PVP-IODINE SWABSTICK THREES- povidone-iodine swab 
Dukal LLC

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65517-0033

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.

  • 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 sponge sticks 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 Swabstick Sterile 883 Pouch Label

Dukal
Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883

883

Principal Display Panel - PVP-I Prep Swabstick Sterile 884 Pouch Label

Dukal
Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

1 Per Pouch - 2 - NDC 6551-0033-1 - REF 884

884

Principal Display Panel - PVP-I Prep Swabstick Sterile 883C Pouch Label

Dukal
Povidone-Iodine

Swabstick

Sterile

Antiseptic

Drug Facts

Active Ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin reparation: Helps to reduce bacteria that potentially can cause skin infection.

Sterile unless package is damaged or opened.

3 Per Pouch - Do not re-use - NDC 6551-0033-3 - REF 883C

883C

PVP-IODINE SWABSTICK THREES 
povidone-iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0033
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)  
POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-0033-11000 in 1 CASE01/31/2018
11 in 1 POUCH
12.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:65517-0033-3500 in 1 CASE01/31/2018
23 in 1 POUCH
21.8 mL in 1 APPLICATOR; 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: 1265f6ab-af80-4965-e063-6394a90ac36b
Set id: 5af20b49-11b1-4b15-bb7f-eccda2c46997
Version: 8
Effective Time: 20240227
 
Dukal LLC