTICLIQUID2212

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-27976162-279-96, 76162-279-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C RED NO. 339DBA0SBB0LIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
EDETATE SODIUMMP1J8420LUIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
MYRISTAMIDOPROPYLAMINE OXIDE3HSF539C9TIACT
DISTEARETH-75 IPDI5365FJ30SCIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
CITRIC ACID2968PHW8QPIACT
BENZOPHENONE-41W6L629B4KIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-18monthly-update2026-06-03 17:46:20

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
ANTIBACTERIALBENZALKONIUM CHLORIDETopco Associates LLC463f3a53-921a-65cb-e063-6394a90ab4f22026-02-04Warnings, Adverse reactionsExact identifier
ndc (package): 76162-279-03
ndc (package): 76162-279-96
ndc (product): 76162-279
ndc11 (package): 76162027996
ndc11 (package): 76162027903
spl id: 4a014918-5eb6-c2ee-e063-6394a90ae746
spl set id: 463f3a53-921a-65cb-e063-6394a90ab4f2

Reported adverse events (FAERS/openFDA)#

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