Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment
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NDC Code(s):
69396-002-05,
69396-002-09,
69396-002-20,
69396-002-22, view more69396-002-23, 69396-002-25, 69396-002-44
- Packager: TRIFECTA PHARMACEUTICALS USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 29, 2024
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- Official Label (Printer Friendly)
- Active ingredients (each gram contains)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings For external use only.
Do not use ● in the eyes ● over large areas of the body
● if you are allergic to any of the ingredients.
Ask a doctor before use if you have
● deep or puncture wounds ● animal bites ● serious burns.
Stop use and ask a doctor if ● condition persists or gets worse
● you need to use longer than 1 week
● a rash or other allergic reaction develops
- Directions
- INACTIVE INGREDIENT
- Other information
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-002 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 LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-002-20 1 in 1 BOX 03/13/2017 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-002-05 1 in 1 BOX 08/23/2016 2 15 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:69396-002-09 144 in 1 BOX 03/09/2022 3 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:69396-002-25 25 in 1 BOX 03/14/2023 4 0.9 g in 1 PACKET; Type 0: Not a Combination Product 5 NDC:69396-002-22 1 in 1 BOX 02/01/2022 5 57 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:69396-002-23 2 in 1 BOX 02/29/2024 6 28.4 g in 1 TUBE; Type 0: Not a Combination Product 7 NDC:69396-002-44 4 in 1 BOX 02/29/2024 7 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 03/10/2015 Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163) Registrant - Trifecta Pharmaceuticals USA (079424163)