Label: TRIPLICIN- neomycin sulfate and polymyxin b sulfate and bacitracin zinc ointment

  • NDC Code(s): 46066-757-55
  • Packager: Aspen Veterinary Resources
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated February 2, 2022

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

  • SPL UNCLASSIFIED SECTION

    Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment (Sterile) -VETERINARY

    ANADA 200-553, Approved by FDA

  • DESCRIPTION:

    Each gram contains: polymyxin B sulfate 10,000 units, bacitracin zinc 400 units, neomycin sulfate 5 mg (equivalent to 3.5 mg neomycin base) in a white petrolatum base, q.s.

  • ACTIONS:

    Polymyxin B is one of a group of closely related substances produced by various strains of Bacillus polymyxa. The activity of polymyxin B is sharply restricted to gram-negative bacteria. Neomycin, isolated from Streptomyces fradiae, has antibacterial activity in vitro against a wide range of gram-negative and gram-positive organisms. Bacitracin, an antibiotic substance derived from cultures of Bacillus subtilis (Tracy), exerts antibacterial action in vitro against a variety of gram-positive and a few gram-negative organisms.

  • INDICATIONS:

    This product is indicated for the treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to organisms susceptible to one or more of the antibiotics contained in the ointment.

    Laboratory tests should be conducted including in vitro culturing and susceptibility tests on samples collected prior to treatment.

  • PRECAUTIONS:

    If irritation develops discontinue treatment with this drug. If there is no response to treatment in 2 to 3 days, discontinue treatment and re-evaluate diagnosis. Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi.

    Care should be taken not to contaminate the applicator tip during administration of the preparation.

  • ADVERSE REACTIONS:

    Adverse reactions, such as itching, burning, or inflammation may occur in animals sensitive to this product.

  • DOSAGE AND ADMINISTRATION:

    Properly cleanse area to be treated. Foreign bodies, crusted exudates and debris should be carefully removed. Express a small quantity of ointment into the conjunctival sac beneath the lower eyelid three or four times daily. After application hold the eyelids shut for a short time so that a thin film of ointment covers the cornea.

  • HOW SUPPLIED:

    NDC 46066-757-55 Tube of 3.5 g (1/8 oz) with ophthalmic tip.

  • STORAGE:

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temp].

    KEEP OUT OF REACH OF CHILDREN.

    Not for Human Use.

    CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

    Warning: Serious hypersensitivity (anaphylactic) reactions have been reported in cats within 4 hours of application of antibiotic ophthalmic preparations. Some of these reactions have resulted in death.

    Pivetal®
    Manufactured for:
    Aspen Veterinary Resources®, LTD.
    Liberty, MO 64068
    pivetalvet.com
    PVNP00N Rev. 06/20 P339A

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC # 46066-757-55 Pivetal logo

    TRIPLICIN™

    Neomycin and Polymyxin B Sulfates, and

    Bacitracin Zinc Ophthalmic Ointment, USP

    For veterinary use only │Rx only ANADA 200-553, Approved by FDA

    Sterile Ophthalmic Ointment Net Wt. 3.5 g (1/8 oz.)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC # 46066-757-55

    Pivetal logo

    TRIPLICIN™

    OINTMENT

    Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP

    For veterinary use only

    Rx only Sterile Ophthalmic Ointment

    Net Wt. 3.5g (1/8 oz.) ANADA 200-553, Approved by FDA

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    TRIPLICIN 
    neomycin sulfate and polymyxin b sulfate and bacitracin zinc ointment
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:46066-757
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate3.5 mg  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc400 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-757-551 in 1 CARTON
    13.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20055310/05/2020
    Labeler - Aspen Veterinary Resources (627265361)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn117696840MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL