Label: ASTONEATRIPLE ANTIBIOTIC PAIN RELIEF- bacitracin,neomycin,polymxin, pramoxine ointment

  • NDC Code(s): 77338-229-01
  • Packager: ASTONEA LABS PRIVATE LIMITED
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 27, 2023

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  • DRUG FACTS

  • Active Ingredient

    Bacitracin zinc 500 Units

    Neomycin sulfate (3.5mg)

    Polymyxin B sulfate (10000 units)

    Pramoxine HCI (10mg)

  • Purpose

    First Aid Antibiotic

    external analgesic

  • Uses

    First Aid to help prevent infection and for temporary relief of pain in minor:

    • Cuts
    • Scrapes
    • Burns
  • Warnings

    For external use only.

    Do not use

    If you are allergic to any of the ingredients
    In eyes
    Over large areas of the body

    Ask a Doctor before Use

    Ask Doctor before use if you have:

    • Deep or puncture wouns
    • Animal bites
    • Serious burns

    When using this product

    use only as directed

    Stop Use and ask a Doctor if:

    • You need to use longer than 1 week
    • Condition persists or gets worse
    • rash or other allergic reaction develops

    Keep out of Reach of Children

    If Swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    • adults or children 2 years of age and older:
    • 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
    • Children under 2 years of age: ask doctor
  • Other Information

    • Store at 20° to 25°C (68° to 77°F)
    • do not use if tube seal under cap is broken
  • Inactive Ingredient:

    White Petrolatum

  • Packaging

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ASTONEATRIPLE ANTIBIOTIC PAIN RELIEF 
    bacitracin,neomycin,polymxin, pramoxine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-229
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77338-229-011 in 1 BOX05/01/2023
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00405/01/2023
    Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
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