Label: ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
- NDC Code(s): 72663-560-12, 72663-560-34
- Packager: Welly Health PBC
- 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 November 5, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredients (per gram)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
- Principal Display Panel - 0.5g Carton Label
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INGREDIENTS AND APPEARANCE
ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72663-560 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin 400 [iU] 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 [iU] in 1 g Inactive Ingredients Ingredient Name Strength petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72663-560-12 12 in 1 BOX 09/06/2019 1 NDC:72663-560-34 0.5 g in 1 POUCH; 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 09/06/2019 Labeler - Welly Health PBC (116766884)