FDA.reportPublic FDA data

ETHYL ALCOHOL 80 PERCENT

Manufacturer
CLUB CARIBE
Effective date
2020-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:08

Label at a glance#

ProductETHYL ALCOHOL 80 PERCENT
Active ingredientALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION - ETHYL ALCOHOL 80% ANTISEPTIC

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMIN ETHYL ALCOHOL 80DOSAGE & ADMIN ETHYL ALCOHOL 80

WARNINGS - ETHYL ALCOHOL 80% ANTISEPTIC

WARNINGS SECTION

WARNINGS ETHYL ALCOHOL 80WARNINGS ETHYL ALCOHOL 80

INACTIVE INGREDIENTS - ETHYL ALCOHOL 80% ANTISEPTIC

INACTIVE INGREDIENT SECTION

INACTIE INGREDIENTS ETHYL ALCOHOL 80INACTIE INGREDIENTS ETHYL ALCOHOL 80

INDICATION & USAGE - ETHYL ALCOHOL 80% ANTISEPTIC

INDICATIONS & USAGE SECTION

INDICATION & USAGE ETHYL ALCOHOL 80INDICATION & USAGE ETHYL ALCOHOL 80

KEEP OUT REACH CHILDREN - ETHYL ALCOHOL 80% ANTISEPTIC

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT REACH CHILDREN ETHYL ALCOHOL 80KEEP OUT REACH CHILDREN ETHYL ALCOHOL 80

PURPOSE - ETHYL ALCOHOL 80% ANTISEPTIC

OTC - PURPOSE SECTION

PURPOSE - ETHYL ALCOHOL 80PURPOSE - ETHYL ALCOHOL 80

ACTIVE INGREDIENT - ETHYL ALCOHOL 80% ANTISEPTIC

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT - ETHYL ALCOHOL 80ACTIVE INGREDIENT - ETHYL ALCOHOL 80

ETHYL ALCOHOL 80 PERCENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

750 mL ETHYL ALCOHOL 80%750 mL ETHYL ALCOHOL 80%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74336-800-012022-01-28C16284748780-1d6a99b39-4182-a426-e053-dadaa90af4c2ETHYL ALCOHOL 80 PERCENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74336-800-01ETHYL ALCOHOL 80 PERCENT750 mL in 1 BOTTLELIQUID7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74336-800ETHYL ALCOHOL 80 PERCENT (ETHYL ALCOHOL) LIQUID [CLUB CARIBE]1Legacy NDC, 1 package rows20200626_a8ed7e57-6bde-e82a-e053-2995a90a7918.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74336-80074336-800-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT

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
a8ed7e57-6bdf-e82a-e053-2995a90a7918a8ed7e57-6bde-e82a-e053-2995a90a79182020-06-25WarningsExact identifier
spl id: a8ed7e57-6bdf-e82a-e053-2995a90a7918
spl set id: a8ed7e57-6bde-e82a-e053-2995a90a7918

Reported adverse events (FAERS/openFDA)#

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