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Povidone Iodine by Kmart Corporation

Dosage form: solution
Ingredients: povidone-iodine .10mg in 1mL
Labeler: Kmart Corporation
NDC Code: 49738-050

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

ACTIVE INGREDIENT

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

PURPOSE

Antiseptic

USEFirst 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


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

INACTIVE INGREDIENTScitric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide


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



POVIDONE IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49738-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
povidone-iodine (povidone-iodine) povidone-iodine.10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
glycerin 
sodium hydroxide 
water 
Packaging
#Item CodePackage Description
1NDC:49738-050-34236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/13/2006
Labeler - Kmart Corporation (008965873)

Revised: 04/2010
 
Kmart Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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