LEADER POVIDONE - IODINE- povidone-iodine solution
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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LEADER Povidone - Iodine Solution

Active Ingredient

Povidone-Iodine, 10% (Equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

Health-care antiseptic for preparation of the skin prior to surgery
First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Warnings

For external use only.

Do not use

in the eyes
as a first aid antiseptic longer than one week
on individuals who are allergic or sensitive to iodine
over large areas of the body

Stop use and ask a doctor

if condition persists or gets worse
if irritation and redness develop and persist for over 72 hours

Ask a doctor in case of

deep puncture wounds
animal bites
serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For preparation of the skin prior to surgery:

apply to the operative site prior to surgery.

As a first aid antiseptic:

clean the affected area
apply a small amount of this product to the area 1-3 times daily
may be covered with a sterile bandage
if bandaged, let dry first.

Other Information

Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

Inactive Ingredients

citric acid, disodium phosphate, glycerin, nonoxynol-9, sodium hydroxide, and purified water.

LEADER Povidone - Iodine Solution 8oz/237ml (37205-186-34)

Povidone

LEADER POVIDONE - IODINE
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-186
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-186-34	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/26/2012	12/31/2020

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc (825672884)

Name	Address	ID/FEI	Business Operations
Establishment
Humco Holding Group, Inc		825672884	manufacture(37205-186) , analysis(37205-186) , pack(37205-186) , label(37205-186)

Revised: 7/2022

Document Id: e42a0187-e15e-b09a-e053-2995a90a85ab

Set id: 8d1677c7-d8f6-4155-9a9b-dc58aa9a5b23

Version: 5

Effective Time: 20220719

Cardinal Health