FDA.reportPublic FDA data

Alcohol Prep Pad

Manufacturer
Jianerkang Medical Co., Ltd
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:57:22

Label at a glance#

ProductAlcohol Prep Pad
Active ingredientISOPROPYL ALCOHOL
Label structure11 sections

Storage and handling

Other Information Store at room temperature 15 -30 C (59 -86 F) o o o o

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Isopropyl Alcohol 70%

OTC - PURPOSE SECTION

Purpose

Antiseptic

INDICATIONS & USAGE SECTION

Use

For preparation of the skin prior to an injection

WARNINGS SECTION

Warnings

For external use only

Flammable, keep away from fire or flame

OTC - DO NOT USE SECTION

Do Not Use

with electrocautery procedures

in the eyes, if contact occurs, flush eyes with water

OTC - STOP USE SECTION

Stop Use

If irritation and redness develop.

If condition persists consult your health care practitioner

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep our of reach of children

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

DOSAGE & ADMINISTRATION SECTION

Directions

Wipe injection site vigorously and discard

STORAGE AND HANDLING SECTION

Other Information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredient

purified water

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pouch LabelPouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797544isopropyl alcohol 70 % Medicated PadPSN8
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD8
797544isopropyl alcohol 70 % Medicated PadSY8
797544isopropyl alcohol 70 % Topical ClothSY8
797544isopropyl alcohol 70 % Topical SwabSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-3008-3Alcohol Prep Pad0.4 mL in 1 POUCHSWAB0.48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-3008ALCOHOL PREP PAD (ISOPROPYL ALCOHOL) SWAB [JIANERKANG MEDICAL CO., LTD]8Current NDC, Legacy NDC, 1 package rows20231023_c1273e40-5c09-435b-adf3-e352fdd01e9e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163022
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163022

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
34645-300834645-3008-3

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 · Source PDF

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 PadISOPROPYL ALCOHOLJianerkang Medical Co., Ltdc1273e40-5c09-435b-adf3-e352fdd01e9e2023-10-23WarningsExact identifier
ndc (package): 34645-3008-3
ndc (product): 34645-3008
ndc11 (package): 34645300803
spl id: 085cd253-6c17-3a99-e063-6394a90ab93d
spl set id: c1273e40-5c09-435b-adf3-e352fdd01e9e

Reported adverse events (FAERS/openFDA)#

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