FDA.reportPublic FDA data

Antibacterial Hand

Manufacturer
US Chemical Corporation | Kutol Products Company
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:26:56

Label at a glance#

ProductAntibacterial Hand
Active ingredientCHLOROXYLENOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse. Children under 6 years of age should be supervised when using this product.

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Tall Oil Acide, Potassium Hydroxide, Coconut Acid, Phenoxyethanol, Cocamide DIPA, Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Tetrasodium EDTA, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Sodium Sulfate, Iodopropynl, Butylcarbamate, Yellow 5, Red 33.

INDICATIONS & USAGE SECTION

Uses Handwash to help decrease bacteria on the skin.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Chloroxylenol 0.3% w/w

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.

OTC - PURPOSE SECTION

Purpose Antibacterial Agent

WARNINGS SECTION

Warnings For external use only. Avoid contact with eyes. In case of contact, flush with plenty of water. Stop use, and ask a doctor if irritation or rash appears and persists.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal LabelPrincipal Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61307-060-092022-01-31C16284748780-1d6a99b39-d565-a426-e053-dadaa90af4c2US Chem F060
61307-060-092022-01-28C16284748780-1d6a99b39-d565-a426-e053-dadaa90af4c2US Chem F060

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
61307-06061307-060-09

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
TALL OIL ACIDH9HR63474MIACT
COCONUT ACID40U37V505DIACT
ACID RED 3502BXM5Q7GEIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CHLOROXYLENOL0F32U78V2QACTIB
WATER059QF0KO0RIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
SODIUM LAURETH-12 SULFATE8M492LDU23IACT
SODIUM LAURYL SULFATE368GB5141JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
SODIUM SULFATE0YPR65R21JIACT
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATEQI9A6U005WIACT
ALOE VERA LEAFZY81Z83H0XIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

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
03a8bd37-d223-2a2d-e063-6294a90a0406a18a50c0-49d2-1a96-e053-2995a90a29b52023-08-24WarningsExact identifier
spl id: 03a8bd37-d223-2a2d-e063-6294a90a0406
spl set id: a18a50c0-49d2-1a96-e053-2995a90a29b5

Reported adverse events (FAERS/openFDA)#

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