Label: AFASSCO 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 January 12, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient (in each gram)

    Bacitracin Zinc           400 units

    Neomycin Sulfate      (3.5mg Neomycin)

    Polymyxin B Sulfate   5000 units

  • PURPOSE

    Purpose 

    First Aid Antibiotics

  • INDICATIONS & USAGE

    Uses first aid to help prevent

    infection in minor cuts,

    scrapes, and burns.

  • WARNINGS

    Warnings

    For external use only

    Do not use ■ internally ■ in

    eyes ■ over large areas of

    the body or on puncture wounds,

    animal bites or serious burns

    ■ for more than 1 week unless

    directed by a doctor ■ if you

    are allergic to any of the

    ingredients

  • STOP USE

    Stop use and ask a doctor if

    ■ a rash or allergic reaction

    develops ■ condition worsens

    or persists

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If ingested, contact a  Poison

    Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions ■ clean affected

    area ■ apply a small amount

    1 to 3 times daily ■ may cover

    with a sterile bandage

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Petrolatum, Mineral Oil,

    Purified Water

  • Principal Display Panel

    Afassco¦ ¦®

    The First Choice

    in First Aid

    MAXIMUM STRENGTH TRIPLE

    ANTIBIOTIC OINTMENT

    UNIT DOSE - ANTI-INFECTION TRIPLE ACTION: BACITRACIN ZINC, NEOMYCIN & POLYMYXIN B.

    USE ON CUTS WHEN INFECTION IS EVIDENT.

    No. 331               6 ct.

    MAXIMUM STRENGTH TRIPLE

    ANTIBIOTIC OINTMENT

    6 ct.

    MAXIMUM STRENGTH TRIPLE

    ANTIBIOTIC OINTMENT

    6 ct.

    MAXIMUM STRENGTH ANTIBIOTIC OINTMENT

    (Bacitracin Zinc-Neomycin-Polymyxin B) First aid antibiotic plus topical pain reliever.

    NET WT. 1 gm​Each gram contains 400 units of Bacitracin Zinc, Neomycin Sulfate equivalent to 3.5 mg of Neomycin base, 5000 units of Polymyxin B Sulfate

    in a  white pertroleum base.

    INDICATIONS: First aid to help prevent infection and for the temporary relief of pain or discomfort i minor cuts, scrapes and burns.

    DIRECTIONS: Clean the affected area.  Apply a small amount of this product (an amount equal to the tip of a finger) on on the area 1 to 3

    daily.  May be covered with sterile bandage.  Children under 2 years of age consult a physician.

    LOT NO. & EXP DATE: Unit dose FOR EXTERNAL USE ONLY.  NOT FOR OPTHALMIC USE.  Store at controlled room temperature 15-30 C (59-86 F).

    WARNINGS: For external use only.

    DO NOT USE: Internally, in the eyes, over large aeas of the body or puncture wounds, animal bites or serious burns, for more than a week

    unless directed by a doctor or if you are allergic to any of the ingredients.

    ANTI-INFECCION CON TRIPLE ACCION UNA / AYUDA EN CURRAR LAS HERIDAS

    Solo para el  uso topico, para ayudar en la prevencion de infecciones en las cortaduras menoras, quemadoras y abrasiones.

    INDICACIONES PARA EL USO: Apliquese a la area afectada 2 a 5 veces diariamente. No use en los ojos.

    Afassco¦ ¦® ANZI Z308.1 Manufactured for Afassco, Inc., Minden, NV 89423

    6 ct,

    MAXIMUM STRENGTH TRIPLE

    ANTIBIOTIC OINTMENT

    6 70254 20331 3

    ↓Principal Display 6 ct. Package↓

    51532-4605 6ct Box.jpg

    ↓25 ct. Package↓

    TripleOint 25ct-4605.jpg

    ↓Unit Dose Package↓

    Afassco¦ ¦®

    The First Choice in First Aid

    Triple Antibiotic Ointment

    Manufactured for

        Afassco

    Minden, NV 89423

    ​1 gm (1/32 oz)

    Made in China

    Trpl Antibiotic Pack.jpg

    Triple Antibiotic Ointment by Afassco

    res

  • INGREDIENTS AND APPEARANCE
    AFASSCO TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-4605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  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 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51532-4605-16 in 1 BOX12/07/2018
    11 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:51532-4605-225 in 1 BOX12/07/2018
    21 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/07/2018
    Labeler - Afassco Inc. (609982723)
    Registrant - Afassco Inc. (956159800)