Donor Prep Kit

Dosage form: kit
Ingredients: ISOPROPYL ALCOHOL 0.7mL in 1mL; IODINE 20mg in 1mL
Labeler: CareFusion 213 LLC
NDC Code: 54365-201

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-201
Packaging
#Item CodePackage Description
1NDC:54365-201-991 KIT (KIT) in 1 POUCH
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 APPLICATOR 1.1 mL
Part 21 AMPULE 0.67 mL
Part 1 of 2
FREPP 
isopropyl alcohol solution
Product Information
Item Code (Source)NDC:54365-170
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:54365-170-021.1 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/1988
Part 2 of 2
SEPP 
iodine tincture
Product Information
Item Code (Source)NDC:54365-161
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODINE (IODINE) IODINE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM IODIDE 
ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:54365-161-010.67 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/1988
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/1988
Labeler - CareFusion 213 LLC (831684456)
Establishment
NameAddressID/FEIOperations
CareFusion 213 LLC830430810ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 05/2010
 
CareFusion 213 LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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