FDA.reportPublic FDA data

PDI Alcohol Prep Pad

Manufacturer
Profesional Disposables International, Inc.
Effective date
2012-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:30:37

Label at a glance#

ProductPDI Alcohol Prep Pad Large and Medium
Active ingredientAlcohol
Label structure8 sections

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

For preparation of the skin prior to an injection

Warnings

WARNINGS SECTION


For external use only.
Flammable, keep away from fire or flame.
___________________________________________________

Do not
  • use with electrocautery procedures
  • use in the eyes
  • apply to irritated skin
___________________________________________________

Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

SPL UNCLASSIFIED SECTION


  • Open packet
  • Remove pad
  • Apply topically as needed to cleanse intended area. Discard after single use.

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 15-30oC (59-86oF)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Purified water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDI(R)

Alcohol Prep Pad

Large and Medium

For Professional and Hospital Use

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376
USA - 1800-999-6423
www.pdipdi.com    Made in USA

Large Packet  Label
Image of Large Packet Label
Image of Large Packet Label
Large Box Label
Image of Large Box Label
Image of Large Box Label
Medium Packet Label
Image of Medium Packet Label
Image of Medium Packet Label
Medium Box Label
Image of Medium Box Label
Image of Medium Box Label

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

See box for additional information.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10819-3912-12025-11-10C16284748780-19d75b9d0-dc0c-f424-e053-dadaa90a57ceDRUG FACTS
10819-3912-22025-11-10C16284748780-19d75b9d0-dc0c-f424-e053-dadaa90a57ceDRUG FACTS
10819-3912-12020-01-31C16284748780-19d75b9d0-dc0c-f424-e053-dadaa90a57ceDRUG FACTS
10819-3912-22020-01-31C16284748780-19d75b9d0-dc0c-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10819-3912PDI ALCOHOL PREP PAD LARGE AND MEDIUM (ALCOHOL) CLOTH [PROFESIONAL DISPOSABLES INTERNATIONAL, INC.]2Legacy NDC20120119_6d108776-9383-4e23-9b20-5ea73c2af47f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AlcoholACTIVE INGREDIENT3K9958V90M2
AlcoholACTIVE MOIETY3K9958V90M2
WaterINACTIVE INGREDIENT059QF0KO0R2

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
10819-391210819-3912-2, 10819-3912-1

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
Alcohol3K9958V90MACTIB
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
4341908a-b392-44ce-e063-6294a90a503d6d108776-9383-4e23-9b20-5ea73c2af47f2025-11-10WarningsExact identifier
spl set id: 6d108776-9383-4e23-9b20-5ea73c2af47f

Reported adverse events (FAERS/openFDA)#

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