FDA.reportPublic FDA data

Isopropyl Alcohol Sepp

Manufacturer
CareFusion 213 LLC | CareFusion 2200, Inc
Effective date
2013-06-01
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-02 01:38:48

Label at a glance#

ProductIsopropyl Alcohol Sepp
Active ingredientISOPROPYL ALCOHOL
Label structure9 sections

Dosage and administration

1 remove the applicator wrapper. Do not touch the applicator tip. 2 with the applicator tip facing downward, pinch the barrel of the applicator ONCE to release the antiseptic. 3 press the applicator tip against the patient’s skin. With gentle back and forth actions apply solution to the treatment area. 4 the area covered should be allowed to dry naturally. 5 discard after single use

Storage and handling

  store below 30 °C (86 °F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 70% v/v, USP

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • for the preparation of the skin prior to injection.

Warnings

WARNINGS SECTION

For external use only. Flammable: Keep away from fire or flame

Do not use with electrocautery procedures

Do not use

OTC - DO NOT USE SECTION

  • In the eyes
  • on patients with known allergies to isopropyl alcohol

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

irritation, sensitization, or allergic reaction occurs. You may report side effects to FDA at 1-800-FDA-1088.

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

  1. remove the applicator wrapper. Do not touch the applicator tip.
  2. with the applicator tip facing downward, pinch the barrel of the applicator ONCE to release the antiseptic.
  3. press the applicator tip against the patient’s skin. With gentle back and forth actions apply solution to the treatment area.
  4. the area covered should be allowed to dry naturally.
  5. discard after single use

Other information

STORAGE AND HANDLING SECTION

  • store below 30 °C (86 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • USP purified water

Questions?

OTC - QUESTIONS SECTION

  1. Call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IPA Sepp Carton Primary Display Panel
IPA Sepp Carton Primary Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54365-170-012023-04-27C16284748780-19855e2a2-4c23-60a7-e053-dbdaa90a05bd70% IPA Sepp ®
54365-170-012019-11-27C16284748780-19855e2a2-4c23-60a7-e053-dbdaa90a05bd70% IPA Sepp ®

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ISOPROPYL ALCOHOLACTIVE INGREDIENTND2M4163027
ISOPROPYL ALCOHOLACTIVE MOIETYND2M4163027
WATERINACTIVE INGREDIENT059QF0KO0R7

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
54365-17054365-170-01

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
2162187a-518e-2f47-e054-00144ff88e88597a86c0-99f3-4df6-be4a-208106a7799a2022-11-21WarningsExact identifier
spl set id: 597a86c0-99f3-4df6-be4a-208106a7799a

Reported adverse events (FAERS/openFDA)#

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