DONOR PREP KIT- isopropyl alcohol and iodine
CareFusion 213 LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active ingredient

Frepp

Isopropyl alcohol 70% v/v USP

Sepp

Iodine 2% w/v USP

Purpose

Antiseptic

Uses

Frepp

•: for the preparation of the patient's skin prior to injection

Sepp

•: patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use with electrocautery procedures

Do not use

Frepp

on patients with known allergies to isopropyl alcohol

Sepp

on patients with known allergies to ethyl alcohol or iodine

When using this product

keep out of eyes, ears, and mouth

Stop use and ask a doctor if

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

Keep out of reach of children.

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

Directions

Frepp

•: locate the vein to be used
•: remove Frepp from kit. Hold in a horizontal position and pinch handle once to break ampule. Do not continue to squeeze handle.
•: place sponge on selected venipuncture site and depress once or twice to saturate sponge
•: scrub vigorously for at least 30 seconds
•: allow to dry

Sepp

•: remove Sepp. Hold in downward position and pinch center of Sepp to crush ampule.
•: use repeated back-and-forth strokes of the applicator for approximately 30 seconds or apply iodine tincture to venipuncture site starting at center and moving outward in concentric circles to periphery. Allow to dry.
•: proceed with collection of blood
•: discard unused components

Other information

: store below 30 °C (86 °F)

Inactive ingredients

Frepp

•: USP purified water

Sepp

•: USP purified water
•: ethyl alcohol
•: sodium iodide USP

Questions?

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

Package/Label Principal Display Panel

Donor Prep Kit Carton

DONOR PREP KIT

NDC 54365-201-99

Single Use

Latex Free

Contents STERILE if primary package is intact

20 Kits

Each kit contains:

1 FREPP - isopropyl alcohol

Net 1.1 ml

1 SEPP - iodine tincture 2% USP

Net 0.67 ml

DONOR PREP KIT

CareFusion

Leawood, KS 66211

1.800.523.0502

Made in

Store below 30 °C or 86 °F

For external use only

For hospital and professional use only

DONOR PREP KIT
isopropyl alcohol and iodine kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54365-201

Packaging
#	Item Code	Package Description
1	NDC:54365-201-99	1 in 1 POUCH

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 AMPULE	1.1 mL
Part 2	1 AMPULE	0.67 mL

Part 1 of 2

IPA FREPP
isopropyl alcohol solution

Product Information
Item Code (Source)	NDC:54365-170
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL)	ISOPROPYL ALCOHOL	0.7 mL in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER

Packaging
#	Item Code	Package Description
1	NDC:54365-170-02	1.1 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/1988

Part 2 of 2

IODINE SEPP
iodine tincture

Product Information
Item Code (Source)	NDC:54365-161
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (IODINE)	IODINE	20 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM IODIDE
ALCOHOL
WATER

Packaging
#	Item Code	Package Description
1	NDC:54365-161-01	0.67 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/1988	01/31/2012

Labeler - CareFusion 213 LLC (826496312)

Establishment
Name	Address	ID/FEI	Business Operations
CareFusion 213 LLC		826496312	ANALYSIS(54365-201), LABEL(54365-201), MANUFACTURE(54365-201), PACK(54365-201)

Revised: 01/2012

Document Id: a177f083-5e63-4f09-8f74-0695386c8913

Set id: 7e231b70-6523-4aa3-9ac6-2f7a7b8263ce

Version: 4

Effective Time: 20120131

CareFusion 213 LLC