FDA.reportPublic FDA data

Alcohol Antiseptic 80% Topical Solution

Manufacturer
Resource One Inc
Effective date
2020-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:11:02

Label at a glance#

ProductAlcohol Antiseptic 80
Active ingredientALCOHOL
Label structure6 sections

Dosage and administration

Place enough product on hands to cover all surfaces. 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

Alcohol 80% v/v

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Use(s):

INDICATIONS & USAGE SECTION

Hand sanitizer to help reduce the bacteria that potentially will cause disease

Warnings:

WARNINGS SECTION

For External Use Only
Flammable keep away from children

When using this product:

OTC - WHEN USING SECTION

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop and ask a doctor if:

OTC - STOP USE SECTION

If irration or rash occurs. These may be signs of a serious condition.

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Glycerin, Hydrogen peroxide, purified water USP

Packaeg Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
77188-000-012023-01-30C16284748780-1f386c649-f451-0266-e053-dadaa90a7c1aAlcohol Antiseptic 80% Topical Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77188-000-01Alcohol Antiseptic 803785 mL in 1 BOTTLELIQUID37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77188-000ALCOHOL ANTISEPTIC 80 (ALCOHOL) LIQUID [RESOURCE ONE INC]1Legacy NDC, 1 package rows20200513_a574e835-6609-10ab-e053-2a95a90a825c.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
77188-00077188-000-01

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
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a574d424-7883-81c0-e053-2995a90ad842a574e835-6609-10ab-e053-2a95a90a825c2020-05-12WarningsExact identifier
spl id: a574d424-7883-81c0-e053-2995a90ad842
spl set id: a574e835-6609-10ab-e053-2a95a90a825c

Reported adverse events (FAERS/openFDA)#

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