Donor Prep Kit

Dosage Form: preoperative skin preparation
Donor Prep Kit Drug Facts

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 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 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 0.7 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 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 part333A 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   ALCOHOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54365-161-01 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 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

Labeler - CareFusion 213 LLC (831684456)

Establishment
Name	Address	ID/FEI	Operations
CareFusion 213 LLC		830430810	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 05/2010CareFusion 213 LLC