FDA.reportPublic FDA data

Isopropyl Alcohol Antiseptic 75% Topical Solution

Manufacturer
ANI Pharmaceuticals, Inc.
Effective date
2021-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:24:22

Label at a glance#

ProductIsopropyl Alcohol Antiseptic 75%
Active ingredientISOPROPYL ALCOHOL
Label structure10 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[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

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

Stop use and ask a doctor

OTC - ASK DOCTOR SECTION

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.

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

OTHER SAFETY INFORMATION

  • Store between 15° to 30°C (59° to 86°F)
  • Avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Questions or comments?

OTC - QUESTIONS SECTION

1-800-308-6755

 

SPL UNCLASSIFIED SECTION

Manufactured by:
ANI Pharmaceuticals, Inc.
Baudette, MN 56623
 
10332 Rev 04/20

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62559-940-10
Isopropyl Alcohol Antiseptic 75%
Topical Solution
Antiseptic Hand Rub
Non-sterile Solution
For use during Coronavirus Disease 2019 (COVID-19) pandemic only. Discard once normal supply has resumed.
Net Contents: 1,000 mL
LabelLabel

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
62559-94062559-940-10

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
58fff808-4911-4ebc-8d85-161096ab1a786a7f74e8-2f20-44a6-9ccb-99bae1a2099f2021-12-07WarningsExact identifier
spl id: 58fff808-4911-4ebc-8d85-161096ab1a78
spl set id: 6a7f74e8-2f20-44a6-9ccb-99bae1a2099f

Reported adverse events (FAERS/openFDA)#

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