FDA.reportPublic FDA data

High Five Antibacterial Hand

Manufacturer
Janisource, LLC
Effective date
2025-06-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:36:45

Label at a glance#

ProductHigh Five Antibacterial Hand
Active ingredientCHLOROXYLENOL
Label structure9 sections

Indications and uses

• Handwash to help decrease bacteria on the skin.

Dosage and administration

• Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly. • Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

• Handwash to help decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.
Do not use in the eyes. In case of contact, immediately flush eyes with water.

OTC - ASK DOCTOR 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply a small amount of product to wet hands, work into lather for 30 seconds, and rinse thoroughly.
• Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua) (7732-18-5), Sodium C14-16 Olefin Sulfonate (68439-57-6), Cocamidopropyl Hydroxysultaine (68139-30-0), Sodium Chloride (7647-14-5), Propanediol (26264-14-2), Propylene Glycol (57-55-6), Sodium Polyitaconate (26099-89-8), Fragrance (Proprietary), 2-Bromo-2-Nitropropane-1,3-Diol (52-51-7), Methylisothiazolinone (2682-20-4), Methylchloroisothiazolinone (26172-55-4), Dibromocyanoacetamide (10222-01-2), Yellow 5 (1934-21-0), Red 40 (25956-17-6).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49557-70149557-701-41

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
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
PROPANEDIOL5965N8W85TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM CHLORIDE451W47IQ8XIACT
EUGENOL3T8H1794QWIACT
CINNAMALDEHYDESR60A3XG0FIACT
CHLOROXYLENOL0F32U78V2QACTIB
WATER059QF0KO0RIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
FD&C RED NO. 40WZB9127XOAIACT
BRONOPOL6PU1E16C9WIACT
SODIUM POLYITACONATE (2800 MW, PHOSPHATE TERMINATED)G7SW5QN7TTIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
DIBROMOCYANOACETAMIDE7N51QGL6MJIACT

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
380486f9-ae52-95de-e063-6294a90a091cf665a352-775d-ebcc-e053-2a95a90ae3622025-06-20WarningsExact identifier
spl id: 380486f9-ae52-95de-e063-6294a90a091c
spl set id: f665a352-775d-ebcc-e053-2a95a90ae362

Reported adverse events (FAERS/openFDA)#

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