NDC | 11527-162-51 |
Set ID | 1aa95046-c1f7-4fc7-acac-839065d998f6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Sheffield Pharmaceuticals LLC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- SPL UNCLASSIFIED SECTION
- Active ingredients (In each gram)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
- Questions? 1-800-222-1087
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SHEFFIELD TRIPLE ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11527-162 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 400 [USP'U] in 1 g 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 Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11527-162-51 1 in 1 CARTON 01/23/2011 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:11527-162-30 1 in 1 CARTON 12/22/2020 2 30 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:11527-162-55 1 in 1 CARTON 11/09/2012 3 28 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:11527-162-47 1 in 1 CARTON 01/23/2011 4 9.35 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:11527-162-27 144 in 1 CARTON 10/12/2018 5 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 01/23/2011 Labeler - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 manufacture(11527-162)