Alcohol Antiseptic 80% Topical Solution

Manufacturer
Wiley Organics, Inc.
Effective date
2020-03-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:04:16

Label at a glance#

ProductSanitizing Liquid for Community Support
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Surpervise 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 80%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age.
  • on open skin wounds.

Stop use Section

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of each of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Surpervise children under 6 years of age when using this product to avoid swallowing.

Oter Information

OTHER SAFETY INFORMATION

Store between 15-30 C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 74145-001-01 80AlcoholLabel80AlcoholLabel

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74145-001-012021-07-23C16284748780-1c7ccaba7-15b4-fd44-e053-dadaa90aa01bAlcohol Antiseptic 80% Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74145-001-01Sanitizing Liquid for Community Support950 mL in 1 BOTTLELIQUID9501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74145-001SANITIZING LIQUID FOR COMMUNITY SUPPORT (ALCOHOL HAND SANITIZER) LIQUID [WILEY ORGANICS, INC.]1Legacy NDC, 1 package rows20200330_a187f4ba-337e-8f97-e053-2a95a90ad142.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
74145-00174145-001-01

Ingredients#

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

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

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
a187f4ba-337f-8f97-e053-2a95a90ad142a187f4ba-337e-8f97-e053-2a95a90ad1422020-03-23WarningsExact identifier
spl id: a187f4ba-337f-8f97-e053-2a95a90ad142
spl set id: a187f4ba-337e-8f97-e053-2a95a90ad142

Reported adverse events (FAERS/openFDA)#

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