PVP-I POUCH FOIL-FOIL- povidone-iodine solution 
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.

----------

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.

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 3/4 Ounce Solution Case Label

DUKAL™
CORPORATION

REF 870-500

NON-STERILE POVIDONE-IODINE 10%

POVIDONE-IODINE
SOLUTION 3/4 OUNCE

500/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) 40665973024910

Principal Display Panel - PVP-I 3/4 Ounce Solution Case Label

Principal Display Panel - PVP-I 3/4 Ounce Solution Pouch Label

DUKAL™
CORPORATION

REF 870

NON-STERILE
POVIDONE-IODINE 10%

POVIDONE-IODINE
SOLUTION
3/4 OUNCE

1
/Pouch

DUKAL CORPORATION • (631) 656-3800

Ronkonkoma, NY 11779 • www.dukal.com

Made in China, Hecho en China, Fabriqué en Chine

D11021703

Principal Display Panel - PVP-I 3/4 Ounce Solution Pouch Label
PVP-I POUCH FOIL-FOIL 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0032
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:65517-0032-1500 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: 73a68a33-f278-c9a9-e053-2a91aa0a3b41
Set id: c5cc7da0-6ee6-4512-a995-93eec9419122
Version: 4
Effective Time: 20180817
 
Dukal Corporation