Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
- NDC Code(s): 68016-120-01, 68016-120-02
- Packager: Pharmacy Value Alliance LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated May 11, 2017
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- ACTIVE INGREDIENT
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- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-120 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 Sulfate 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 sucrose (UNII: C151H8M554) cottonseed oil (UNII: H3E878020N) olive oil (UNII: 6UYK2W1W1E) sodium pyruvate (UNII: POD38AIF08) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-120-01 1 in 1 CARTON 05/03/2017 1 14.2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68016-120-02 1 in 1 CARTON 05/03/2017 2 28.4 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 12/15/2015 Labeler - Pharmacy Value Alliance LLC (101668460)