FDA.reportPublic FDA data

LK New Antiseptic Ethanol

Manufacturer
Venice Cosmetic
Effective date
2020-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:09:09

Label at a glance#

ProductLK New Antiseptic Ethanol
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Take appropriate amount onto your hand and spread it all the way to fingertips. Rub hands together until dry. Supervise Children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol 83%

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

OTC - PURPOSE SECTION

Antibacterial

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

if you are allergic to any of the ingredients
in children less than 2 months of age
on open skin wounds

When using this product avoid contact with eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take appropriate amount onto your hand and spread it all the way to fingertips. Rub hands together until dry.
  • Supervise Children under 6 years of age when using this product to avoid swallowing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water

Keep out of reach of children

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 (1-800-222-1222) right away.

LK New Antiseptic Ethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

74488-01174488-01174488-01074488-010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287156ethanol 83 % Topical SolutionPSN1
2287156ethanol 0.83 ML/ML Topical SolutionSCD1
2287156ethyl alcohol 83 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74488-010-012022-01-28C16284748780-1d6a99b39-3c3a-a426-e053-dadaa90af4c2LK New Antiseptic Ethanol
74488-011-012022-01-28C16284748780-1d6a99b39-3c3a-a426-e053-dadaa90af4c2LK New Antiseptic Ethanol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74488-010-01LK New Antiseptic Ethanol100 mL in 1 BOTTLELIQUID1001
74488-011-01LK New Antiseptic Ethanol255 mL in 1 BOTTLELIQUID2551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74488-010LK NEW ANTISEPTIC ETHANOL (ALCOHOL) LIQUID [VENICE COSMETIC]1Legacy NDC, 1 package rows20200501_a480bd8a-1d09-276c-e053-2a95a90ac774.zip
74488-011LK NEW ANTISEPTIC ETHANOL (ALCOHOL) LIQUID [VENICE COSMETIC]1Legacy NDC, 1 package rows20200501_a480bd8a-1d09-276c-e053-2a95a90ac774.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74488-01074488-010-01
74488-01174488-011-01

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
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
a480bd8a-1d0a-276c-e053-2a95a90ac774a480bd8a-1d09-276c-e053-2a95a90ac7742020-04-30WarningsExact identifier
spl id: a480bd8a-1d0a-276c-e053-2a95a90ac774
spl set id: a480bd8a-1d09-276c-e053-2a95a90ac774

Reported adverse events (FAERS/openFDA)#

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