FDA.reportPublic FDA data

KLENLII HAND

Manufacturer
Klenlii Company
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:21

Label at a glance#

ProductKLENLII HAND ANTIBACTERIAL
Active ingredientCHLOROXYLENOL
Label structure8 sections

Indications and uses

HANDWASH TO HELP DECREASE BACTERIA ON THE SKIN RECOMMENDED FOR REPEATED USE

Dosage and administration

WET HANDS APPLY A SMALL AMOUNT OF PRODUCT AND WORK INTO A LATHER RINSE WELL AND DRY HANDS COMPLETELY

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

CHLOROXYLENOL 0.3%

PURPOSE

OTC - PURPOSE SECTION

ANTIMICROBIAL

USES

INDICATIONS & USAGE SECTION

  • HANDWASH TO HELP DECREASE BACTERIA ON THE SKIN
  • RECOMMENDED FOR REPEATED USE

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY: HANDS

WHEN USING THIS PRODUCT

  • KEEP OUT OF AND AWAY FROM EYES
  • IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER
  • DO NOT INHALE OR INGEST

STOP USE AND ASK DOCTOR IF

  • IRRITATION OR REDNESS DEVELOPS
  • CONDITION PERSISTS

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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • WET HANDS
  • APPLY A SMALL AMOUNT OF PRODUCT AND WORK INTO A LATHER
  • RINSE WELL AND DRY HANDS COMPLETELY

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

DEIONIZED WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, AQUEOUS CATONIC COPOLYMER, CITRIC ACID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Klenlii_Hand Sanii Soap_8oz01b LBL_Klenlii_Hand Sanii Soap_8oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN4
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD4
413261chloroxylenol 0.3 % Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78016-106-112026-01-29C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-122026-01-29C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-142026-01-29C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-162026-01-29C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-182026-01-29C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-112024-05-09C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-122024-05-09C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-142024-05-09C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-162024-05-09C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-182024-05-09C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-112024-01-30C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-122024-01-30C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-142024-01-30C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-162024-01-30C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)
78016-106-182024-01-30C16284748780-11030e365-50a0-111a-e063-dadaa90a10e2KLENLII HAND SOAP ANTIBACTERIAL (78016-106)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78016-106-11KLENLII HANDANTIBACTERIAL3785 mL in 1 JUGSOAP37854
78016-106-12KLENLII HANDANTIBACTERIAL59 mL in 1 BOTTLESOAP594
78016-106-14KLENLII HANDANTIBACTERIAL118 mL in 1 BOTTLESOAP1184
78016-106-16KLENLII HANDANTIBACTERIAL476 mL in 1 BOTTLESOAP4764
78016-106-18KLENLII HANDANTIBACTERIAL238 mL in 1 BOTTLESOAP2384

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78016-106KLENLII HAND ANTIBACTERIAL (CHLOROXYLENOL) SOAP [KLENLII COMPANY]4Legacy NDC, 5 package rows20240511_bb5f6bb3-c20c-4326-9b8d-ac7f7d2f4274.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78016-10678016-106-18, 78016-106-14, 78016-106-16, 78016-106-11, 78016-106-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CHLOROXYLENOL0F32U78V2QACTIB

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
180c6cf8-ac82-50c0-e063-6294a90ae391bb5f6bb3-c20c-4326-9b8d-ac7f7d2f42742024-05-09WarningsExact identifier
spl id: 180c6cf8-ac82-50c0-e063-6294a90ae391
spl set id: bb5f6bb3-c20c-4326-9b8d-ac7f7d2f4274

Reported adverse events (FAERS/openFDA)#

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