Label: POLYSPORIN FIRST AID ANTIBIOTIC- bacitracin zinc and polymyxin b sulfate ointment
- NDC Code(s): 69968-0060-1, 69968-0060-2, 69968-0060-3, 69968-0060-9
- Packager: Johnson & Johnson Consumer 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 January 11, 2023
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- ACTIVE INGREDIENT
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton
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INGREDIENTS AND APPEARANCE
POLYSPORIN FIRST AID ANTIBIOTIC
bacitracin zinc and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0060 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0060-2 1 in 1 CARTON 07/09/2013 1 28.3 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69968-0060-1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 07/09/2013 3 NDC:69968-0060-3 1 in 1 CARTON 07/09/2013 3 14.2 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:69968-0060-9 144 in 1 CARTON 07/09/2013 4 0.9 g in 1 PACKET; 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 07/09/2013 Labeler - Johnson & Johnson Consumer Inc. (118772437)