Animal NDC 54771-1096-1 Terramycin
Oxytetracycline Hydrochloride And Polymyxin B Sulfate

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1096-1
Proprietary Name Terramycin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Oxytetracycline Hydrochloride And Polymyxin B Sulfate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Otc Animal Drug
Usage Information
    Terramycin is indicated for the prophylaxis and local treatment of superficial ocular infectionsdue to oxytetracycline and polymyxin-sensitive organisms,including infections due to streptococci, rickettsiae, E. coli, andA. aerogenes, such as conjunctivitis, keratitis, pink eye, cornealulcer, blepharitis in dogs, cats, cattle, sheep, and horses;ocular infections due to secondary bacterial complications ofdistemper in dogs, and bacterial inflammatory conditions which  may occur secondary to other infectious diseases in the above species.
Active Ingredient(s)
  • Polymyxin B Sulfate
  • Oxytetracycline Hydrochloride
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA008763 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Terramycin Images

Terramycin Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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


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


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.