WELLY BRAVERY TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl ointment 
Welly Health PBC

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 Facts

Active ingredients (In each gram)

Bacitracin 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine HCL 10 mg/g

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever 

Uses

First aid to help prevent infection and temporarily relieves pain due to minor:

Warnings

For external use only

Allergy alert:

  • do not use if you are allergic to any of the ingredients

Do not use

  • in or near the eyes
  • on large areas of the body

Consult a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not use longer than 1 week

Stop use and consult a doctor if

  • condition persists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a rash or other allergic reaction develops

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredient

Petrolatum

Questions? 1-833-BE-WELLY

Principal Dispaly Panel -Tube 

Welly First aid NDC 72663-161-60

Triple Action First Aid Antibiotic & Pain Relieving Ointment  

NET WT 0.5 oz (14g)

Bacitracin Zinc, Neomycin Sulfate, Polymixin B Sulfat, Pramoxine HCL

Principal Dispaly Panel -Tube

Principal Display Panel -Case

Principal Display Panel -Case

Welly  Bravery Balm  First Aid    NDC 72663-161-60

Bravery Balm

Triple Action First aid Antibiotic & Pain Relieving Ointment 

NET WT 0.50 oz (14g)

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine HCL

Principal Display Panel -Case

WELLY BRAVERY TRIPLE ANTIBIOTIC WITH PAIN RELIEF 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-161
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72663-161-601 in 1 CASE01/31/2019
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/31/2019
Labeler - Welly Health PBC (116766884)
Registrant - Welly Health PBC (116766884)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(72663-161)

Revised: 2/2019
Document Id: 023cafb4-3709-43d4-8e78-b8eb1eaef4ee
Set id: 3b946693-0688-42a8-99ad-175ef87b7331
Version: 2
Effective Time: 20190228
 
Welly Health PBC