Label: WELLY BRAVERY TRIPLE ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
- NDC Code(s): 72663-162-58
- 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 February 9, 2019
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INGREDIENTS AND APPEARANCE
WELLY BRAVERY TRIPLE ANTIBIOTIC
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72663-162 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 Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 5000 [USP'U] in 1 g Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72663-162-58 1 in 1 CASE 01/31/2019 1 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 01/23/2011 Labeler - Welly Health PBC (116766884) Registrant - Welly Health PBC (116766884) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(72663-162)