Label: WELLY BRAVERY TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl ointment
- NDC Code(s): 72663-161-60
- Packager: Welly Health PBC
- Category: HUMAN OTC DRUG LABEL
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 28, 2019
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (In each gram)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
- Questions? 1-833-BE-WELLY
- Principal Dispaly Panel -Tube
- Principal Display Panel -Case
-
INGREDIENTS AND APPEARANCE
WELLY BRAVERY TRIPLE ANTIBIOTIC WITH PAIN RELIEF
bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72663-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [USP'U] in 1 g Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U] in 1 g Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin 3.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 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:72663-161-60 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 01/31/2019 Labeler - Welly Health PBC (116766884) Registrant - Welly Health PBC (116766884) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(72663-161)