FDA.reportPublic FDA data

Alcohol Prep

Manufacturer
Acme United Corporation | Dynarex Corporation
Effective date
2016-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:44:41

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

Purpose

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 damaged or open.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - Box

First Aid APPFirst Aid APP

Perincipal Display Panel Pouch

First Aid APP PouchFirst Aid APP Pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN2
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD2
797544isopropyl alcohol 70 % Medicated PadSY2
797544isopropyl alcohol 70 % Topical ClothSY2
797544isopropyl alcohol 70 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0924-0012-062020-01-31C16284748780-19d75b9d0-2725-f424-e053-dadaa90a57ceAcme Sterile Alcohol Prep Pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0924-0012-06Alcohol Prep100 in 1 BOXSWAB1002
0924-0012-06Alcohol Prep0.55 mL in 1 PACKETSWAB0.552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0924-0012ALCOHOL PREP (ISOPROPYL ALCOHOL ) SWAB [ACME UNITED CORPORATION]2Legacy NDC, 2 package rows20160121_ac749da4-d75d-4801-a80e-572475cc916d.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
0924-00120924-0012-06

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
ee8eb736-7441-4e06-96dc-0ab27e935dd1ac749da4-d75d-4801-a80e-572475cc916d2016-01-20WarningsExact identifier
spl id: ee8eb736-7441-4e06-96dc-0ab27e935dd1
spl set id: ac749da4-d75d-4801-a80e-572475cc916d

Reported adverse events (FAERS/openFDA)#

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