Label: EASY CARE FIRST AID TRIPLE ANTIBIOTIC- 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 December 10, 2020

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  • Active Ingredients

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

    Polymyxin B Sulfate 5000 units

  • Purpose

    First Aid Antibiotic

  • Use

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

  • Warnings


    For external use only.

  • Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body

  • Ask a doctor before use if you have

    • deep puncture wounds
    • animal bites
    • serious burns
  • Stop use and ask a doctor if

    Symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Keep out of Reach of Children

    if swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • adults and children 2 year of age and older: clean the affected area; apply a small amount to the area 1-3 times daily; may be covered with a sterile bandage
    • children under 2 years of age: consult a doctor
  • Inactive Ingredients

    mineral oil, petrolatum

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    EASY CARE FIRST AID TRIPLE ANTIBIOTIC 
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90107-0125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 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)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90107-0125-10.9 g in 1 PACKET; Type 0: Not a Combination Product12/01/2020
    2NDC:90107-0125-210 in 1 BOX12/01/2020
    20.9 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:90107-0125-3100 in 1 CARTON12/01/2020
    30.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/01/2020
    Labeler - Adventure Ready Brands (064437304)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production (Xiamen) Co., Ltd. 421256261manufacture(90107-0125)
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