FDA.reportPublic FDA data

Antibacterial

Manufacturer
Flex Beauty Labs
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:33

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Wash hands and rinse

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antibacterial

INDICATIONS & USAGE SECTION

Use help eliminate bacteria on hands

Warnings 

WARNINGS SECTION

For external use only

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes.In case of contact, flush and rinse with water.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Except under adult supervision. DO NOT EAT DRINK.

Keep away from food,drink and animal feeding stuffs,

If swallowed get medical help or contact posion control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash hands and rinse

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4,Benzyl Alcohol,Limonene.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VISIBILEVISIBILE

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 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72308-012-012022-01-28C16284748780-1d6a99b39-7583-a426-e053-dadaa90af4c2Antibacterial, Triclosan free- Visibly Clean Hand Soap- White Tea Berry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72308-012-01Antibacterial325 mL in 1 BOTTLE, PLASTICLIQUID3253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72308-012ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [FLEX BEAUTY LABS]3Legacy NDC, 1 package rows20200623_24944a8c-b74b-448c-abfe-bd4c9b8be0a0.zip

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
72308-01272308-012-01

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
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SULISOBENZONE1W6L629B4KIACT
BENZYL ALCOHOLLKG8494WBHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
LIMONENE DIEPOXIDEM6TUW5WEJ9IACT
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
a8b08658-1144-a47e-e053-2a95a90ad93924944a8c-b74b-448c-abfe-bd4c9b8be0a02020-06-22WarningsExact identifier
spl id: a8b08658-1144-a47e-e053-2a95a90ad939
spl set id: 24944a8c-b74b-448c-abfe-bd4c9b8be0a0

Reported adverse events (FAERS/openFDA)#

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