FDA.reportPublic FDA data

Antibacterial

Manufacturer
Brands International Corporation
Effective date
2021-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:50

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose: Antibacterial

DOSAGE & ADMINISTRATION SECTION

Direction

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse

WARNINGS SECTION

Warning

For external use only - Hands only

OTC - STOP USE SECTION

Stop use and ask a doctor

  • if irritation or redness develops
  • condition persists for more than 72 hours.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes.
  •  If contact occurs, rinse eye thoroughly with water

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 right away

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Sodium Lauroamphoacetate , Polyquatemium-7, Citric Acid, Glycerin,

Aloe Barbadensis leaf Extract , Fragrance, Teocopheryl Acetate, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 40(Cl 16035)

INDICATIONS & USAGE SECTION

Uses for handwashing or decrease bacteria to the skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aloe_2aloe_2\ AloeAloe

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
50157-423-102025-01-30C16284748780-12cef2736-a2ab-d83d-e063-dadaa90ab31fKissable Refreshing Aloe - Hand Soap Antibacterial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-423-10Antibacterial1000 mL in 1 BOTTLE, PLASTICLIQUID10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-423ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]2Legacy NDC, 1 package rows20210310_bcfc5d73-368d-411c-e053-2a95a90ac862.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
50157-42350157-423-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAUROAMPHOACETATESLK428451LIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
GLYCOL DISTEARATE13W7MDN21WIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C RED NO. 4X3W0AM1JLXIACT
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
bd11c4db-176a-2979-e053-2a95a90aaee6bcfc5d73-368d-411c-e053-2a95a90ac8622021-03-08WarningsExact identifier
spl id: bd11c4db-176a-2979-e053-2a95a90aaee6
spl set id: bcfc5d73-368d-411c-e053-2a95a90ac862

Reported adverse events (FAERS/openFDA)#

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