PVP-I PREP PADS FOIL-FOIL- povidone-iodine swab 
Dukal LLC

----------

65517-0034

Active Ingredient:

Povidone Iodine USP 10%

Purpose:

Antiseptic

Use:

For preparation prior to surgery. Helps to reduce bacteria that can potentially cause skin infection.

Warnings:

For external use only.

Do not apply to persons allergic to iodine. Do not use in the eyes.

  • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

  • Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours, infection occurs.
  • Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

  • Keep out of reach of children
  • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

Directions:

Clean the area. Apply product to the operative site prior to surgery using pad to prep desired area.

Other Information:

1% titratable iodine, for hospital or professional use only. Store at ambient temperatures.

Inactive Ingredients:

Citric Acid, Glycerin, Sodium Hydroxide, Potassium Iodide, Alkyl Glucoside, Nonoxynol-10, Hydroxyethyl Cellulose and Purified Water.

Principal Display Panel - PVP-I Prep Pads Foil Pouch Label

Dukal
Povidone-Iodine Prep Pad

Sterile

Antiseptic

For Professional and Hospital Use

Not made with natura rubber latex

Sterile unless package is damaged or opened.

Manufactured For: Dukal, LLC

1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC

1 Per Pouch - 2 - NDC 6551-0034-1 - REF 882

882

Principal Display Panel - PVP-I Prep Pads Paper Pouch Label

Dukal
Povidone-Iodine Prep Pad

Sterile

Antiseptic

For Professional and Hospital Use

Not made with natura rubber latex

Sterile unless package is damaged or opened.

Manufactured For: Dukal, LLC

1(800)243-0741 / Ronkonkoma, NY 11779 / dukal.com

Made in China

Dukal is a trademark registered in the

US Patent & Trademark Office by Dukal, LLC Rev1

1 Per Pouch - 2 - NDC 6551-0034-2 - REF 889

889

PVP-I PREP PADS FOIL-FOIL 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
NONOXYNOL-10 (UNII: K7O76887AP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-0034-18000 in 1 CASE01/31/2018
10.5 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:65517-0034-24000 in 1 CASE01/31/2018
20.5 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00301/31/2018
Labeler - Dukal LLC (791014871)

Revised: 2/2024
Document Id: 1270fb3e-f006-7b1a-e063-6394a90ad7e0
Set id: 95c35c0d-bebb-46d0-8e97-f3d2541723ad
Version: 9
Effective Time: 20240228
 
Dukal LLC