FDA.reportPublic FDA data

KLENLII HAND SANII ALCOHOL SANITIZER

Manufacturer
Klenlii Company
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:12:21

Label at a glance#

ProductKLENLII HAND SANII ALCOHOL SANITIZER
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

DECREASE BACTERIA ON SKIN THAT COULD CAUSE DISEASE RECOMMENDED FOR REPEATED USE

Dosage and administration

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING NOT FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION NOT RECOMMENDED FOR INFANTS

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHYL ALCOHOL 62%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

  • DECREASE BACTERIA ON SKIN THAT COULD CAUSE DISEASE
  • RECOMMENDED FOR REPEATED USE

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY: HANDS

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

WHEN USING THIS PRODUCT

  • KEEP OUT OF EYES
  • IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER
  • AVOID CONTACT WITH BROKEN SKIN
  • DO NOT INHALE OR DIGEST

STOP USE AND ASK DOCTOR IF

  • IRRITATION OR REDNESS DEVELOPS
  • CONDITION PERSISTS 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.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING
  • NOT FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION
  • NOT RECOMMENDED FOR INFANTS

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

DEIONIZED WATER, CARBOPOL, GLYCERIN, FRAGRANCE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Klenlii Hand Sanii Gel_8oz01b LBL_Klenlii Hand Sanii Gel_8oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78016-102-112026-01-29C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-122026-01-29C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-142026-01-29C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-162026-01-29C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-182026-01-29C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-112024-05-09C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-122024-05-09C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-142024-05-09C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-162024-05-09C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-182024-05-09C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-112024-01-30C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-122024-01-30C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-142024-01-30C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-162024-01-30C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)
78016-102-182024-01-30C16284748780-11030e365-6666-111a-e063-dadaa90a10e2KLENLII HAND SANII ALCOHOL SANITIZERGEL (62% ETHYL ALCOHOL) (78016-102)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78016-102-11KLENLII HAND SANII ALCOHOL SANITIZER3785 mL in 1 JUGGEL37855
78016-102-12KLENLII HAND SANII ALCOHOL SANITIZER59 mL in 1 BOTTLEGEL595
78016-102-14KLENLII HAND SANII ALCOHOL SANITIZER118 mL in 1 BOTTLEGEL1185
78016-102-16KLENLII HAND SANII ALCOHOL SANITIZER476 mL in 1 BOTTLEGEL4765
78016-102-18KLENLII HAND SANII ALCOHOL SANITIZER237 mL in 1 BOTTLEGEL2375

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78016-102KLENLII HAND SANII ALCOHOL SANITIZER (ETHYL ALCOHOL) GEL [KLENLII COMPANY]5Legacy NDC, 5 package rows20240511_8af5941e-68ac-4b3e-a25d-530904c204de.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
78016-10278016-102-18, 78016-102-14, 78016-102-16, 78016-102-11, 78016-102-12

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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB

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
180c722b-b18d-49c5-e063-6394a90a7bfe8af5941e-68ac-4b3e-a25d-530904c204de2024-05-09WarningsExact identifier
spl id: 180c722b-b18d-49c5-e063-6394a90a7bfe
spl set id: 8af5941e-68ac-4b3e-a25d-530904c204de

Reported adverse events (FAERS/openFDA)#

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