Povidone Iodine (Povidone-Iodine) Solution [Amerisource Bergen] -

POVIDONE IODINE (POVIDONE-IODINE) SOLUTION [AMERISOURCE BERGEN]
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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

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

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

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

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

Labeler - Amerisource Bergen (007914906)

Registrant - Humco Holding Group, Inc. (825672884)

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

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