Your browser does not support JavaScript! POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC (POVIDONE-IODINE) SOLUTION [VI JON]
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POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC (povidone-iodine) solution
[Vi Jon]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredeint
Povidone-iodine, 10%(equivalent to 1% available iodine)

Purpose
Antiseptic

Uses first aid to help prevent the risk of infection in minor cuts, scrapes and  burns

Warnings
For external use only

Ask A doctor before use if you have
• deep or puncture wounds
• animal bites
• serious burns

When using this product
• do not get into eyes.  If contact occurs, rinse eyes thoroughly with water
• do not apply over large areas of the body
• do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if
• condition persists or gets worse

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 on the area 1 to 3 times daily.
• may be covered with a sterile bandage.  If bandaged, let dry first.

Other information
store at room temperature

Inactive ingredients citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

This product is not manufactured or distributed by the Purdue Frederick Company, distributor of Betadine

NDC 0896-0050-34  
Povidone-
Iodine
Solution, 10%
Soluciond de povidona yodada. 10%
First Aid Antiseptic
Antisepito para primeros auxilios
Kills Germs in Monor, Burns, Cuts and Scrapes
Compare to Active Ingredient of Betadine
8 FL OZ (237 mL)
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POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0869-0050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE10 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
NONOXYNOL-9 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0050-34.2 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E05/07/2009
Labeler - Vi Jon (790752542)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture

Revised: 9/2010
 
Vi Jon

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