POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC- povidone-iodine solution

Povidone Iodine Solution First Aid Antiseptic by

Drug Labeling and Warnings

Povidone Iodine Solution First Aid Antiseptic by is a Otc medication manufactured, distributed, or labeled by Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

do not use

• in the eyes or apply over large areas of the body
• longer than 1 week unless directed by a doctor

Ask a doctor before use

in case of deep or puncture wounds, animal bites, or serious burns

Ask A doctor before use if you have

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 between 15° - 30°C (59°-86°F)

Inactive ingredients

 C12-13 Pareth-9, citric acid, disodium phosphate, glycerin, sodium hydroxide, water

disclaimer

This product is not manufactured or distributed by the Purdue Products L.P., distributor of Betadine Solution 10% Povidone-iodine Topical Solution.

Adverse Reactions Section

Manufactured by: Vi-Jon, Inc

St. Louis, MO 63114

Questions or Comments?

1-888-593-0593

050.002/050AE

Principal Display Panel

NDC: 0869-0050-34

Povidone-

Iodine

Solution, 10%

First Aid Antiseptic

Kills Germs in Minor Burns, Cuts, and Scrapes

Compare to Active Ingredint of Betadine

8 FL OZ (237 mL)

Principal Display Panel

mountain

falls

*Compare to

Betadine

used by

hospitals,

doctors,

& nurses

kills germs

in minor

burns, cuts

& scrapes

10%

povidone-

iodine

solution

first aid antiseptic

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

POVIDONE IODINE SOLUTION FIRST AID ANTISEPTIC 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0869-0050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10.34 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
C12-13 PARETH-9 (UNII: 9BXD858P37)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
sodium hydroxide (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0869-0050-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2009
2	NDC: 0869-0050-26	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/07/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/07/2009

Labeler - Vi Jon (790752542)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(0869-0050)