Label: TERRAMYCIN- oxytetracycline hydrochloride and polymyxin b sulfate ointment

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

Drug Label Information

Updated October 17, 2024

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

  • SPL UNCLASSIFIED SECTION

    Terramycin®
    (Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment)
    Antibiotic Ophthalmic Ointment

  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • 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 Pseudomonasaeruginosa, 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
    Not for Human Use


    Approved by FDA under NADA # 008-763

    zoetis

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Logo

    Revised: June 2022

    23288603

  • PRINCIPAL DISPLAY PANEL - 3.5 g Tube Label

    15026101

    tube label
  • INGREDIENTS AND APPEARANCE
    TERRAMYCIN 
    oxytetracycline hydrochloride and polymyxin b sulfate ointment
    Product Information
    Product TypePRESCRIPTION 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)