AFASSCO TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [AFASSCO INC.]

AFASSCO TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [AFASSCO INC.]
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NDC 51532-4605-1, 51532-4605-2
Set ID ed1e3b2f-f6ad-4b18-956e-66f817403007
Category HUMAN OTC DRUG LABEL
Packager Afassco Inc.
Generic Name
Product Class Aminoglycoside Antibacterial
Product Number
Application Number PART333B
  • 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)

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