NDC | 45802-143-01, 45802-143-03, 45802-143-70 |
Set ID | 28fff253-ddd4-4669-aa90-b4caf48c905f |
Category | HUMAN OTC DRUG LABEL |
Packager | Padagis Israel Pharmaceuticals Ltd |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- Active ingredients (in each gram)
- Purpose
- Uses
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- Inactive ingredients
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin, polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-143 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 NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) COCOA BUTTER (UNII: 512OYT1CRR) COTTONSEED OIL (UNII: H3E878020N) OLIVE OIL (UNII: 6UYK2W1W1E) SODIUM PYRUVATE (UNII: POD38AIF08) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color WHITE (Translucent) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-143-01 1 in 1 CARTON 05/20/2014 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:45802-143-03 1 in 1 CARTON 05/20/2014 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:45802-143-70 144 in 1 CARTON 05/20/2014 3 .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 05/20/2014 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)