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 more69396-002-25
- Packager: TRIFECTA PHARMACEUTICALS USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 May 17, 2023
If you are a consumer or patient please visit this version.
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- 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
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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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/10/2015 Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163) Registrant - Trifecta Pharmaceuticals USA (079424163)
