NDC | 37012-027-01, 37012-027-02 |
Set ID | 5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa |
Category | HUMAN OTC DRUG LABEL |
Packager | Shopko Stores Operating Co., LLC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
- Questions?
- PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
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INGREDIENTS AND APPEARANCE
SHOPKO TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-027 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [iU] 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 10000 [iU] in 1 g Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine hydrochloride 10 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:37012-027-01 1 in 1 CARTON 1 14.2 g in 1 TUBE 2 NDC:37012-027-02 1 in 1 CARTON 2 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333B 03/31/2012 Labeler - Shopko Stores Operating Co., LLC (023252638) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(37012-027)