Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b ointment
- NDC Code(s): 45802-143-01, 45802-143-03, 45802-143-70
- Packager: Padagis Israel Pharmaceuticals Ltd
- 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 March 25, 2022
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin, polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:45802-143 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 PETROLATUM (UNII: 4T6H12BN9U) COCOA BUTTER (UNII: 512OYT1CRR) COTTONSEED OIL (UNII: H3E878020N) OLIVE OIL (UNII: 6UYK2W1W1E) SODIUM PYRUVATE (UNII: POD38AIF08) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Product Characteristics Color WHITE (Translucent) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45802-143-01 1 in 1 CARTON 05/20/2014 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:45802-143-03 1 in 1 CARTON 05/20/2014 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:45802-143-70 144 in 1 CARTON 05/20/2014 3 .9 g in 1 PACKET; 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 05/20/2014 Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)