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

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:

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 865-8000 Case Label

DUKAL™
CORPORATION

REF 865-8000

NON-STERILE POVIDONE-IODINE 10%

POVIDONE-IODINE
PREP PADS

8000/Case

1/Pack

Manufactured For: DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

(01) 40665973024903

Principal Display Panel - PVP-I Prep Pads Foil 865-8000 Case Label

Principal Display Panel - PVP-I Prep Pads Foil 865-8000 Pouch Label

DUKAL™
CORPORATION

REF 865

NON-STERILE
POVIDONE-IODINE 10%

Povidone-Iodine
Prep Pad

1
/Pouch

Manufactured For:

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China

Principal Display Panel - PVP-I Prep Pads Foil 865-8000 Pouch Label
PVP-I PREP PADS FOIL-FOIL 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
NONOXYNOL-10 (UNII: K7O76887AP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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:65517-0031-18000 in 1 CASE01/31/201801/31/2018
1100 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/31/201801/31/2018
Labeler - Dukal Corporation (791014871)

Revised: 8/2018
Document Id: 73a65099-140d-ff99-e053-2991aa0ab2c7
Set id: c6f8f3a4-20ac-47c8-b245-183d442f30b3
Version: 4
Effective Time: 20180817
 
Dukal Corporation