POVIDONE IODINE- povidone-iodine solution

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine by is a Otc medication manufactured, distributed, or labeled by Kmart Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Povidone Iodine USP, 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, glycerin, nonoxynol-8, purified water, sodium hydroxide

QUESTIONS

LABEL INFORMATION

Compare to active ingredient of Betadine® Solution*

NDC: 49738-050-34

AMERICAN FARE

POVIDONE-
IODINE
SOLUTION

• First Aid Antiseptic
• Kills germs in minor burns, cuts and scrapes
  

8 fl. oz. (236 mL)

*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.

If you are not completely satisfied with this or any American Fare product, please call 1-800-842-7886.

Distributed by:
Kmart Corporation
Hoffman Estates, IL 60179
Made in USA

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49738-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
povidone-iodine (UNII: 85H0HZU99M) (povidone-iodine - UNII:85H0HZU99M)	povidone-iodine	.10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
citric acid monohydrate (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
sodium hydroxide (UNII: 55X04QC32I)
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49738-050-34	236 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/13/2006

Labeler - Kmart Corporation (008965873)