FDA.reportPublic FDA data

Isopropyl Alcohol

Manufacturer
INEOS COMPOSITES US, LLC | INEOS COMPOSITES, US LLC
Effective date
2021-09-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:34:30

Label at a glance#

ProductIsopropyl Alcohol
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Indications and uses

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

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 59-86°F

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Uses

INDICATIONS & USAGE SECTION

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

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

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 - 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 59-86°F

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Methylacrylic Acid-Ethyl Acrylate Copolymer, Glycerin, Aminomethylpropanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50mL NDC 75284-0200-1 INEOS Hygienics Hand Sanitizer Gel 50mLINEOS Hygienics Hand Sanitizer Gel 50mL250ml NDC 75284-0200-8 Hand Sanitizer Gel 250mLHand Sanitizer Gel 250mL

500mL NDC 75284-0200-9

Hand Sanitizer Gel 500mLHand Sanitizer Gel 500mL

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
75284-020075284-0200-1, 75284-0200-8, 75284-0200-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT

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
cece0dca-6d02-c1e7-e053-2a95a90a0095badaf346-7ef4-8b02-e053-2a95a90a0ea32021-10-20WarningsExact identifier
spl set id: badaf346-7ef4-8b02-e053-2a95a90a0ea3

Reported adverse events (FAERS/openFDA)#

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