FDA.reportPublic FDA data

Antibacterial

Manufacturer
Flex Beauty Labs
Effective date
2020-07-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:20:56

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Wash hands and rinse

Label contents#

Full prescribing information#

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. 

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, Coamide Methyl MEA, Fragrance, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, DMDM Hydantoin ,Cl 14700, Cl 15510.

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

lemonlemon

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72308-013-012021-07-23C16284748780-1c7ccaba7-2718-fd44-e053-dadaa90aa01bAntibacterial- Germout Hand Soap, Triclosan free, Kitchen Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72308-013-01Antibacterial325 mL in 1 BOTTLE, PLASTICLIQUID3252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72308-013ANTIBACTERIAL (BENZALKONIUM CHLORIDE 0.13%) LIQUID [FLEX BEAUTY LABS]2Legacy NDC, 1 package rows20200711_9adce142-3a03-4732-88b0-2740c42d949f.zip

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
72308-01372308-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYSORBATE 207T1F30V5YHIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
DMDM HYDANTOINBYR0546TOWIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 4X3W0AM1JLXIACT
D&C ORANGE NO. 4Q1LIY3BO0UIACT
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
aa19a06e-fabb-5403-e053-2995a90ad6a39adce142-3a03-4732-88b0-2740c42d949f2020-07-10WarningsExact identifier
spl id: aa19a06e-fabb-5403-e053-2995a90ad6a3
spl set id: 9adce142-3a03-4732-88b0-2740c42d949f

Reported adverse events (FAERS/openFDA)#

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