FDA.reportPublic FDA data

First Aid Antiseptic Isopropyl Alcohol Pad

Manufacturer
Fourstar Group USA, Inc.
Effective date
2024-11-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:40:00

Label at a glance#

ProductFirst Aid Antiseptic Isopropyl Alcohol Pad
Active ingredientISOPROPYL ALCOHOL
Label structure7 sections

Dosage and administration

clean the affected area may be covered with a sterile bandage

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol, 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

first aid to help reduce bacterial contamination in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only.

Flammable -keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • in case of deep or puncture wounds, animal bites, or serious burns, consult a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • do not use longer than 1 week unless directed by a doctor

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

  • clean the affected area
  • may be covered with a sterile bandage

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature 15°-30°C (59°-86°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN1
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD1
797544isopropyl alcohol 70 % Medicated PadSY1
797544isopropyl alcohol 70 % Topical ClothSY1
797544isopropyl alcohol 70 % Topical SwabSY1

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-137-00First Aid Antiseptic Isopropyl Alcohol Pad0.4 mL in 1 PATCHLIQUID0.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-137FIRST AID ANTISEPTIC ISOPROPYL ALCOHOL PAD (ISOPROPYL ALCOHOL) LIQUID [FOURSTAR GROUP USA, INC.]1Current NDC, 1 package rows20241204_27edf5dc-3e68-bdd0-e063-6394a90ac485.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
80684-13780684-137-00

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
First Aid Antiseptic Isopropyl Alcohol PadISOPROPYL ALCOHOLFourstar Group USA, Inc.27edf5dc-3e68-bdd0-e063-6394a90ac4852024-11-27WarningsExact identifier
ndc (package): 80684-137-00
ndc (product): 80684-137
ndc11 (package): 80684013700
spl id: 27edf5e3-ca82-0411-e063-6394a90ab782
spl set id: 27edf5dc-3e68-bdd0-e063-6394a90ac485

Reported adverse events (FAERS/openFDA)#

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