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
- 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 February 10, 2021
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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- Inactive 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 FINAL part333B 09/15/2017 Labeler - STRATUS PHARMACEUTICALS INC (789001641) Establishment Name Address ID/FEI Business Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-012) , LABEL(58980-012) , PACK(58980-012)