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Name:Blood Culture Prep Kit
Manufacturer:Carefusion 213 Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

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

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.

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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

Blood Culture Prep Carton Display Panel

Carton Primary Display Panel

BLOOD CULTURE KIT

NDC 54365-200-99

Single Use

Latex Contents STERILE if primary container is intact

20 Kits

Each kit contains:

1 FREPP - 70% isopropyl alcohol, Net 1.1 ml

1 SPP - iodine tincture 2% USP, Net 0.67 ml

BLOOD CULTURE PREP KIT II

CareFusion

Leawood, KS 66211

1.800.523.0502

Made in SA

Store below 30 °C or 86 °F

For external use only

For hospital and professional use only


BLOOD CULTURE PREP KIT 
isopropyl alcohol and iodine kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54365-200
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54365-200-99 1 KIT ( 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
Item Code (Source) NDC: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
# Item Code 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
Item Code (Source) NDC: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
# Item Code 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: 05/2010 CareFusion 213 LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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