LEADER POVIDONE IODINE- povidone iodine 10% liquid liquid

Leader Povidone Iodine by

Drug Labeling and Warnings

Leader Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba Leader. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone-Iodine 10%

INDICATIONS & USAGE

First aid antiseptic to help prevent infection in minor cuts, scrapes and burns

DOSAGE & ADMINISTRATION

• Clean the affected area
• apply a small amount on the area 1 to 3 times dailly
• may be covered with sterile bandage
• if bandaged let dry first

WARNINGS

Warnings For External use only.

Ask a doctor before use if you have

deep or puncture wounds

animal bites

serious burns

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

Citric Acid

Disodium Phosphate

Glycerin

Nonoxynol-9

Sodium Hydroxide

Purified Water

PURPOSE

First Aid Antiseptic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LEADER POVIDONE IODINE 
povidone iodine 10% liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0402
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0402-1	237 mL in 1 CONTAINER; Type 0: Not a Combination Product	02/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/26/2019

Labeler - Cardinal Health (097537435)