LEADER POVIDONE-IODINE 10% TOPICAL SOLUTION- povidone iodine prep solution 10% liquid

Leader Povidone-Iodine 10% Topical Solution by

Drug Labeling and Warnings

Leader Povidone-Iodine 10% Topical Solution by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Dynarex Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

For external use only

Do Not Use

• if allergic to iodine
• in the eyes

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Inactive Ingredients

Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP

Active Ingredient

Povidone-iodine 10%

Purpose

Healthcare Antiseptic

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Directions

Clean the area. Apply product to the operative site prior to surgery.

Other

Store at controlled room temperature 15º-30ºC (59º-86ºF).

Questions?

1-888-396-2739

Labeling

INGREDIENTS AND APPEARANCE

LEADER POVIDONE-IODINE 10% TOPICAL SOLUTION 
povidone iodine prep solution 10% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0060-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/25/2020

Labeler - Cardinal Health (063997360)

Registrant - Dynarex Corporation (008124539)