NDC | 55315-180-56 |
Set ID | 41ee7a50-d36b-4214-b6f8-44f47ab44a84 |
Category | HUMAN OTC DRUG LABEL |
Packager | Fred's, Inc. |
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 - 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:55315-180 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) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-180-56 1 in 1 CARTON 11/15/2018 1 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 11/15/2018 Labeler - Fred's, Inc. (005866116)