FDA.reportPublic FDA data

KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT

Manufacturer
CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY
Effective date
2020-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:05:56

Label at a glance#

ProductKLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT
Active ingredientALCOHOL
Label structure10 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Ethanol 65%

OTC - PURPOSE SECTION

Purpose

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

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

When using this product 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 40°C (104°F) • tamper evident

INACTIVE INGREDIENT SECTION

Inactive ingredients water, extra virgin coconut oil, xanthan gum, glycerin, nipagin, nipasol, EDTA-4Na, tea tree essential oil

OTC - QUESTIONS SECTION

Questions? +1-800-674-3263

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM

SPL UNCLASSIFIED SECTION

KLEANER For A Healthier Life

ANTIBACTERIAL

TEA TREE SCENT

hand crafted in small batches designed for daily use 

Distributed by:

Chiavaye LLC

Denver, CO 80209

kleanhandsanitizer.com

Customer Service:

support@kleanhandsanitizer.com

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

Made in Vietnam

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Klean1Klean1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN1
902574ethanol 0.65 ML/ML Topical GelSCD1
902574ethyl alcohol 65 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74025-444-902021-07-23C16284748780-1c7ccaba7-16aa-fd44-e053-dadaa90aa01bKLEAN + TM INSTANT HAND SANITIZER TEA TREE SCENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74025-444-90KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT90 mL in 1 BOTTLE, PLASTICGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74025-444KLEAN PLUS INSTANT HAND SANITIZER TEA TREE SCENT (ETHANOL) GEL [CATCHERS INTERNATIONAL LIMITED LIABILITY COMPANY]1Legacy NDC, 1 package rows20200412_96515326-b808-4b83-b922-7696b00669c1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74025-44474025-444-90

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
COCONUT OILQ9L0O73W7LIACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE SODIUMMP1J8420LUIACT
TEA TREE OILVIF565UC2GIACT

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
d890e0f6-7fd8-4b73-84cf-94b05f6fc3bc96515326-b808-4b83-b922-7696b00669c12020-04-07WarningsExact identifier
spl id: d890e0f6-7fd8-4b73-84cf-94b05f6fc3bc
spl set id: 96515326-b808-4b83-b922-7696b00669c1

Reported adverse events (FAERS/openFDA)#

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