NDC | 63868-945-94 |
Set ID | dced282a-97f6-44a3-b3ab-bc19912844bd |
Category | HUMAN OTC DRUG LABEL |
Packager | CHAIN DRUG MARKETING ASSOCIATION INC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
ACTIVE INGREDIENT
Active Ingredients (in each gram) Purpose
Bacitracin Zinc 500 units .................................................................................First aid antibiotic
Neomycin Sulfate 3.5 mg.................................................................................First aid antibiotic
Polymyxin-B Sulfate 10,000 units.....................................................................First aid antibiotic
Pramoxine hydrochloride 10 mg........................................................................Pain reliever
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER
bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-945 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 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 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) POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-945-94 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 02/09/2012 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)