Label: TRIPLE ANTIBIOTIC AND PAIN RELIEF- bacitracin,neomycin,polymyxin, pramoxine ointment
- NDC Code(s): 79481-0016-1, 79481-0016-2, 79481-0016-5
- Packager: Meijer
- 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 January 11, 2023
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC AND PAIN RELIEF
bacitracin,neomycin,polymyxin, pramoxine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 500 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [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:79481-0016-2 1 in 1 BOX 06/25/2021 1 2 in 1 PACKAGE, COMBINATION 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:79481-0016-1 1 in 1 BOX 06/25/2021 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:79481-0016-5 1 in 1 BOX 06/25/2021 3 14 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 06/25/2021 Labeler - Meijer (006959555) Registrant - Trifecta Pharmaceuticals USA (079424163)