FDA.reportPublic FDA data

STERILE ALCOHOL PREP PADS

Manufacturer
PurCel Labs LLC | Zhejiang Qimei Cosmetics Co., Ltd.
Effective date
2023-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:27:29

Label at a glance#

ProductSTERILE ALCOHOL PREP PADS
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Indications and uses

For preparation of the skin prior to an injection

Dosage and administration

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

Storage and handling

Store at room temperature 59-86°F(15-30°C). Contents STERILE in unopened,undamaged inner package.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION


Isopropyl Alcohol, 70% V/V

Purpose

OTC - PURPOSE SECTION


First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION


For preparation of the skin prior to an injection

Warnings

WARNINGS SECTION


For external use only.

Flammable, keep away from fifire or flflame

OTC - DO NOT USE SECTION


Do not use with electrocutery procedures
Do not use in the eyes
Do not apply to irritated skin

OTC - STOP USE SECTION


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.

USER SAFETY WARNINGS SECTION


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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other informations

STORAGE AND HANDLING SECTION


Store at room temperature 59-86°F(15-30°C). Contents STERILE in unopened,undamaged inner package.

Inactive ingredient

INACTIVE INGREDIENT SECTION


Purifified Water

Package label.principal display panel

NDC 83584-200-01NDC 83584-200-01NDC 83584-200-02NDC 83584-200-02NDC 83584-200-03NDC 83584-200-03NDC 83584-200-04NDC 83584-200-04

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
83584-20083584-200-01, 83584-200-02, 83584-200-03, 83584-200-04

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
23daba8c-09e2-35a1-e063-6294a90ab50e01dcfd14-7a1f-98fa-e063-6294a90a03362024-10-06WarningsExact identifier
spl set id: 01dcfd14-7a1f-98fa-e063-6294a90a0336

Reported adverse events (FAERS/openFDA)#

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