POVIDONE IODINE- povidone-iodine solution

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone Iodine,10% w/v (equivalent to 1% titratable iodine)

PURPOSE

Antiseptic

USE

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns.

WARNINGS

For external use only.

Do not

• use in the eyes
• use on individuals who are allergic or sensitive to iodine
• apply over large areas of the body
  

Discontinue use and ask a doctor

• if condition persists or gets worse
• for use longer than 1 week

Ask a doctor in case of

• deep or 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

• 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
  

SPL UNCLASSIFIED SECTION

OTHER INFORMATION

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

INACTIVE INGREDIENTS

citric acid

dibasic sodium phosphate

nonoxynol-9

glycerin

purified water

sofium hydroxide

Questions

Questions or comments?

1-800-662-3435

www.goodneighborpharmacy.com

LABEL INFORMATION

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
NONOXYNOL-9 (UNII: 48Q180SH9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-053-55	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2005

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/01/2005

Labeler - Amerisource Bergen (007914906)

Registrant - Humco Holding Group, Inc. (825672884)

Establishment
Name	Address	ID/FEI	Business Operations
Humco Holding Group, Inc.		825672884	analysis(24385-053) , manufacture(24385-053) , label(24385-053)