NDC | 68169-0129-5 |
Set ID | fce6acbd-0387-4c84-9475-c67647bf3299 |
Category | HUMAN OTC DRUG LABEL |
Packager | TAI GUK PHARM. CO., LTD. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
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ACTIVE INGREDIENT
Active ingredients (in each gram) Purpose
Bacitracin zinc 500 units ......................................................................................First aid antibiotic
Neomycin 3.5 mg ................................................................................................First aid antibiotic
Polymyxin B sulfate 10,000 units ..........................................................................First aid antibiotic
Pramoxine hydrochloride 10 mg ............................................................................Pain reliever
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PREMIER VALUE TRIPLE ANTIBIOTIC PLUS
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68169-0129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 500 [USP'U] in 1 g NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 10000 [USP'U] 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:68169-0129-5 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 11/04/2010 Labeler - TAI GUK PHARM. CO., LTD. (631101656) Registrant - UNITED EXCHANGE CORP. (840130579) Establishment Name Address ID/FEI Business Operations TAI GUK PHARM. CO., LTD. 631101656 manufacture