PVP PREP PAD- 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.

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PVP Prep Pad

Drug Facts

Active Ingredients

Povidone Iodine, USP, 10% w/w (equivalent to 1% titratable iodine)

Purpose

First aid antiseptic

Use

First aid antiseptic to help prevent infection in minor cuts, scrapes, and burns

Warnings

For external use only

  • Do not use in the eyes or apply over large areas of the body longer than one week unless directed by a doctor
  • On individuals who are allergic or sensitive to Iodine

  • Ask a doctor before use if you have deep or puncture wounds; animal bites; serious burns

  • Stop use and ask a doctor if condition persists or gets worse

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

Directions

Clean the treatment area

  • Apply a small amount of this product on the treatment area 1-3 times daily
  • May be covered with a sterile bandage if bandaged, let dry first.

Other Information

Store at room temperature

  • Avoid excessive heat

Inactive Ingredients

Citric Acid, Glycerol, Nonylphenol ethoxylate, Sodium hydroxide, Purified water

PRINCIPAL DISPLAY PANEL - 1 mL Solution Packet Box

DUKAL™
CORPORATION

REORDER
865

STERILE
NDC XXXX

PVP-I PREP PAD

100
Pads

Sterility guaranteed unless package is damaged or opened.

DUKAL CORPORATION•(631) 656-3800
Ronkonkoma, NY 11779•www.dukal.com

DUKAL
Q.V.P
Corporation

Made in China

D02231201

Principal Display Panel - 1 mL Solution Packet Box
PVP PREP PAD 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.2 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorbrownScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-0029-120 in 1 BOX05/18/201205/18/2012
11 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/18/201205/18/2012
Labeler - Dukal Corporation (791014871)

Revised: 9/2018
Document Id: 76128cbd-b06a-9925-e053-2a91aa0a10c7
Set id: 18311ed3-1885-4774-b124-3a0396c188aa
Version: 2
Effective Time: 20180917
 
Dukal Corporation