Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 58228-5600-0, 58228-5600-1, 58228-5600-2 - Packager: ProStat First Aid
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 20, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients (each gram contains)
- Purpose
- Uses
- Warnings
- Directions
- Other Information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL – ProStat 25 count box
- PRINCIPAL DISPLAY PANEL – Front Line 25 count box
- PRINCIPAL DISPLAY PANEL – packet
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58228-5600 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin 400 [USP'U] 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 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58228-5600-1 25 in 1 BOX 09/20/2013 1 NDC:58228-5600-0 0.5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:58228-5600-2 25 in 1 BOX 09/20/2013 2 NDC:58228-5600-0 0.5 g in 1 PACKET; 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 09/20/2013 Labeler - ProStat First Aid (061263699) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE(58228-5600)