LEADER POVIDONE - IODINE- povidone-iodine solution

LEADER Povidone - Iodine by

Drug Labeling and Warnings

LEADER Povidone - Iodine by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Humco Holding Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

LEADER POVIDONE - IODINE 
povidone-iodine solution

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

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

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

Labeler - Cardinal Health (097537435)

Registrant - Humco Holding Group, Inc (825672884)

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