FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
Marine Essence Biosciences Corporation of USA
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:16:03

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure15 sections

Label contents#

Full prescribing information#

Active Ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 75% v/v ……………………………………..………………………………………………………………………...Antiseptic

OTC - PURPOSE SECTION

Hand sanitizer to help reduce bacteria that potentially can cause disease.

OTC - DO NOT USE SECTION

In children less than 2 months of age

On open skin wounds

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.

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

INSTRUCTIONS FOR USE SECTION

Directions

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 SAFETY INFORMATION

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

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

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, carbomer 940, triethanolamine, purified water USP

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

Topical - Administration to a particular spot on the outer surface of the body.

DOSAGE FORMS & STRENGTHS SECTION

Gel form

INDICATIONS & USAGE SECTION

To help reduce bacteria on the hands that can potentially cause disease.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ME-Bio Isopropyl AlcoholME-Bio Isopropyl Alcohol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN3
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD3
2285607isopropyl alcohol 75 % Topical GelSY3

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
73764-001-012021-07-23C16284748780-1c7ccaba7-1b72-fd44-e053-dadaa90aa01bIsopropyl Alcohol Hand Sanitizer
73764-001-022021-07-23C16284748780-1c7ccaba7-1b72-fd44-e053-dadaa90aa01bIsopropyl Alcohol Hand Sanitizer
73764-001-032021-07-23C16284748780-1c7ccaba7-1b72-fd44-e053-dadaa90aa01bIsopropyl Alcohol Hand Sanitizer
73764-001-042021-07-23C16284748780-1c7ccaba7-1b72-fd44-e053-dadaa90aa01bIsopropyl Alcohol Hand Sanitizer
73764-001-052021-07-23C16284748780-1c7ccaba7-1b72-fd44-e053-dadaa90aa01bIsopropyl Alcohol Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73764-001-01Isopropyl Alcohol500 mL in 1 BOTTLE, PUMPGEL5003
73764-001-02Isopropyl Alcohol236 mL in 1 BOTTLE, PUMPGEL2363
73764-001-03Isopropyl Alcohol177 mL in 1 BOTTLE, PUMPGEL1773
73764-001-04Isopropyl Alcohol473 mL in 1 BOTTLE, PUMPGEL4733
73764-001-05Isopropyl Alcohol250 mL in 1 BOTTLE, PUMPGEL2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73764-001ISOPROPYL ALCOHOL GEL [MARINE ESSENCE BIOSCIENCES CORPORATION OF USA]3Legacy NDC, 5 package rows20200605_a1ba4e03-1c3d-e7f9-e053-2995a90a07b9.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
73764-00173764-001-01, 73764-001-02, 73764-001-03, 73764-001-04, 73764-001-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE9O3K93S3TKIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
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
a736838b-b55c-f066-e053-2995a90a90f5a1ba4e03-1c3d-e7f9-e053-2995a90a07b92020-06-03WarningsExact identifier
spl id: a736838b-b55c-f066-e053-2995a90a90f5
spl set id: a1ba4e03-1c3d-e7f9-e053-2995a90a07b9

Reported adverse events (FAERS/openFDA)#

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