FDA.reportPublic FDA data

Alcohol Prep Pad Sterile

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:21

Label at a glance#

ProductAlcohol Prep Pad Sterile
Active ingredientISOPROPYL ALCOHOL
Label structure7 sections

Dosage and administration

Wipe injection site vigorously and discard

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic Cleanser

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

OTC - DO NOT USE SECTION

  • with electrocautery procedures
  • In the eyes. If contact occurs, flush eyes with water

Stop Use

OTC - STOP USE SECTION

If irritation and redness develop. If condition persists consult your health care practitioner.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wipe injection site vigorously and discard

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 15° - 30°C (59° - 86° F)

Inactive Ingredient

INACTIVE INGREDIENT SECTION

purified water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN3
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD3
797544isopropyl alcohol 70 % Medicated PadSY3
797544isopropyl alcohol 70 % Topical ClothSY3
797544isopropyl alcohol 70 % Topical SwabSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-0005-1Alcohol Prep Pad Sterile0.5 mL in 1 PATCHPATCH0.53
34645-0005-1Alcohol Prep Pad Sterile1 in 1 POUCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-0005ALCOHOL PREP PAD STERILE (ISOPROPYL ALCOHOL) PATCH [JIANERKANG MEDICAL CO., LTD]3Current NDC, Legacy NDC, 2 package rows20231023_a4d1f759-7f35-d277-e053-2a95a90abc8c.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
34645-000534645-0005-1

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
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
Alcohol Prep Pad SterileISOPROPYL ALCOHOLJianerkang Medical Co., Ltda4d1f759-7f35-d277-e053-2a95a90abc8c2023-10-23WarningsExact identifier
ndc (package): 34645-0005-1
ndc (product): 34645-0005
ndc11 (package): 34645000501
spl id: 085d20a0-8c95-0d49-e063-6394a90a97f5
spl set id: a4d1f759-7f35-d277-e053-2a95a90abc8c

Reported adverse events (FAERS/openFDA)#

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