FDA.reportPublic FDA data

Alcohol Prep

Manufacturer
Aero-Med Ltd
Effective date
2015-01-05
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:41:16

Label at a glance#

ProductAlcohol Prep
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

Stop use and ask a doctor if: Irritation or redness develops condition persists for more than 72 hours Cleansing of an injection site

Dosage and administration

Wipe injection site vigorously and discard

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                       Purpose

Isopropyl Alcohol 70% v/v                         Antiseptic

Use:Aeromed sterile alcohol prep

OTC - PURPOSE SECTION

For preparation of the skin prior to injection.

Warnings:

WARNINGS SECTION

  • For external use only
  • Flammable, keep away from flame or fire
  • Not for use with electrocautinary devices or procedures
  • Do not use in eyes
  • Sterile unless package is open or damaged

Indications and Usage:

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if:

  • Irritation or redness develops
  • condition persists for more than 72 hours
  • Cleansing of an injection site

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wipe injection site vigorously and discard

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredient

  • Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aeromed Sterile Alcohol Prep

alcohol_prepalcohol_prep

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN6
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD6
797544isopropyl alcohol 70 % Medicated PadSY6
797544isopropyl alcohol 70 % Topical ClothSY6
797544isopropyl alcohol 70 % Topical SwabSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42449-122-132020-01-31C16284748780-19d75b9cf-e2a6-f424-e053-dadaa90a57ceSterile Alcohol Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42449-122-13Alcohol Prep200 in 1 BOXSWAB2006
42449-122-13Alcohol Prep20 in 1 CASESWAB206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42449-122ALCOHOL PREP (ISOPROPYL ALCOHOL) SWAB [AERO-MED LTD]6Legacy NDC, 2 package rows20150105_53f1a366-209a-40e4-a5db-b43321731b3e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163026
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163026
WATERINACTIVE INGREDIENT059QF0KO0R6

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
42449-12242449-122-13

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
6fd958a0-da76-4464-9411-485ec698ee6b53f1a366-209a-40e4-a5db-b43321731b3e2015-01-05WarningsExact identifier
spl id: 6fd958a0-da76-4464-9411-485ec698ee6b
spl set id: 53f1a366-209a-40e4-a5db-b43321731b3e

Reported adverse events (FAERS/openFDA)#

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