Label: TERRAMYCIN- oxytetracycline hydrochloride and polymyxin b sulfate ointment

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated February 8, 2018

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

  • SPL UNCLASSIFIED SECTION

    (Oxytetracycline Hydrochloride and

    Polymyxin B Sulfate Ophthalmic Ointment)

    Antibiotic

    Ophthalmic Ointment

  • DESCRIPTION

    Terramycin (Oxytetracycline Hydrochloride and
    Polymyxin B Sulfate Ophthalmic Ointment) is an antibiotic,
    bright yellow in color, possessing potent antimicrobial
    activity. It is one of the most versatile of the broad-spectrum
    antibiotics, and is effective in the treatment of infections due
    to gram-positive and gram-negative bacteria, both aerobic and
    anaerobic, spirochetes, rickettsiae, and certain of the larger
    viruses.
    Polymyxin B sulfate is one of a group of related antibiotics
    derived from Bacillus polymyxa. The polymyxins are rapidly
    bactericidal, this action being exclusively against
    gram-negative bacteria.
    The broad-spectrum effectiveness of Terramycin against both
    gram-positive and gram-negative organisms is enhanced by
    the particular effectiveness of polymyxin B against infections
    associated with gram-negative organisms, especially those
    due to Pseudomonas aeruginosa, where polymyxin B is the
    antibiotic of choice. In addition, there is evidence to indicate
    that polymyxin B sulfate possesses some antifungal activity.
    The combined antibacterial effect of Terramycin plus polymyxin
    is at least additive and, in many instances, an actual synergistic
    action is obtained.
    Terramycin is an ointment of oxytetracycline hydrochloride and
    polymyxin B sulfate in a special petrolatum base. Each gram
    of ointment contains oxytetracycline HCl equivalent to 5 mg of
    oxytetracycline and 10,000 units of polymyxin B as the sulfate.

  • INDICATIONS AND USAGE

    Terramycin is indicated for the prophylaxis and local treatment of superficial ocular infections
    due to oxytetracycline and polymyxin-sensitive organisms,
    including infections due to streptococci, rickettsiae, E. coli, and
    A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal
    ulcer, blepharitis in dogs, cats, cattle, sheep, and horses;
    ocular infections due to secondary bacterial complications of
    distemper in dogs, and bacterial inflammatory conditions which
     may occur secondary to other infectious diseases in the above species.

  • WARNING

    Serious, life threatening, hypersensitivity
    (anaphylactic) reactions have been reported in some cats
    following application of antibiotic ophthalmic preparations.
    If your cat has swelling of the face, itching, appears weak,
    vomits, or has difficulty breathing within 4 hours of application
    you should discontinue treatment and contact your veterinarian
    immediately.

    Note: The use of oxytetracycline and other antibiotics may result
    in an overgrowth of resistant organisms such as Monilia,
    staphylococci, and other species of bacteria. If new infections
    due to nonsensitive bacteria or fungi appear during therapy,
    appropriate measures should be taken.

  • DOSAGE AND ADMINISTRATION

    Terramycin (Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment)

    should be administered topically to the eye 2–4 times daily.

  • RECOMMENDED STORAGE

    Store at controlled room temperature between 20° to 25°C (68° to 77°F), with excursions

    between 15° to 30°C (59° to 86°F).

  • HOW SUPPLIED

    1/8-oz (3.5-g) tube

  • SPL UNCLASSIFIED SECTION

    For Animal Use Only

    Restricted Drug (California)— Use Only As Directed

    Not for Human Use

    NADA #8-763, Approved by FDA

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

    Made in Switzerland

    Logo

    Revised: June 2017

    23288602

  • PRINCIPAL DISPLAY PANEL - 3.5 g Tube Label

    Terramycin®

    (Oxytetracycline Hydrochloride and

    Polymyxin B Sulfate Ophthalmic Ointment)

    Antibiotic Ophthalmic Ointment

    For animal use only

    1/8-oz (3.5-g) tube

    NADA #8-763, Approved by FDA

    zoetis

    25317402

    Terramycin Op Ointment Carton
  • INGREDIENTS AND APPEARANCE
    TERRAMYCIN 
    oxytetracycline hydrochloride and polymyxin b sulfate ointment
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:54771-1096
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S) OXYTETRACYCLINE HYDROCHLORIDE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1096-13.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA00876301/02/1953
    Labeler - Zoetis Inc. (828851555)