Label: WELLY BRAVERY TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, pramoxine hcl ointment

  • 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 28, 2019

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  • SPL UNCLASSIFIED SECTION

    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:

    • cuts
    • scrapes
    • burns
  • 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

    • Adults and children 2 years of age and older
    • clean the affected area
    • apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
    • may be covered with a sterile bandage
    • Children under 2 years of age; ask a doctor
  • Other information

    • Store at a controlled room temperature 68º-77ºF (20º-25ºC)
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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