Label: MAJOR POVIDONE IODINE- povidone-iodine ointment
- NDC Code(s): 0904-1102-31
- Packager: Major Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 13, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
For external use only.
Do not use
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
- Other information
- Inactive ingredients
- Principal Display Panel – 1 oz. Tube
- Principal Display Panel – 1 oz. Carton
INGREDIENTS AND APPEARANCE
MAJOR POVIDONE IODINE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-1102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0904-1102-31 1 in 1 CARTON 08/14/2006 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/14/2006 Labeler - Major Pharmaceuticals (191427277)