FDA.reportPublic FDA data

ISOPROPYL ALCOHOL PREP PAD STERILE

Manufacturer
LernaPharm Loris Inc. | STERIS Isomedix Services
Effective date
2019-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:06:20

Label at a glance#

ProductISOPROPYL ALCOHOL PREP PAD STERILE
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Indications and uses

For preparation of the skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection.

Dosage and administration

Tear open individual swab and apply product to the injection site prior to an injection. Rub skin briskly in circular motion from injection site outward.

Storage and handling

Store at room temperature between 59 - 86 0 F (15 - 30 0 C)

Label contents#

Full prescribing information#

Active Ingredient (in each swab)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 70%v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

For preparation of the skin prior to an injection. Helps reduce bacteria that potentially can cause skin infection.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame. Do not use with electrocautery procedures. For external use only. Do not use in the eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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

Tear open individual swab and apply product to the injection site prior to an injection. Rub skin briskly in circular motion from injection site outward.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature between 59 - 86 0F (15 - 30 0C)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 68356-104-03               Product No. 104-03U

Antiseptic Isopropyl Alcohol Pad

LORIS

Antiseptic

Sterile Solution and Swab

Unless package is opened or damaged

200 Units

IPA Sterile Swab 68356-104 Individual Swab PacketIPA Sterile Swab 68356-104 Individual Swab Packet

IPA Sterile Swab 68356-104 Outer 200 count cartonIPA Sterile Swab 68356-104 Outer 200 count carton

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
68356-10468356-104-03

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
e4553641-d616-ed2f-e053-2995a90aeae3b5d46429-b22d-4159-b9f4-61e6716598672022-07-21WarningsExact identifier
spl set id: b5d46429-b22d-4159-b9f4-61e671659867

Reported adverse events (FAERS/openFDA)#

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