Label: ASTONEA FIRST AID- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment

  • NDC Code(s): 77338-302-53, 77338-302-54
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 25, 2024

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  • Active ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg (Equivalent to 3.5 mg Neomycin)

    Polymyxin B sulfate 5000 units

  • Purpose

    First Aid AntibioticFirst Aid AntibioticFirst Aid Antibiotic

  • Uses

    ■ first aid to help prevent infection in  ■ minor cuts ■ scrapes ■ burns

  • Warnings

    For external use only

  • Do not use

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

  • Ask a physician before use in case of

    ■ deep or puncture wounds ■ animal bites ■ serious burns

  • Stop use and consult a doctor if

    ■ the condition persists or gets worse ■ a rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ clean the affected area ■ apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily ■ may be covered with a sterile bandage

  • Other Information

    ■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat and humidity■Tamper evident■Do not use if packet is cut, torn or opened

  • Inactive ingredients

    white petrolatum

  • Package Label

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA  FIRST AID
    bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  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 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-302-530.9 g in 1 PACKET; Type 0: Not a Combination Product05/02/2022
    2NDC:77338-302-5428.3 g in 1 TUBE; Type 0: Not a Combination Product05/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00405/02/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
    Registrant - ASTONEA LABS PRIVATE LIMITED (878533295)
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