FDA.reportPublic FDA data

Isopropyl alcohol

Manufacturer
Freds Inc
Effective date
2023-11-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:19:59

Label at a glance#

ProductIsopropyl alcohol 50 percent
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Dosage and administration

clean affected area apply small amount of this product on the area 1-3 times daily if bandaged, let dry first may be covered with a sterile bandage

Label contents#

Full prescribing information#

Active ingredient (by volume)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol (50% conc)

Purpose

OTC - PURPOSE SECTION

first aid antiseptic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent the risk of infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

  • if taken internally serious gastric disturbances will result

Flammable, keep away from fire or flame.

  • use only in a well-ventilated area; fumes may be toxic

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • do not apply over large areas of the body
  • do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply small amount of this product on the area 1-3 times daily
  • if bandaged, let dry first
  • may be covered with a sterile bandage

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

Inactive ingredients

INACTIVE INGREDIENT SECTION

 purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rubbing Alcohol

50% Isopropyl

FIRST AID ANTISEPTIC

FL OZ (mL)

TAMPER EVIDENT: DO NOT USE IF THE PRINTED SAFETY FOIL UNDER THE CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: Fred's, Inc.

4300 NEW GETWELL RD,

MEMPHIS,TN38118

www.fredsinc.com

Questions or comments?

Call 1-855-331-FRED (3733)

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FRED's PHARMACY Rubbing Alcohol
FRED's PHARMACY Rubbing Alcohol

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163021
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163021
WATERINACTIVE INGREDIENT059QF0KO0R1

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
55315-27155315-271-16

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
ISOPROPYL ALCOHOLND2M416302ACTIB
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
d0458b37-2d18-41e6-bdcb-37c445bbc659e08b6c22-2043-47ab-b80f-a8aecdabe0c32023-11-28WarningsExact identifier
spl id: d0458b37-2d18-41e6-bdcb-37c445bbc659
spl set id: e08b6c22-2043-47ab-b80f-a8aecdabe0c3

Reported adverse events (FAERS/openFDA)#

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