POVIDONE-IODINE GEL- povidone-iodine gel

Povidone-Iodine Gel by

Drug Labeling and Warnings

Povidone-Iodine Gel 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 reduce bacteria that potentially can cause skin infection.

Warnings

For External Use Only

Do not use

• if allergic to iodine
• in the eyes

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burn

Stop use and ask doctor

• infection occurs
• redness, irritation or swelling develops

Keep out of reach of children

If swallowed, 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, Citric Acid, Glycerin, Hydroxyethyl Cellulose, Nonoxynol-10, Potassium Iodide, Sodium hydroxide, Water

Principle Display Panel

Duka

Povidone-Iodine

Gel

Non-Sterile

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.

1 fl oz (29.5ml) Do not re-use NDC-66517-0070-1 REF 916

INGREDIENTS AND APPEARANCE

POVIDONE-IODINE GEL 
povidone-iodine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65517-0070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
POTASSIUM IODIDE (UNII: 1C4QK22F9J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65517-0070-1	29.5 mL in 1 POUCH; Type 0: Not a Combination Product	01/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/21/2025

Labeler - Dukal LLC (791014871)