Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
- NDC Code(s): 69396-135-10, 69396-135-25
- Packager: Trifecta Pharmaceuticals USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2023
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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:69396-135 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength WHITE PETROLATUM (UNII: B6E5W8RQJ4) LIGHT MINERAL OIL (UNII: N6K5787QVP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-135-10 10 in 1 CARTON 10/23/2023 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69396-135-25 25 in 1 CARTON 10/23/2023 2 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 Drug M004 10/23/2023 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)