FDA.reportPublic FDA data

KLENLII HAND SANII ALCOHOL SANITIZER

Manufacturer
Klenlii Company
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:23

Label at a glance#

ProductKLENLII HAND SANII ALCOHOL SANITIZER
Active ingredientALCOHOL, ISOPROPYL ALCOHOL
Label structure8 sections

Indications and uses

DECREASE BACTERIA ON SKIN

Dosage and administration

THOROUGHLY WET HANDS WITH PRODUCT AND ALLOW TO DRY

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 63%

ISOPROPYL ALCOHOL 7%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

  • DECREASE BACTERIA ON SKIN

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY: HANDS

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

  • KEEP OUT OF EYES

STOP USE AND ASK DOCTOR IF

  • IRRITATION OR REDNESS DEVELOPS

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

  • THOROUGHLY WET HANDS WITH PRODUCT AND ALLOW TO DRY

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

DEIONIZED WATER, GLYCERIN

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Klenlii_Hand Sanii Spray_2 FL oz01b LBL_Klenlii_Hand Sanii Spray_2 FL oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2397769ethanol 63 % / isopropyl alcohol 7 % Topical SprayPSN4
2397769ethanol 0.63 ML/ML / isopropyl alcohol 0.07 ML/ML Topical SpraySCD4
2397769ethanol 63 % / isopropyl alcohol 7 % Topical SpraySY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78016-107-112026-01-29C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-122026-01-29C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-142026-01-29C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-162026-01-29C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-182026-01-29C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-112024-05-11C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-122024-05-11C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-142024-05-11C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-162024-05-11C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-182024-05-11C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-112024-01-30C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-122024-01-30C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-142024-01-30C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-162024-01-30C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)
78016-107-182024-01-30C16284748780-11030e364-fe41-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZER SPRAY (63% ETHYL ALCOHOL, 7% IPA) (78016-107)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78016-107-11KLENLII HAND SANII ALCOHOL SANITIZER3785 mL in 1 JUGSPRAY37854
78016-107-12KLENLII HAND SANII ALCOHOL SANITIZER59 mL in 1 BOTTLESPRAY594
78016-107-14KLENLII HAND SANII ALCOHOL SANITIZER118 mL in 1 BOTTLESPRAY1184
78016-107-16KLENLII HAND SANII ALCOHOL SANITIZER476 mL in 1 BOTTLESPRAY4764
78016-107-18KLENLII HAND SANII ALCOHOL SANITIZER238 mL in 1 BOTTLESPRAY2384

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78016-107KLENLII HAND SANII ALCOHOL SANITIZER (ETHYL ALCOHOL, ISOPROPYL ALCOHOL) SPRAY [KLENLII COMPANY]4Legacy NDC, 5 package rows20240513_2be72fb4-1295-44dd-bf02-97a42b1db403.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78016-10778016-107-18, 78016-107-14, 78016-107-16, 78016-107-11, 78016-107-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB

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
180d214a-0da7-59b0-e063-6294a90a01502be72fb4-1295-44dd-bf02-97a42b1db4032024-05-09WarningsExact identifier
spl id: 180d214a-0da7-59b0-e063-6294a90a0150
spl set id: 2be72fb4-1295-44dd-bf02-97a42b1db403

Reported adverse events (FAERS/openFDA)#

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