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

Dukal Povidone-Iodine Scrub Winged Sponges by

Drug Labeling and Warnings

Dukal Povidone-Iodine Scrub Winged Sponges by is a Otc medication manufactured, distributed, or labeled by Dukal LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

• 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 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

PRINCIPAL DISPLAY PANEL

Dukal™

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

Dukal™

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65517-0037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65517-0037-1	2 in 1 POUCH	09/15/2022
1		109 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 65517-0037-2	4 in 1 POUCH	03/15/2023
2		109 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/15/2022

Labeler - Dukal LLC (791014871)