FDA.reportPublic FDA data

Klean-Hands

Manufacturer
Rite-Kem Incorporated
Effective date
2021-03-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:38:59

Label at a glance#

ProductKlean-Hands
Active ingredientCHLOROXYLENOL
Label structure11 sections

Label contents#

Full prescribing information#

COMPONENTS

Chloroxylenol 0.3%

OTC - PURPOSE SECTION

Antimicrobial Hand Soap

INDICATIONS & USAGE SECTION

Handwash to help decrease bacteria on the skin. Recommended for repeated use

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts

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.

DOSAGE & ADMINISTRATION SECTION

Wet hands
Apply a small amount of product and work into a lather
Rinse well and dry hands completely

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3%

INACTIVE INGREDIENT SECTION

Dodecylbenzene sulfonic acid, triethanolamine salt, Cocoamidopropyl betaine, Glycerol, 1,3-propanediol, Ammonium lauryl sulfate, Coconut monoethanolamide, Sodium Chloride, Fragrance, Dye, Water

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Klean-Hands Antimicrobial Hand soap

Formulated for food service and health care professionals who wash hands frequently and require the protection of an antimicrobial soap.

FDA registered

Made in USA

* Utilize the quickacting antimicrobial agent (PCMX) to kill germs

* Pleasing agent

* Powerful degreasers

* Soothing to the skin

* Ideal schools, health clubs, offices and recreation areas

* Rich Lather

* High foam enhances cleaning

* Performs equally well in hand and soft water

* Conditions as it cleans

Sold by: Rite-Kem Inc., 703 Westmoreland Drive, Tupelco, MS 38801

Ph.: 662-840-6060

NDC: 73943-948-xx

Klean Hands 55GKlean Hands 55G

Klean Hands 5GKlean Hands 5G

Klean HandsKlean Hands

Klean Hands 128ozKlean Hands 128oz

Klean Hands 8ozKlean Hands 8oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413261chloroxylenol 0.3 % Medicated Liquid SoapPSN3
413261chloroxylenol 3 MG/ML Medicated Liquid SoapSCD3
413261chloroxylenol 0.3 % Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73943-948-012023-01-30C16284748780-1f386c64a-1731-0266-e053-dadaa90a7c1aAntimicrobial Hand Soap
73943-948-022023-01-30C16284748780-1f386c64a-1731-0266-e053-dadaa90a7c1aAntimicrobial Hand Soap
73943-948-032023-01-30C16284748780-1f386c64a-1731-0266-e053-dadaa90a7c1aAntimicrobial Hand Soap
73943-948-042023-01-30C16284748780-1f386c64a-1731-0266-e053-dadaa90a7c1aAntimicrobial Hand Soap
73943-948-052023-01-30C16284748780-1f386c64a-1731-0266-e053-dadaa90a7c1aAntimicrobial Hand Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73943-948-01Klean-Hands354 mL in 1 BOTTLELIQUID3543
73943-948-02Klean-Hands3785 mL in 1 BOTTLELIQUID37853
73943-948-03Klean-Hands18927 mL in 1 BOTTLELIQUID189273
73943-948-04Klean-Hands208198 mL in 1 BOTTLELIQUID2081983
73943-948-05Klean-Hands236 mL in 1 BOTTLELIQUID2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73943-948KLEAN-HANDS LIQUID [RITE-KEM INCORPORATED]3Legacy NDC, 5 package rows20210316_af99febf-b537-3038-e053-2a95a90a641d.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73943-94873943-948-01, 73943-948-02, 73943-948-03, 73943-948-04, 73943-948-05

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
TROLAMINE9O3K93S3TKIACT
CHLOROXYLENOL0F32U78V2QACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCO MONOETHANOLAMIDEC80684146DIACT
LAVENDER OILZBP1YXW0H8IACT
PROPANEDIOL5965N8W85TIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
DODECYLBENZENESULFONIC ACID60NSK897G9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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
bd887255-90ec-7fe4-e053-2995a90a38a6af99febf-b537-3038-e053-2a95a90a641d2021-03-14WarningsExact identifier
spl id: bd887255-90ec-7fe4-e053-2995a90a38a6
spl set id: af99febf-b537-3038-e053-2a95a90a641d

Reported adverse events (FAERS/openFDA)#

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