Label: TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
- NDC Code(s): 45865-640-01
- Packager: Medsource Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 0472-0179
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated July 27, 2018
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc neomycin sulfate polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45865-640(NDC:0472-0179) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [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:45865-640-01 1 in 1 CARTON 01/01/2018 1 28 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 part333B 05/01/1997 Labeler - Medsource Pharmaceuticals (833685915) Establishment Name Address ID/FEI Business Operations Medsource Pharmaceuticals 833685915 repack(45865-640)