Label: POLY BACITRACIN- bacitracin zinc and polymyxin b sulfate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 52426-420-05, 52426-420-06 - Packager: Phoenix Global Supply Group, Inc
- 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.
Drug Label Information
Updated September 28, 2010
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- ACTIVE INGREDIENT
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- Inactive ingredient
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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INGREDIENTS AND APPEARANCE
POLY BACITRACIN
bacitracin zinc and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52426-420 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin zinc - UNII:89Y4M234ES) Bacitracin zinc 500 [iU] in 1 g Polymyxin B sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B sulfate 10000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52426-420-05 1 in 1 CARTON 1 14.2 g in 1 TUBE 2 NDC:52426-420-06 1 in 1 CARTON 2 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333B 09/23/2010 Labeler - Phoenix Global Supply Group, Inc (843189908) Establishment Name Address ID/FEI Business Operations Axellia Pharmaceuticals AS 561816174 MANUFACTURE Establishment Name Address ID/FEI Business Operations Axellia Pharmaceuticals ApS 305814345 MANUFACTURE