NDC | 46122-414-03, 46122-414-05 |
Set ID | f3c9b5cf-790a-46c6-94eb-4f866deac1e5 |
Category | HUMAN OTC DRUG LABEL |
Packager | AmerisourceBergen |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 14.2 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:46122-414 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 cocoa butter (UNII: 512OYT1CRR) 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:46122-414-05 1 in 1 CARTON 04/04/2017 1 14.2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:46122-414-03 1 in 1 CARTON 04/04/2017 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 - AmerisourceBergen (007914906)