FDA.reportPublic FDA data

ISOPROPYL ALCOHOL

Manufacturer
LernaPharm Loris Inc.
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:23:32

Label at a glance#

ProductISOPROPYL ALCOHOL
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

image of outer box packagingimage of outer box packagingimage of individual swab packageimage of individual swab packageNDC 68356-117-02 PRODUCT # 117-02U


LORIS - ALCOHOL SWABS


MEDIUM

Saturated with 70% v/v isopropyl alcohol, USP

Single use only ● For external use only ● Easy to use ● Economical

Antiseptic

Non-Sterile Solution and Swab


200 units

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68356-117ISOPROPYL ALCOHOL SWAB [LERNAPHARM LORIS INC.]8Legacy NDC20231022_4f5d9224-63d8-4256-a5ea-b2d16ccbb89b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163023
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163023
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68356-11768356-117-02

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
4c4df85f-59d2-000b-e063-6294a90a3aa74f5d9224-63d8-4256-a5ea-b2d16ccbb89b2026-03-05WarningsExact identifier
spl set id: 4f5d9224-63d8-4256-a5ea-b2d16ccbb89b

Reported adverse events (FAERS/openFDA)#

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