Label: IODINE TOPICAL SOLUTION - povidone-iodine solution
- NDC Code(s): 41250-677-94
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Povidone Iodine,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
povidone iodine USP, 10%
HELPS PREVENT INFECTION IN MINOR CUTS, SCRAPES AND BURNS
MEIJER PHARMACIST RECOMMENDED
COMPARE TO BETADINE®
8 FL OZ (236 mL)
DIST. BY MEIJER
GRAND RAPIDS, MI 49544
*This product is not manufactured of distributed by Purdue Frederick, owner of the registered trademark, Betadine®.
- INGREDIENTS AND APPEARANCE
IODINE TOPICAL SOLUTION
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-677 Route of Administration TOPICAL DEA Schedule 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:41250-677-94 236 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/02/2004 Labeler - Meijer Distribution Inc (006959555)