Label: TRIPLE ANTIBIOTIC PLUS- polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointment
- NDC Code(s): 0713-0622-31
- Packager: Cosette Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- ACTIVE INGREDIENT
- USES
-
WARNINGS
For external use only.
Do not use
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
- longer than 1 week unless directed by a doctor.
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
Stop use and ask a doctor if
- the condition persists or gets worse
- symptoms persist for more than 1 week, or clear up and occur again within a few days
- a rash or other allergic reaction develops
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC PLUS
polymyxin b sulfate, bacitracin zinc, neomycin sulfate, pramoxine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0713-0622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U] in 1 g 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 Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Light Mineral Oil (UNII: N6K5787QVP) Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0713-0622-31 28.4 g in 1 TUBE; Type 0: Not a Combination Product 02/28/1998 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M004 02/28/1998 Labeler - Cosette Pharmaceuticals, Inc. (116918230) Registrant - Cosette Pharmaceuticals, Inc. (116918230) Establishment Name Address ID/FEI Business Operations Cosette Pharmaceuticals NC Laboratories, LLC 079419931 MANUFACTURE(0713-0622)