NDC | 50382-008-01, 50382-008-02, 50382-008-03, 50382-008-04 |
Set ID | f562f46c-a764-44f5-b8f4-2d4e97489691 |
Category | HUMAN OTC DRUG LABEL |
Packager | Galentic Pharma (India) Private Limited |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- Purpose:
- Indications and Usage:
- Other information
- Inactive ingredients:
- Keep Out Of Reach Of Children
- Warnings
- Dosage and Administration
- Do Not Use:
- Stop use and ask a doctor if
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-008-01 28.35 g in 1 TUBE 2 NDC:50382-008-02 14.17 g in 1 TUBE 3 NDC:50382-008-03 56.7 g in 1 TUBE 4 NDC:50382-008-04 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/07/2013 Labeler - Galentic Pharma (India) Private Limited (918531450)