DONOR PREP KIT - isopropyl alcohol and iodine   
CareFusion 213 LLC

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ACTIVE INGREDIENTS

Isopropyl alcohol 70% v/v, USP

Iodine 2% w/v, USP

PURPOSE

Antiseptic

USE

70% Isopropyl Alcohol Frepp

• for the preparation of the patient’s skin prior to injection

Iodine Tincture 2% 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

70% Isopropyl Alcohol Frepp

with electrocautery procedures

on patients with known allergies to isopropyl alcohol

Iodine 2% w/v, USP

with electrocautery procedures

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, or allergic reaction occurs. These may be signs of a serious condition.

Keep out of reach of children.

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

DIRECTIONS

70% Isopropyl Alcohol 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

Iodine Tincture 2% 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

70% Isopropyl Alcohol Frepp

• USP purified water

Iodine Tincture 2% Sepp

• USP purified water, ethyl alcohol and sodium iodide, USP

QUESTIONS?

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

• www.enturia.com

PRINCIPAL DISPLAY PANEL

Cat. No. 260311

Frepp NDC 54365-170-02

Sepp NDC 54365-161-01

Donor Prep Kit

20 KITS – Each kit contains:
1 Frepp® – 70% Isopropyl Alcohol Solution, Net 1.1 ml (DIN 00821551)
1 Sepp® – Iodine Tincture 2% USP, Net 0.67 ml Contains 47% Ethyl Alcohol (DIN 02048825)

LATEX FREE

FOR EXTERNAL USE ONLY • FOR HOSPITAL & PROFESSIONAL USE ONLY
CONTENTS STERILE IF PRIMARY CONTAINER IS INTACT • STORE BELOW 30 °C OR 86 °F

enturia™
Leawood, KS 66211
1-800-523-0502
www.enturia.com

DONOR PREP KIT  isopropyl alcohol and iodine   kit

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

Packaging # NDC Package Description Multilevel Packaging 1 54365-201-99 1 KIT In 1 POUCH None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 AMPULE   .67 mL Part 2 1 APPLICATOR   1.1 mL

Part 1 of 2 FREPP  isopropyl alcohol   solution

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isopropyl Alcohol (Isopropyl Alcohol) Isopropyl Alcohol 0.70 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54365-170-02 0.67 mL In 1 AMPULE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 02/01/1988

Part 2 of 2 SEPP  iodine   tincture

Product Information NDC Product Code (Source) 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 Water 0.4865 mL  in 1 mL Sodium Iodide 23.5 mg  in 1 mL Alcohol 47 mL  in 100 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54365-161-01 1.1 mL In 1 APPLICATOR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 02/01/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	02/01/1988

Labeler - CareFusion 213 LLC (831684456)

Establishment
Name	Address	ID/FEI	Operations
CareFusion 213 LLC		830430810	manufacture

Revised: 12/2009CareFusion 213 LLC