FDA.reportPublic FDA data

Medicated Lotion Skin Cleanser

Manufacturer
Betco Corporation, Ltd.
Effective date
2020-07-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:21:15

Label at a glance#

ProductSkin Cleanser
Active ingredientCHLOROXYLENOL
Label structure8 sections

Label contents#

Full prescribing information#

Medicated Lotion Skin Cleanser

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredient

​ ​Chloroxylenol 0.5%

Knuckle Under Medicated

INDICATIONS & USAGE SECTION

Uses

  • ​​For use in a variety of industrial setting including manufacturing, machine shops, maintenance areas and automotive shops.

Knuckle Under Medicated

WARNINGS SECTION

Warnings

  • For external use only.
  • Avoid contact with eyes.
  • If contact occurs, rinse thoroughly with water.
  • Discontinue use is irritation or redness develops.
  • If irritation persists for more than 72 hours, consult a physician.
  • KEEP OUT OF REACH OF CHILDREN.
  • If swallowed, get medical help or contact a poison control center right away.

Knuckle Under Medicated

DOSAGE & ADMINISTRATION SECTION

Directions

  • ​Read the entire label before using this product.
  • ​Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands..
  • Rinse with clean water.

Knuckle Under Medicated

INACTIVE INGREDIENT SECTION

Inactive Ingredients

​Water, sodium tallate, Sodium Laureth Sulfate, Triisopropanolamine, Alcohol, Tetrasodium EDTA, Sodium Chloride, Coco MIPA, Fragrance,  Cocamidopropropyl Betaine, Glycerin, Methyl Chlorosiothiazolinone, D&C Green #5, FD&C Yellow #5.

Knuckle Under Medicated

OTC - PURPOSE SECTION

Purpose

Antibacterial

Knuckle Under Medicated

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Medicated Lotion Skin Cleanser

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-1label-1

label-2label-2

label-3label-3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65601-865-042024-01-30C16284748780-11030e365-0517-111a-e063-dadaa90a10e2Medicated Lotion Skin Cleanser
65601-865-062024-01-30C16284748780-11030e365-0517-111a-e063-dadaa90a10e2Medicated Lotion Skin Cleanser
65601-865-552024-01-30C16284748780-11030e365-0517-111a-e063-dadaa90a10e2Medicated Lotion Skin Cleanser

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65601-86565601-865-04, 65601-865-06, 65601-865-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ALUMINIUM SILICATE058TS43PSMIACT
SODIUM HYDROXIDE55X04QC32IIACT
TRISODIUM NITRILOTRIACETATEE3C8R2M0XDIACT
METHYL ALCOHOLY4S76JWI15IACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
EDETATE SODIUMMP1J8420LUIACT
TALL OIL ACIDH9HR63474MIACT
ALCOHOL3K9958V90MIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
SODIUM CHLORIDE451W47IQ8XIACT
D&C GREEN NO. 58J6RDU8L9XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DIISOPROPANOLAMINE0W44HYL8T5IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
CALCIUM SILICATES4255P4G5MIACT
FORMALDEHYDE1HG84L3525IACT
DIOXANEJ8A3S10O7SIACT
SODIUM FERROCYANIDE5HT6X21AIDIACT
SODIUM CARBONATE45P3261C7TIACT
SODIUM GLYCOLATEB75E535IMIIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT

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
1c59a802-cc45-0473-e063-6294a90a7a84aa913134-c6a0-2920-e053-2a95a90a3be22024-07-03WarningsExact identifier
spl set id: aa913134-c6a0-2920-e053-2a95a90a3be2

Reported adverse events (FAERS/openFDA)#

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