FDA.reportPublic FDA data

Phlo-In-A-Box Anti-Bacterial Lotion Hand Soap with 0.13% Benzalkonium Chloride

Manufacturer
Simoniz Saniclean, LLC
Effective date
2025-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:39

Label at a glance#

ProductSaniclean
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 ingested get medical help or contact a poison control right away.

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 ingredientsWater, hydroxyethyl cellulose, PEG-7 glyceryl cocoate, glycerin, lauramine oxide, fragrance, geraniol, linalool, citral, citric acid, edetate disodium, FD&C yellow no. 5, D&C red no. 33

SPL UNCLASSIFIED SECTION

Simoniz Saniclean, LLC

299 Dividend Road

Rocky Hill, CT 06067

1-800-227-5536

800 mL Bags

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHLO-IN-A-BOX ANTI-BACTERIAL
Lotion Hand Soap with Benzalkonium Chloride

Net Contents: 800 ml

Simoniz Saniclean, LLC 299 Dividend Road Rocky Hill, CT 06067 1-800-227-5536

Bag LabelBag Label

Case LabelCase Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeITF00732009241008GTIN-14: 00732009241008
GTIN-12: 732009241008
UPC-A: 732009241008
EAN-13: 0732009241008
GTIN storage (14 digits): 00732009241008		Phlo In A Box Anti-Bacterial (800 - 800 mL 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
63900-120-01Saniclean800 mL in 1 BAGSOAP8002
63900-120-02Saniclean4 in 1 BOXSOAP42

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63900-12063900-120-01, 63900-120-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LINALOOL, (+/-)-D81QY6I88EIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
D&C RED NO. 339DBA0SBB0LIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CITRALT7EU0O9VPPIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
WATER059QF0KO0RIACT
GERANIOLL837108USYIACT

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
SanicleanBENZALKONIUM CHLORIDESimoniz Saniclean, LLC41207d45-7acf-2fcf-e063-6294a90a73ea2025-11-05WarningsExact identifier
ndc (package): 63900-120-02
ndc (package): 63900-120-01
ndc (product): 63900-120
ndc11 (package): 63900012001
ndc11 (package): 63900012002
spl id: 42dc3ef6-4903-b7e4-e063-6394a90a4800
spl set id: 41207d45-7acf-2fcf-e063-6294a90a73ea

Reported adverse events (FAERS/openFDA)#

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