Label: ASTONEA FIRST AID- bacitracin zinc ointment

  • NDC Code(s): 77338-303-52, 77338-303-53
  • 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 Ingredient (in each gram)

    Bacitracin Zinc (equal to 500 bacitracin units)

  • Purpose

    First Aid Antibiotic

  • Uses

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

  • Warnings

    For external use only

  • Do not use

    ■ Not for opthalmic use Do not use ■ in the eyes ■ if you are allergic to any of the ingredients, due to possibility of anaphylactic shock ■ over large areas of the body ■ longer than 1 week unless directed by a doctor

  • Ask a doctor before use in case of

    ■ deep or puncture wounds

    ■ animal bites ■ serious burns

  • Stop use and ask 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

  • Inactive Ingredients

    hard paraffin, liquid paraffin, white soft paraffin, lanolin

  • Package Label

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEA  FIRST AID
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-303-520.9 g in 1 PACKET; Type 0: Not a Combination Product05/02/2022
    2NDC:77338-303-5328.3 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-303)
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