Label: BACITRACIN ZINC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 58980-012-01, 58980-012-05
- Packager: STRATUS PHARMACEUTICALS INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 1, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 0.9 g Packet Box
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INGREDIENTS AND APPEARANCE
BACITRACIN ZINC
bacitracin zinc and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color WHITE (OFF WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-012-01 144 in 1 BOX 09/15/2017 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:58980-012-05 1 in 1 BOX 02/08/2021 2 14.2 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 drug M004 09/15/2017 Labeler - STRATUS PHARMACEUTICALS INC (789001641) Establishment Name Address ID/FEI Business Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-012)