Label: POVIDONE IODINE - povidone-iodine solution
- NDC Code(s): 49738-050-34
- Packager: Kmart Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated April 15, 2010
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- ACTIVE INGREDIENT
Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine)Close
First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns
For external use only.
- use in the eyes
- use on individuals who are allergic or sensitive to iodine
- apply over large areas of the body
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away.
- 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 INGREDIENTS
citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide Close
- LABEL INFORMATION
Compare to active ingredient of Betadine® Solution*
- First Aid Antiseptic
- Kills germs in minor burns, cuts and scrapes
*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.
Hoffman Estates, IL 60179
Made in USA
- INGREDIENTS AND APPEARANCE
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)