Label: WELLY INFECTION FIGHTER- bacitracin zinc, neomycin sulfate, polymyxin b sulfate 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 March 29, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients  (in each gram)

    Bacitracin Zinc (500 units Bacitracin)

    Neomycin Sulfate (3.5 mg Neomycin)

    Polymyxin B Sulfate (Polymyxin B 10,000 units)

  • Purpose

    First aid antibiotic

  • Use

    First aid to help prevent infection in minor: • cuts • scrapes • burns

  • Warnings

    For external use only.

    Do not use: • in the eyes • over large areas of the body • if you are allergic to any of the ingredients.

    Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns.

    Stop use and ask a doctor if 

    • you need to use longer than 1 week

    • condition persists or gets worse

    • symptoms persist for more than 1 week, or clear up and reoccur • rash or other allergic reaction develops.

    Keep out of reach of children.

    • Do not use if pregnant or breastfeeding

  • Directions

    Adults and children 2 years and older:

    • clean affected area • apply a small amount (equal to the surface area of tip of finger) on area 1 to 3 times daily

    • may be covered with a sterile bandage.

    Children under 2 years: ask a doctor.

  • Other information

    Store at a controlled room temperature 68°– 77°F (20°– 25°C)

  • Inactive Ingredients

    Apis Mellifera (Beeswax), Fractionated Coconut Oil, Glyceryl Stearate, Octyldodecanol, PEG-100 Stearate, Theobroma Cocoa (Cocoa Butter)

  • SPL UNCLASSIFIED SECTION

    Triple Antibiotic Ointment
    Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate

    FREE FROM

          x

    Petrolatum

    Parabens

    Sulfates

    Mineral Oil

    Fragrance

    FRAGRANCE FREE

    KID FRIENDLY

    MADE WITH SQUEAKY CLEAN INGREDIENTS FOR HAPPY HEALING

    SQUEAKY CLEAN FIRST AID

    Formulated with naturally derived plant-based ingredients

    COCONUT OIL known to help moisturize skin
    BEESWAX 
    known to help keep skin hydrated
    COCOA BUTTER 
    known to help soften and soothe skin

    HELPS PREVENT INFECTION FROM MINOR

    cuts
    scrapes
    burns
    wounds

    Packaging is recyclable.

    Distributed by Welly Health PBC

    Minneapolis, MN 55402

    1-833-BE-WELLY | getwelly.com

    Product of USA and Canada with globally sourced materials.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    WELLY INFECTION FIGHTER 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [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 B10000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ROYAL JELLY (UNII: L497I37F0C)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-064-011 in 1 CARTON10/01/2021
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B10/01/2021
    Labeler - Welly Health PBC (116766884)