FDA.reportPublic FDA data

Complete Lotion Hand Soap with 0.14% Benzalkonium Chloride

Manufacturer
Simoniz Saniclean, LLC
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:40:06

Label at a glance#

ProductComplete
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antimicrobial

INDICATIONS & USAGE SECTION

Uses

For handwashing to decrease bacteria on skin.

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

On infants under 6 months of age.

OTC - WHEN USING SECTION

When using this product

  • Avoid contact with eyes.
  • In case of eye contact, flush with water for 15 minutes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

Irritation or redness develops.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, drink a large quantity of water and seek medical help or contact a poison control center.

DOSAGE & ADMINISTRATION SECTION

Directions

Apply a small amount to wet hands, and rub lightly together to produce a rich lather. Rinse hands thoroughly with water, and dry skin with a clean towel.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature.
  • Do not use if you have ever had an allergic reaction to this product or any of its ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
water; PEG-7 glyceryl cocoate; lauramine oxide; glycerin; fragrance (linalool, (+/-)-; .alpha.-amylcinnamaldehyde; butylphenyl methylpropional; geraniol; coumarin; benzyl salicylate); anhydrous citric acid; edetate disodium; FD&C yellow no. 5; D&C red no. 33

SPL UNCLASSIFIED SECTION

LOT

EXP:

Simoniz Saniclean, LLC

299 Dividend Road

Rocky Hill, CT 06067

1-800-227-5536

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SaniClean

SIMONIZ

HAND CARE

Complete

Lotion Hand Soap

with

Benzalkonium Chloride

NET CONTENTS: 1 U.S. gallon (378 l)

Bottle LabelBottle Label

Case LabelCase Label

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130732009764170GTIN-13: 0732009764170
EAN-13: 0732009764170
GTIN-12: 732009764170
UPC-A: 732009764170
GTIN storage (14 digits): 00732009764170		Complete Hand Soap with BKC (004 - 1G) Rev. 0.jpg
BarcodeITF00732009764170GTIN-14: 00732009764170
GTIN-12: 732009764170
UPC-A: 732009764170
EAN-13: 0732009764170
GTIN storage (14 digits): 00732009764170		Complete Hand Soap with BKC (004 - 1G Case) Rev. 0.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63900-101-01Complete3785 mL in 1 BOTTLE, PLASTICSOAP37851
63900-101-02Complete4 in 1 BOXSOAP41

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63900-10163900-101-01, 63900-101-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURAMINE OXIDE4F6FC4MI8WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
.ALPHA.-AMYLCINNAMALDEHYDEWC51CA3418IACT
GERANIOLL837108USYIACT
WATER059QF0KO0RIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
BENZYL SALICYLATEWAO5MNK9TUIACT
COUMARINA4VZ22K1WTIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
LINALOOL, (+/-)-D81QY6I88EIACT
EDETATE DISODIUM7FLD91C86KIACT

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
CompleteBENZALKONIUM CHLORIDESimoniz Saniclean, LLC41ed32ea-5a3b-fa50-e063-6394a90a20c42025-10-27WarningsExact identifier
ndc (package): 63900-101-01
ndc (package): 63900-101-02
ndc (product): 63900-101
ndc11 (package): 63900010102
ndc11 (package): 63900010101
spl id: 41ed3320-484f-c859-e063-6294a90a3cb5
spl set id: 41ed32ea-5a3b-fa50-e063-6394a90a20c4

Reported adverse events (FAERS/openFDA)#

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