Label: TRIPLE ANTIBIOTIC- polymyxin b sulfate, bacitracin zinc and neomycin sulfate ointment
- NDC Code(s): 63187-623-01
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0713-0268
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 1, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT (in each gram)
- PURPOSE
- 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
• a rash or other allergic reaction develops - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
polymyxin b sulfate, bacitracin zinc and neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-623(NDC:0713-0268) 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 5000 [USP'U] in 1 g Neomycin Sulfate (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 400 [USP'U] 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:63187-623-01 1 in 1 CARTON 11/11/2022 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M004 01/11/1995 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-623)