Frepp Sepp Kit

Dosage form: kit
Ingredients: POVIDONE-IODINE 99.3mg in 1mL; POVIDONE-IODINE 20.67mg in 1mL
Labeler: CareFusion 213 LLC
NDC Code: 54365-202

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.

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 bacteria 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 and 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 Carton Primary 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-202
Packaging
#Item CodePackage Description
1NDC:54365-202-991 KIT (KIT) in 1 POUCH
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 AMPULE 0.67 mL
Part 21 APPLICATOR 1.1 mL
Part 1 of 2
SEPP 
povidone iodine solution
Product Information
Item Code (Source)NDC:54365-145
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE99.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER867.3 mg  in 1 mL
Packaging
#Item CodePackage Description
1NDC:54365-145-010.67 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/1988
Part 2 of 2
FREPP 
povidone iodine solution
Product Information
Item Code (Source)NDC:54365-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE20.67 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER967 mg  in 1 mL
Packaging
#Item CodePackage Description
1NDC:54365-301-011.1 mL in 1 APPLICATOR
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 (826496312)
Registrant - CareFusion 213 LLC (831684456)
Establishment
NameAddressID/FEIOperations
CareFusion 213 LLC826496312ANALYSIS, MANUFACTURE, PACK, LABEL

Revised: 06/2011
 
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.

Hide
(web3)