TRIPLICIN by Aspen Veterinary Resources / Akorn Operating Company LLC / Akorn, Inc. TRIPLICIN™

TRIPLICIN by

Drug Labeling and Warnings

TRIPLICIN by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resources, Akorn Operating Company LLC, Akorn, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRIPLICIN- neomycin sulfate and polymyxin b sulfate and bacitracin zinc ointment 
Aspen Veterinary Resources

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TRIPLICIN™

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment (Sterile) -VETERINARY

ANADA 200-553, Approved by FDA

DESCRIPTION:

Each gram contains: polymyxin B sulfate 10,000 units, bacitracin zinc 400 units, neomycin sulfate 5 mg (equivalent to 3.5 mg neomycin base) in a white petrolatum base, q.s.

ACTIONS:

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.

INDICATIONS:

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.

PRECAUTIONS:

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:

Adverse reactions, such as itching, burning, or inflammation may occur in animals sensitive to this product.

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:

NDC: 46066-757-55 Tube of 3.5 g (1/8 oz) with ophthalmic tip.

STORAGE:

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.

Pivetal®
Manufactured for:
Aspen Veterinary Resources®, LTD.
Liberty, MO 64068
pivetalvet.com
PVNP00N Rev. 06/20 P339A

Principal Display Panel Text for Container Label:

NDC # 46066-757-55 Pivetal logo

TRIPLICIN™

Neomycin and Polymyxin B Sulfates, and

Bacitracin Zinc Ophthalmic Ointment, USP

For veterinary use only │Rx only ANADA 200-553, Approved by FDA

Sterile Ophthalmic Ointment Net Wt. 3.5 g (1/8 oz.)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC # 46066-757-55

Pivetal logo

TRIPLICIN™

OINTMENT

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP

For veterinary use only

Rx only Sterile Ophthalmic Ointment

Net Wt. 3.5g (1/8 oz.) ANADA 200-553, Approved by FDA

Principal Display Panel Text for Carton Label
TRIPLICIN 
neomycin sulfate and polymyxin b sulfate and bacitracin zinc ointment
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC: 46066-757
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc400 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 46066-757-551 in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20055310/05/202005/31/2023
Labeler - Aspen Veterinary Resources (627265361)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL

Revised: 11/2023