Label: ASTONEA FIRST AID- bacitracin zinc 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 August 18, 2022

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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 finalpart333B05/02/2022
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-303)
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