FDA.reportPublic FDA data

Cut Care Alcohol Prep Pad

Manufacturer
Zeus Medical Holdings LLC
Effective date
2013-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:54

Label at a glance#

ProductCut Care Alcohol Prep Pad
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Dosage and administration

Wipe injection site vigorously and discard

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 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.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Irritation or redness develops
  • condition persists for more than 72 hours

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○ - 30○C (59○F – 86○F)

  • avoid excessive heart

Inactive Ingredient

INACTIVE INGREDIENT SECTION

purified water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53439-100-10
Cut Care
Alcohol Prep Pad
Saturated with 70% Isopropyl Alcohol
Contents: 100 Pouches

PRINCIPAL DISPLAY PANEL NDC 53439-100-10 Cut Care Alcohol Prep Pad Saturated with 70% Isopropyl Alcohol Contents: 100 PouchesPRINCIPAL DISPLAY PANEL NDC 53439-100-10 Cut Care Alcohol Prep Pad Saturated with 70% Isopropyl Alcohol Contents: 100 Pouches

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53439-100-102019-11-27C16284748780-19855d018-e588-cd31-e053-dbdaa90ab51aCut Care Alcohol Prep Pad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53439-100-01Cut Care Alcohol Prep Pad1 in 1 POUCHSWAB11
53439-100-10Cut Care Alcohol Prep Pad100 in 1 CARTONSWAB1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53439-100CUT CARE ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [ZEUS MEDICAL HOLDINGS LLC]1Legacy NDC, 2 package rows20130915_4f3a151c-9544-4fbe-9ff0-1be625b843ed.zip

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
53439-10053439-100-01, 53439-100-10

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
cda8f72f-d34c-4a2d-8762-24ff2717311b4f3a151c-9544-4fbe-9ff0-1be625b843ed2013-09-09WarningsExact identifier
spl id: cda8f72f-d34c-4a2d-8762-24ff2717311b
spl set id: 4f3a151c-9544-4fbe-9ff0-1be625b843ed

Reported adverse events (FAERS/openFDA)#

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