FDA.reportPublic FDA data

Isopropyl Alcohol Antiseptic 75% Topical Solution Antiseptic Hand Rub

Manufacturer
Aurohealth LLC | Aurolife Pharma LLC
Effective date
2020-06-25
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 23:20:54

Label at a glance#

ProductIsopropyl Alcohol Antiseptic 75%
Active ingredientISOPROPYL ALCOHOL
Label structure13 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.

Storage and handling

Store between 15-30 0 C (59-86 0 F) Avoid freezing and excessive heat about 40 0 C (104 0 F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 75% v/v

PURPOSE

OTC - PURPOSE SECTION

Antiseptic

USE(S)

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

WARNINGS

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

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

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

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation 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

Keep out of reach 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.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • Store between 15-300C (59-860F)
  • Avoid freezing and excessive heat about 400C (1040F)

INACTIVE INGREDIENT SECTION

Glycerin, hydrogen peroxide, purified water USP

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

1-855-274-422

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-005-38
Isopropyl Alcohol Antiseptic 75%
Topical Solution
Antiseptic Hand Rub
Non-sterile Solution
128 OZ (3785mL)


isopropyl
isopropyl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD1
1039900isopropyl alcohol 75 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58602-005-382023-01-30C16284748780-1f386c649-e248-0266-e053-dadaa90a7c1aIsopropyl Alcohol Antiseptic 75% Topical Solution Antiseptic Hand Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-005-38Isopropyl Alcohol Antiseptic 75%3785 mL in 1 BOTTLESOLUTION37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-005ISOPROPYL ALCOHOL ANTISEPTIC 75% (ISOPROPYL ALCOHOL ANTISEPTIC 75 %) SOLUTION [AUROHEALTH LLC]1Legacy NDC, 1 package rows20200711_0a5b9e3c-a23a-4556-b136-ff978de9ac90.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
58602-00558602-005-38

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
ISOPROPYL ALCOHOLND2M416302ACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
0a5b9e3c-a23a-4556-b136-ff978de9ac900a5b9e3c-a23a-4556-b136-ff978de9ac902020-06-25WarningsExact identifier
spl id: 0a5b9e3c-a23a-4556-b136-ff978de9ac90
spl set id: 0a5b9e3c-a23a-4556-b136-ff978de9ac90

Reported adverse events (FAERS/openFDA)#

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