BLOOD CULTURE PREP KIT - isopropyl alcohol and iodine   
CareFusion 213 LLC

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ACTIVE INGREDIENTS

70% Isopropyl Alcohol Frepp

Isopropyl alcohol 70% v/v, USP

Iodine Tincture 2% Sepp

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 Tincture 2% Sepp

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. 260307

Blood Culture
Prep Kit II

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

BLOOD CULTURE PREP KIT  isopropyl alcohol and iodine   kit

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54365-200

Packaging # NDC Package Description Multilevel Packaging 1 54365-200-99 1 KIT In 1 POUCH None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 APPLICATOR   1.1 mL Part 2 1 AMPULE   0.67 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 70 mL  in 100 mL

Inactive Ingredients Ingredient Name Strength Water 30 mL  in 100 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54365-170-02 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

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 Sodium Iodide 23.5 mg  in 1 mL Water 48.65 mL  in 100 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 .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

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