VETROPOLYCIN- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Vetropolycin by

Drug Labeling and Warnings

Vetropolycin by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products, Altaire Pharmaceuticals, Inc., Xellia Pharmaceuticals Inc., Pharmacia and Upjohn Company, Xellia Pharmaceuticals AS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

STERILE - ANTIBACTERIAL

SPL UNCLASSIFIED SECTION

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

DESCRIPTION

DESCRIPTION: Each gram contains bacitracin zinc 400 units, neomycin sulfate 5 mg (equiv. to 3.5 mg neomycin base), polymyxin B sulfate 10,000 units, in a base of white petrolatum and mineral oil.

VETERINARY INDICATIONS

INDICATIONS: For the treatment of superficial bacterial infections of the eyelid and conjunctiva in dogs and cats when due to organisms susceptible to the antibiotics contained in the ointment.

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

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Apply a thin film over the cornea three to four times daily in dogs and cats. The area should be properly cleansed prior to use. Foreign bodies, crusted exudates, and debris should be carefully removed prior to use.

WARNINGS

WARNING: Do not use this product as a pre-surgical ocular lubricant. Adverse reactions of ocular irritation and corneal ulceration have been reported in association with such use.

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.

SAFE HANDLING WARNING

HUMAN WARNINGS: Keep out of reach of children.

PRECAUTIONS

PRECAUTIONS: Sensitivity to this ophthalmic ointment is rare, however, if a reaction occurs, discontinue use of the preparation. The prolonged use of antibiotic-containing preparations may result in overgrowth of nonsusceptible organisms including fungi.

Appropriate measures should be taken if this occurs.

If infection does not respond to treatment in two or three days, the diagnosis and therapy should be re-evaluated.

Care should be taken to not contaminate the applicator tip of the tube during the application of the preparation. Do not allow the applicator tip to come in contact with any tissue.

ADVERSE REACTIONS

ADVERSE REACTIONS: Itching, burning or inflammation may occur in animals sensitive to the product. Discontinue use in such cases.

For a copy of the Safety Data Sheet (SDS), or to report adverse reactions, call Dechra Veterinary Products at (866) 933-2472.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or http://www.fda.gov/AnimalVeterinary/SafetyHealth

MECHANISM OF ACTION

ACTIONS: The three antibiotics present in Vetropolycin (neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment) Veterinary Ophthalmic Ointment provide a broad spectrum of activity against the gram-positive and gram-negative bacteria commonly involved in superficial infections of the eyelid and conjunctiva.

Bacitracin is effective against gram-positive bacteria including hemolytic and non-hemolytic streptococci and staphylococci.

Resistant strains rarely develop.

Neomycin is effective against both gram-positive and gram-negative bacteria including staphylococci, Escherichia coli and Haemophilus influenzae and many strains of Proteus and Pseudomonas.

Polymyxin B is bactericidal to gram-negative bacteria especially Pseudomonas. No resistant strains have been found to develop in vivo.

STORAGE AND HANDLING

STORAGE INFORMATION: KEEP TIGHTLY CLOSED.

STORE AT 15°-25°C (59° -77°F).

HOW SUPPLIED

HOW SUPPLIED: 3.5 g (1/8 oz) sterile tamper proof tubes.

NDC: 17033-028-38

SPL UNCLASSIFIED SECTION

NADA 065-016, Approved by FDA

Manufactured for:
Dechra Veterinary Products
7015 College Boulevard, Suite 525
Overland Park, KS 66211 USA

Rev. 03/18
Ini0912

PRINCIPAL DISPLAY PANEL - 3.5 g Tube Carton

Vetropolycin®
(neomycin and polymyxin B sulfates and bacitracin zinc
ophthalmic ointment) Veterinary Ophthalmic Ointment

STERILE - ANTIBACTERIAL
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
This product is not for use in food producing animals.
NADA 065-016, Approved by FDA

NET WT 3.5 g (1/8 oz)

Dechra

INGREDIENTS AND APPEARANCE

VETROPOLYCIN 
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-028
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
mineral oil (UNII: T5L8T28FGP)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-028-38	1 in 1 CARTON
1		3.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA065016	04/10/2014

Labeler - Dechra Veterinary Products (362142734)

Establishment
Name	Address	ID/FEI	Business Operations
Altaire Pharmaceuticals, Inc.		786790378	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Xellia Pharmaceuticals Inc.		529171201	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Pharmacia and Upjohn Company		618054084	API MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Xellia Pharmaceuticals AS		305814345	API MANUFACTURE