FDA.reportPublic FDA data

Antibacterial

Manufacturer
Brands International Corporation
Effective date
2022-09-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:37

Label at a glance#

ProductAntibacterial Lemon Sage
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient - Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antibacterial

INDICATIONS & USAGE SECTION

Use for handwashing to decrease bacteria on skin

WARNINGS SECTION

for external use only - hands only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and if condition persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Direction

* wet hands

* apply to hands

* scrub thoroughly

* rinse thoroughly

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Tetra Sodium EDTA, Methylchloroisothiazolinone, Methylisthiazolinone, Yellow 5, Fragrance (Parfum)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-452-152025-01-30C16284748780-12cef2736-7307-d83d-e063-dadaa90ab31fPurpose Antibacterial liquid hand soap- Refill

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-452-15AntibacterialLemon Sage1480 mL in 1 BOTTLE, PUMPLIQUID14801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-452ANTIBACTERIAL LEMON SAGE (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]1Legacy NDC, 1 package rows20220909_e819b2b8-c02f-dc32-e053-2995a90ac85d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-45250157-452-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM CHLORIDE451W47IQ8XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE SODIUMMP1J8420LUIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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
e819ab31-412e-5bed-e053-2a95a90a307de819b2b8-c02f-dc32-e053-2995a90ac85d2022-09-07WarningsExact identifier
spl id: e819ab31-412e-5bed-e053-2a95a90a307d
spl set id: e819b2b8-c02f-dc32-e053-2995a90ac85d

Reported adverse events (FAERS/openFDA)#

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