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

    Drug Facts

  • Active ingredients (per gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 3.5 mg

    Polymyxin B Sulfate 5000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

    Do not use:

    • in the eyes
    • internally
    • over large of the body
    • if you are allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use:

    • in case of deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if:

    • condition persists or gets worse
    • a rash or other allergic reaction develops

    Keep this and all drugs out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

  • Directions

    • Clean affected area
    • Apply a small amount of this product (an amount equal to the surface area of tip of finger) on area 1 to 3 times daily
    • May be covered with a sterile bandage
  • Other information

    • Store at room temperature (do not freeze)
    • Do not use any opened or torn packages
  • Inactive ingredient

    white petrolatum

  • Principal Display Panel - 0.5g Carton Label

    FIRST AID

    welly

    Bravely Balm

    TRIPLE ACTION FIRST AID

    ANTIBIOTIC OINTMENT

    COUNT 12

    NET WT 0.02 oz (0.5g)

    TOTAL NET WT 0.21oz (6.0g)

    Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

    Principal Display Panel - 0.5g Carton Label
  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-560
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin400 [iU]  in 1 g
    neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin3.5 mg  in 1 g
    polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K) polymyxin b5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-560-1212 in 1 BOX09/06/2019
    1NDC:72663-560-340.5 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/06/2019
    Labeler - Welly Health PBC (116766884)
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