FDA.reportPublic FDA data

Isopropyl Alcohol Sanitizer

Manufacturer
safety wercs | WINNER MEDICAL（JIAYU）CO., LTD.
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:11

Label at a glance#

ProductIsopropyl Alcohol Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Indications and uses

All-purpose cleaner for multiple surfaces and objects.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol:70%(v/v)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

All-purpose cleaner for multiple surfaces and objects.

WARNINGS

WARNINGS SECTION

For external use only.

Flammable.

Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

On children less than 2 months of age

On open skin wounds

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 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

If swallowed, get medical help or contact a Poison Control Center right away.

Other Information

OTHER SAFETY INFORMATION

Store between 15-30°C (59-86°F)

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Deionized Water

Uses

DOSAGE & ADMINISTRATION SECTION

All-purpose cleaner for multiple surfaces and objects

NDC 84354-103-02 32FL.OZ(946 ML NET WT)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isopropyl Alcohol SanitizerIsopropyl Alcohol Sanitizer

NDC 84354-103-01 1 GALLON (128 FL.OZ.NET WT.)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Isopropyl Alcohol SanitizerIsopropyl Alcohol SanitizerIsopropyl Alcohol SanitizerIsopropyl Alcohol Sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
808520isopropyl alcohol 70 % Topical SolutionPSN1
808520isopropyl alcohol 0.7 ML/ML Topical SolutionSCD1
808520isopropyl alcohol 70 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84354-103-012026-01-29C16284748780-149896155-a23a-586f-e063-e6dba90add90Isopropyl Alcohol Sanitizer
84354-103-022026-01-29C16284748780-149896155-a23a-586f-e063-e6dba90add90Isopropyl Alcohol Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84354-103-01Isopropyl Alcohol Sanitizer3785 mL in 1 BOTTLESOLUTION37851
84354-103-02Isopropyl Alcohol Sanitizer946 mL in 1 BOTTLESOLUTION9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84354-103ISOPROPYL ALCOHOL SANITIZER SOLUTION [SAFETY WERCS]12 package rows20240627_1bc89b52-e143-1295-e063-6394a90a6aa5.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
84354-10384354-103-01, 84354-103-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
1bc8aaeb-5a3f-6f4f-e063-6294a90af7a81bc89b52-e143-1295-e063-6394a90a6aa52024-06-26WarningsExact identifier
spl id: 1bc8aaeb-5a3f-6f4f-e063-6294a90af7a8
spl set id: 1bc89b52-e143-1295-e063-6394a90a6aa5

Reported adverse events (FAERS/openFDA)#

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