NDC | 61010-5603-2, 61010-5603-4 |
Set ID | 2c2aa8af-2adb-4f59-ac20-15818d0e28e7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Safetec of America, Inc. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each gram)
- Purposes
- Uses
- Warnings
- Do not use:
- Ask a doctor before use:
- Stop use and ask a doctor if:
- Keep this and all drugs out of the reach of children.
- Directions
- Other Information
- Inactive Ingredient
- Questions or Comments? 1-800-456-7077
- PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label
- PRINCIPAL DISPLAY PANEL – Box Label
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-5603 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 3.5 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:61010-5603-4 144 in 1 BOX 03/30/2007 1 NDC:61010-5603-2 0.5 g in 1 POUCH; 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 03/30/2007 Labeler - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(61010-5603)