Baciguent Ophthalmic Ointment Prescribing Information

Baciguent Ophthalmic Ointment Description

Each gram of ointment contains 500 units of bacitracin in a low melting special base containing White Petrolatum and Mineral Oil.

Baciguent Ophthalmic Ointment - Clinical Pharmacology

The antibiotic, bacitracin, exerts a profound action against many gram-positive pathogens, including the common Streptococci and Staphlococci. It is also destructive for certain gram-negative organisms. It is ineffective against fungi.

Indications and Usage for Baciguent Ophthalmic Ointment

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by bacitracin susceptible organisms.

Contraindications

This product should not be used in patients with a history of hypersensitivity to bacitracin.

Precautions

Baciguent® ophthalmic ointment should not be used in deep-seated ocular infections or in those that are likely to become systemic. The prolonged use of antibiotic containing preparations may result in overgrowth of nonsusceptible organisms particularly fungi. If new infections develop during treatment appropriate antibiotic or chemotherapy should be instituted.

Adverse Reactions/Side Effects

Bacitracin has such a low incidence of allergenicity that for all practical purposes side reactions are practically non-existent. However, if such reaction should occur, therapy should be discontinued.

To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 1-844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Baciguent Ophthalmic Ointment Dosage and Administration

The ointment should be applied directly into the conjunctival sac 1 to 3 times daily. In blepharitis all scales and crusts should be carefully removed and the ointment then spread uniformly over the lid margins. Patients should be instructed to take appropriate measures to avoid gross contamination of the ointment when applying the ointment directly to the infected eye.

How is Baciguent Ophthalmic Ointment supplied

NDC 69784-880-01 3 – 1 g sterile tamper evident tubes with ophthalmic tip.

NDC 69784-880-35 3.5 g (1/8 oz.) sterile tamper evident tubes with ophthalmic tip.

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Manufactured For
Woodward Pharma Services LLC
Wixom, MI 48393

Rev 11-19
5G000 CJ J1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 1 g Label

Rx Only

NDC 69784-880-35

Baciguent®
(Bacitracin Ophthalmic Ointment, USP)

STERILE

NET WT 3.5 g (1/8 oz)

USUAL DOSAGE: Apply 1 to 3 times daily. See package insert for full prescribing information.

Each gram contains: 500 units of bacitracin in a base of white petrolatum and mineral oil.

KEEP TIGHTLY CLOSED

Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature].

KEEP OUT OF REACH OF CHILDREN