Label: NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC- neomycin sulfate, polymyxin b sulfate and bacitracin zinc ointment
- NDC Code(s): 59399-135-35
- Packager: Akorn
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated November 3, 2022
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- SPL UNCLASSIFIED SECTION
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.
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.
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:
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:
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.
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
VTNP00N Rev. 05/20
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- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC
neomycin sulfate, polymyxin b sulfate and bacitracin zinc ointment
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:59399-135 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin 3.5 mg in 1 g Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U] in 1 g Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 400 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59399-135-35 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 ANADA ANADA200553 07/30/2015 Labeler - Akorn (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696840 MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL