FREPP SEPP KIT - povidone iodine   
CareFusion 213 LLC

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Frepp®-Sepp® Kit Drug Facts

Active ingredient

Frepp

Povidone-iodine 2% w/v USP

Sepp

Povidone-iodine 10% w/v USP

Purpose

Antiseptic

Uses

• Patient preoperative skin preparation: Helps to reduce bacterial that potentially can cause skin infection

Warnings

For external use only

Do not use

on patients with known allergies to povidone-iodine or Igepal CO-630

When using this product

keep out of eyes, ears, and mouth

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. 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.
• apply povidone-iodine 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

• USP purified water
• Igepal CO-630

Questions?

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

Package/Label Principal Display Panel

Frepp/Sepp Kit

NDC 54365-202-99

Single
Latex Free

Contents STERILE if primary package is intact

20 Kits

Each kit contains:

1 FREPP - povidone iodine 2% aqueous solution

Net 1.1 ml

1 SEPP - povidone iodine 10% USP

Net 0.67 ml

FREPP SEPP KIT  povidone iodine   kit

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 54365-202

Packaging # NDC Package Description Multilevel Packaging 1 54365-202-99 1 KIT In 1 POUCH None

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

Part 1 of 2 SEPP  povidone iodine   solution

Product Information NDC Product Code (Source) 54365-145 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE 99.3 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength WATER 867.3 mg  in 1 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54365-145-01 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

Part 2 of 2 FREPP  povidone iodine   solution

Product Information NDC Product Code (Source) 54365-301 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE 20.67 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength WATER 967 mg  in 1 mL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 54365-301-01 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 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, MANUFACTURE

Revised: 05/2010CareFusion 213 LLC