FDA.reportPublic FDA data

Klean Antiseptic Hand Sanitizer

Manufacturer
CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY
Effective date
2020-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:28

Label at a glance#

ProductKlean Antiseptic Hand Sanitizer
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

Other information   •  store between 15-30°C (59-86°F)   •  avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 67%

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses  •  hand sanitizer to decrease bacteria on the skin  •  recommended for repeated use  •  for use when soap and water are not available

WARNINGS SECTION

Warnings

• Flammable, keep away from fire/flame

• For external use only

Do not use  •  in children less than 2 months of age  •  on open skin wounds

When using this product  •  do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if  •  irritation and redness develop  •  condition persists for more than 72 hours

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

Directions • wet hands thoroughly with product and allow to dry without wiping  •  supervise children under 6 years of age when using this product to avoid swallowing

STORAGE AND HANDLING SECTION

Other information   •  store between 15-30°C (59-86°F)   •  avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT SECTION

Inactive ingredients  didecyldimethylammonium chloride, eucalyptus oil, lavender oil, rosemary oil, water

OTC - QUESTIONS SECTION

Questions? +1-800-674-3263

You may also report serious effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

GUARANTEED NATURAL & PURE

CRISP LAVENDER

KLEANER

For A Healthier Life

67% Ethyl Alcohol

Hand Crafted In Small Batches Designed for Daily Use

Manufactured for: Klean + Hand Sanitizer, PO Box 9751, 225 S Broadway, Denver, CO 80209

Made in Vietnam

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1997446ethanol 67 % Topical SprayPSN1
1997446ethanol 0.67 ML/ML Topical SpraySCD1
1997446ethanol 67 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74025-777-502021-07-23C16284748780-1c7ccaba7-0f57-fd44-e053-dadaa90aa01bKlean + Antiseptic Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74025-777-50Klean Antiseptic Hand Sanitizer50 mL in 1 BOTTLE, SPRAYSPRAY501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74025-777KLEAN ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) SPRAY [CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY]1Legacy NDC, 1 package rows20200401_3488af1c-8525-4332-9686-cbe8c744b73d.zip

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
74025-77774025-777-50

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
ALCOHOL3K9958V90MACTIB
DIDECYLDIMONIUM CHLORIDEJXN40O9Y9BIACT
EUCALYPTUS OIL2R04ONI662IACT
LAVENDER OILZBP1YXW0H8IACT
ROSEMARY OIL8LGU7VM393IACT
WATER059QF0KO0RIACT

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
ca91ffb1-f6f0-4ff9-9046-1f2fba8a423e3488af1c-8525-4332-9686-cbe8c744b73d2020-03-28WarningsExact identifier
spl id: ca91ffb1-f6f0-4ff9-9046-1f2fba8a423e
spl set id: 3488af1c-8525-4332-9686-cbe8c744b73d

Reported adverse events (FAERS/openFDA)#

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