FDA.reportPublic FDA data

Antibacterial

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:48:21

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 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

  • if irritation and redness develop
  • comdition 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, blue 1, red 33

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by the Colgate-Palmolive Company, distributor of Softsoap Antibacterial Hand Soap White Tea & Berry.

Adverse reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satsifaction Guaranteed! (888) 309-9030

Principal Panel Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDIO SELECTION ®

berries & white tea

SCENTED

ANTIBACTERIAL HAND SOAP

Compare to Softsoap ® Antibacterial Hand Soap White Tea & Berry*

Paraben Free

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 SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-897-03Antibacterial1478 mL in 1 BOTTLE, PLASTICSOAP14783
75712-897-96Antibacterial221 mL in 1 BOTTLE, PLASTICSOAP2213

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75712-89775712-897-03, 75712-897-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
SODIUM CHLORIDE451W47IQ8XIACT
MYRISTAMIDOPROPYLAMINE OXIDE3HSF539C9TIACT
GLYCERINPDC6A3C0OXIACT
DISTEARETH-75 ISOPHORONE DIISOCYANATE5365FJ30SCIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
SULISOBENZONE1W6L629B4KIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
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
AntibacterialBENZALKONIUM CHLORIDEOld East Main Co.3effae93-fd00-4aac-a42f-b5b67123f8512026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 75712-897-03
ndc (package): 75712-897-96
ndc (product): 75712-897
ndc11 (package): 75712089703
ndc11 (package): 75712089796
spl id: 4c1088b2-e7a4-ff3a-e063-6394a90a5b3e
spl set id: 3effae93-fd00-4aac-a42f-b5b67123f851

Reported adverse events (FAERS/openFDA)#

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