FDA.reportPublic FDA data

Butler Clean Hands

Manufacturer
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.
Effective date
2020-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:46:51

Label at a glance#

ProductButler Clean Hands
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

For hand washing to decrease bacteria on the skin.

Dosage and administration

-Apply to wet hands. -Work into a lather 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

Benzalkonium Chloride.......0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin.

Warnings

WARNINGS SECTION

For external use only.

When Using this Product

GENERAL PRECAUTIONS SECTION

Avoid contact with the eyes.

In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops

and conditions persist.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help

or contact a Posion Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

-Apply to wet hands.

-Work into a lather and rinse thoroughly.

-Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Yellow #5, Red #40

Butler Clean Hands

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Butler Clean Handsimage descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50241-31850241-318-01, 50241-318-02

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
Water059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
CAPRYLYL GLUCOSIDEV109WUT6RLIACT
GLYCERINPDC6A3C0OXIACT

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
aa751088-30b8-a713-e053-2a95a90a318e14068c19-47cb-4852-b006-3fdb222972b92020-07-15WarningsExact identifier
spl set id: 14068c19-47cb-4852-b006-3fdb222972b9

Reported adverse events (FAERS/openFDA)#

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