DUKAL POVIDONE-IODINE SCRUB WINGED SPONGES- povidone-iodine scrub winged sponges sponge 
Dukal LLC

----------

65517-0037

Active Ingredient

Povidone-Iodine USP 10%

Purpose

Antiseptic

Use

Patient preoperative skin preparation. Helps to reduc bacteria that potentially can 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 doctor if infection occurs, redness, irritation or swelling develops.

  • Keep out of reach of children
  • If swallowed or gets in eyes, get medical help or contact Poison Control Center right away.

Directions

Apply product to skin as needed.

Other Information:

1% titratable iodine, Avoid excessive heat, Store at room temperature, For hospital or professional use only, Not made with natural rubber latex

Inactive Ingredients:

Alkyl Glucoside, Anhydrous Citric Acid, Glycerin, Nonoxynol-10, Potassium Iodide, Purified Water, Sodium Lauryl Sulfate, Sodium Hydroxide

910Dukal™

Povidone-Iodine

Scrub Winged

Sponges

Sterile, Large

Antispetic

Drug Facts

Active ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation. Helps to reduce bacteria

that potentially can cause skin infection.

Warnings

For external use only.

Do no use if allergic to iodine, in the eyes

Sterile unless package is damagedor opened

2 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0037-1 REF 910

Dukal REF 910

Povidone-Iodine

Scrub Winged Sponges

Sterile, Large

Antiseptic

For Professional and Hospital Use

8 Boxes Per Case

10 Pouches Per Pack

2 Per Pouch

Not Made with Natural Rubber Latex Do not re-use NDC 65517-0037-1

910 Case

912Dukal™

Povidone-Iodine

Scrub Winged

Sponges

Sterile, Small

Antispetic

Drug Facts

Active ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation. Helps to reduce bacteria

that potentially can cause skin infection.

Warnings

For external use only.

Do no use if allergic to iodine, in the eyes

Sterile unless package is damagedor opened

4 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0037-2 REF 912

DUKAL POVIDONE-IODINE SCRUB WINGED SPONGES 
povidone-iodine scrub winged sponges sponge
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-0037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
GLYCERIN (UNII: PDC6A3C0OX)  
NONOXYNOL-10 (UNII: K7O76887AP)  
WATER (UNII: 059QF0KO0R)  
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-0037-12 in 1 POUCH09/15/2022
1109 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:65517-0037-24 in 1 POUCH03/15/2023
2109 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00309/15/2022
Labeler - Dukal LLC (791014871)

Revised: 10/2023
Document Id: 079f8754-babe-2257-e063-6394a90ae966
Set id: e8bce905-929e-30e4-e053-2a95a90a909f
Version: 4
Effective Time: 20231013
 
Dukal LLC