PVP PREP- 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 Swabstick

Drug Facts

Active Ingredient

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

Purpose

Antiseptic

Use

Antiseptic skin preparation

Warnings

For external use only.

  • Do not use if allergic to Iodine

  • Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases
  • Infection occurs
  • Injuries are deep or puncture wounds or serious burns.

  • Keep out of reach of children
  • In case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately.

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

1% titratable iodine

  • Latex free
  • For hospital or professional use only

Inactive Ingredients

Citric Acid, Glycerol, Nonylphenol ethoxylate, Sodium Hydroxide, Purified water.

PRINCIPAL DISPLAY PANEL - 1.7 mL Pouch Box

DUKAL™
CORPORATION

REORDER
867

STERILE
NDCXXX

4"
PVP-I PREP SWABSTICKS

25
/box
3/pouch

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

D02231207

Principal Display Panel - 1.7 mL Pouch Box
PVP PREP 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0027
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:65517-0027-150 in 1 BOX05/18/201205/18/2012
11.7 mL in 1 POUCH; Type 0: Not a Combination Product
2NDC:65517-0027-225 in 1 BOX05/18/201205/18/2012
25.1 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: 76125dad-a6fe-7a3c-e053-2a91aa0a44ae
Set id: 1b1550a1-7b41-4666-9bd3-6be3b4f95350
Version: 2
Effective Time: 20180917
 
Dukal Corporation