FDA.reportPublic FDA data

STERILE ALCOHOL PREP PADS

Manufacturer
Mcure Health Solutions Inc. | Taizhou Kangping Medical Science And Technology Co., Ltd
Effective date
2017-06-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:50:03

Label at a glance#

ProductSTERILE ALCOHOL PREP PADS
Active ingredientISOPROPYL ALCOHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Isopropyl Alcohol, 70% v/v

OTC - PURPOSE SECTION

Purpose

Antiseptic

DOSAGE & ADMINISTRATION SECTION

Uses

  • For preparation of the skin prior to an injection

INDICATIONS & USAGE SECTION

Direction

  • Wipe injection site vigorously and discard

WARNINGS SECTION

Warnings
For External Use Only
Flammable, keep away from fire or flame.

Do not use

  • With electrocautery procedures
  • In the eyes

Stop use and ask a doctor

  • if irritation and redness develops
  • If condition persists for more than 72 hours, consult a physician

INACTIVE INGREDIENT SECTION

Inactive Ingredients

  • Water

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

300300

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN5
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD5
797544isopropyl alcohol 70 % Medicated PadSY5
797544isopropyl alcohol 70 % Topical ClothSY5
797544isopropyl alcohol 70 % Topical SwabSY5

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52486-153-012020-01-31C16284748780-19d75b9d0-5641-f424-e053-dadaa90a57ce4d9e96f7-035e-24b4-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52486-153-01STERILE ALCOHOL PREP PADS0.45 mL in 1 POUCHSWAB0.455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52486-153STERILE ALCOHOL PREP PADS (ISOPROPYL ALCOHOL SWAB) SWAB [MCURE HEALTH SOLUTIONS INC.]5Legacy NDC, 1 package rows20170606_4d9e96f7-035e-24b4-e054-00144ff88e88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52486-15352486-153-01

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
50ffb5ff-9b02-1f02-e054-00144ff8d46c4d9e96f7-035e-24b4-e054-00144ff88e882017-06-02WarningsExact identifier
spl id: 50ffb5ff-9b02-1f02-e054-00144ff8d46c
spl set id: 4d9e96f7-035e-24b4-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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